Gemcitabine Hydrochloride and Docetaxel With or Without Bevacizumab in Treating Patients With Advanced or Recurrent Uterine Leiomyosarcoma



Status:Terminated
Conditions:Cervical Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:7/15/2017
Start Date:November 2009
End Date:September 2015

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A Randomized Phase III Evaluation of Docetaxel (NSC #628503) and Gemcitabine (NSC #613327) Plus G-CSF With Bevacizumab (NSC #704865) Versus Docetaxel (NSC #628503) and Gemcitabine (NSC #613327) Plus G-CSF With Placebo in the Treatment of Recurrent or Advanced Leiomyosarcoma of the Uterus

This randomized phase III trial is studying gemcitabine hydrochloride, docetaxel, and
bevacizumab to see how well they work compared with gemcitabine hydrochloride, docetaxel, and
a placebo in treating patients with advanced or recurrent uterine leiomyosarcoma. Drugs used
in chemotherapy, such as gemcitabine hydrochloride and docetaxel, work in different ways to
stop the growth of tumor cells, either by killing the cells or by stopping them from
dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different
ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and
help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the
growth of tumor cells by blocking blood flow to the tumor. It is not yet known whether
gemcitabine hydrochloride and docetaxel are more effective when given with or without
bevacizumab in treating uterine leiomyosarcoma.

PRIMARY OBJECTIVES:

I. To determine whether the addition of bevacizumab to fixed-dose rate gemcitabine-docetaxel
reduces the progression-free survival (PFS) event rate when compared to gemcitabine-docetaxel
plus placebo in patients with advanced or recurrent uterine leiomyosarcoma (LMS).

SECONDARY OBJECTIVES:

I. To determine the objective response rate, as measured by RECIST, of patients treated with
fixed-dose rate gemcitabine-docetaxel with bevacizumab, compared with the objective response
rate of patients treated with fixed-dose rate gemcitabine-docetaxel with placebo.

II. To determine if the addition of bevacizumab to the combination of gemcitabine and
docetaxel increases overall survival in patients with advanced or recurrent uterine LMS.

III. To determine the toxicity profile of fixed-dose rate gemcitabine-docetaxel with and
without bevacizumab in this patient population.

IV. To bank formalin-fixed and paraffin-embedded (FFPE) tumor tissue for research.

OUTLINE: This is a multicenter study. Patients are stratified according to prior whole-pelvic
radiotherapy (yes vs no). Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive a placebo IV over 30-90 minutes on day 1, gemcitabine hydrochloride
IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also
receive filgrastim subcutaneously (SC) on days 9-15 or pegfilgrastim SC on day 9 or 10.

ARM II: Patients receive bevacizumab IV over 30-90 minutes on day 1, gemcitabine
hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8.
Patients also receive filgrastim SC on days 9-15 or pegfilgrastim SC on day 9 or 10.

In both arms, courses repeat every 21 days in the absence of disease progression or
unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years and
then every 6 months for 3 years.

Inclusion Criteria:

- Patients must have advanced or recurrent uterine leiomyosarcoma with documented
disease progression; histologic confirmation of the original primary tumor is required

- All patients must have measurable disease as defined by RECIST 1.1; measurable disease
is defined as at least one lesion that can be accurately measured in at least one
dimension (longest diameter to be recorded); each lesion must be >= 10 mm when
measured by CT, MRI or caliper measurement by clinical exam; or >= 20 mm when measured
by chest x-ray; lymph nodes must be >= 15 mm in short axis when measured by CT or MRI

- Patient must have at least one "target lesion" to be used to assess response on this
protocol as defined by RECIST 1.1; tumors within a previously irradiated field will be
designated as "non-target" lesions unless progression is documented or a biopsy is
obtained to confirm persistence at least 90 days following completion of radiation
therapy

- Patients must have a GOG Performance Status of 0, 1, or 2

- Patients must have recovered from effects of recent surgery, radiotherapy or other
therapy

- Patients should be free of active infection requiring antibiotics (with the exception
of an uncomplicated UTI)

- Any hormonal therapy directed at the malignant tumor must be discontinued at least one
week prior to first day of study treatment; continuation of hormone replacement
therapy is permitted

- Platelet count greater than or equal to 100,000/mm^3

- ANC count greater than or equal to 1,500/mm^3

- Creatinine less than or equal to 1.5 x institutional upper limit normal (ULN), per NCI
CTCAE Version 4.0 Grade 1

- Bilirubin within normal range (CTCAE Version 4 Grade 0)

- SGOT and alkaline phosphatase less than or equal to 2.5 x ULN, per the CTCAE Version
4.0 Grade 1)

- SGOT less than or equal to 2.5 x ULN, per the CTCAE Version 4.0 Grade 1

- Alkaline phosphatase less than or equal to 2.5 x ULN, per the CTCAE Version 4.0 Grade
1

- Neuropathy (sensory and motor) less than or equal to Grade 1 per the CTCAE Version
4.0.

- No history of transient ischemic attack (TIA) or stroke or CNS hemorrhage within the
past 6 months

- Urine protein creatinine (UPC) ratio must be < 1.0 gm; if UPC ratio >= 1, collection
of 24-hour urine measurement of urine protein is recommended

- PT such that international normalized ratio (INR) is =< 1.5 and a PTT =< 1.5 times the
institutional upper limit of normal (or an in-therapeutic-range INR, usually between 2
and 3, if a patient is on a stable dose of therapeutic warfarin)

- Patients must have signed an approved informed consent and authorization permitting
release of personal health information

- Patients must meet pre-entry requirements

- Patients of childbearing potential must have a negative serum pregnancy test prior to
the study entry and be practicing an effective form of contraception

Exclusion Criteria:

- Patients who have received prior cytotoxic chemotherapy for management of uterine
sarcoma; patients who have received prior VEGF-pathway targeted agent such as
bevacizumab, PTK787, VEGF-trap, or who have received prior treatment with a
multi-kinase inhibitor such as sorafenib or sunitinib are not eligible

- Patients who have had prior therapy with docetaxel or gemcitabine or bevacizumab

- Patients with a history of other invasive malignancies, with the exceptions of
non-melanoma skin cancer, carcinoma in situ of the cervix, and ductal carcinoma in
situ of the breast, are excluded if there is any evidence of other malignancy being
present within the last five years; patients are also excluded if their previous
cancer treatment contraindicates this protocol therapy

- Patients with active bleeding or pathologic conditions that carry high risk of
bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major
vessels; (necessary use of warfarin or low molecular weight heparin is permitted,
provided the INR is maintained in the therapeutic range of approximately 2-3)

- Patients with major surgery or significant traumatic injury within 28 days prior to
study entry

- Patients with a history of abdominal fistula or perforation within the past 12 months

- Patients with a current, serious, non-healing wound, ulcer, or bone fracture

- Patients with history or evidence upon physical examination of CNS disease, including
history of primary brain tumor, or any history of brain metastases, or seizures not
controlled with standard medical therapy

- Patients with known hypersensitivity to Chinese hamster ovary cell products or other
recombinant human or humanized antibodies

- Cardiovascular function; specifically, patient may not have:

- Uncontrolled hypertension, defined as systolic > 150 mm Hg or diastolic > 100 mm
Hg in a patient with no history of hypertension; patients with a history of
hypertension before enrollment on study are permitted, but such patients must
have BP less than or equal to 140/90 mmHg; use of blood pressure medications to
achieve and maintain blood pressure control is permitted

- Myocardial infarction or unstable angina within 6 months of the first date of
bevacizumab/placebo therapy

- New York Heart Association (NYHA) Grade II or greater congestive heart failure or
serious cardiac arrhythmia requiring medication; women who have received prior
treatment with an anthracycline (including doxorubicin and/or liposomal
doxorubicin) and have an ejection fraction < 50% will be excluded from the study

- Grade 1, Category 2 or greater, peripheral vascular disease; patient cannot have
anything worse than mild, symptomatic claudication with exercise

- History of cerebrovascular accident (CVA, stroke), transient ischemic attack
(TIA) or subarachnoid hemorrhage within six months of the first date of
bevacizumab/placebo therapy

- History of pulmonary embolism or deep vein thrombosis in the past 6 months

- Patients with, or with anticipation of, invasive procedures as defined below:

- Major surgical procedure, open biopsy or significant traumatic injury within 28
days prior to the first date of bevacizumab/placebo therapy

- Major surgical procedure anticipated during the course of the study.

- Minor surgical procedures (i.e., mediport insertion), fine needle aspirates, or
core biopsies within 7 days prior to the first date of bevacizumab/placebo
therapy

- Patients who are pregnant or nursing
We found this trial at
201
sites
1201 Camino de Salud Northeast
Albuquerque, New Mexico 87131
(505) 272-4946
University of New Mexico Cancer Center It’s been 40 years since the New Mexico State...
1184
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Albuquerque, NM
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2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
1983
mi
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Jackson, MS
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524 South Park Street
Kalamazoo, Michigan 49007
(269) 341-7654
Bronson Methodist Hospital Our healthcare system serves patients and families throughout southwest Michigan and northern...
1816
mi
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Kalamazoo, MI
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200 North Park Street
Kalamazoo, Michigan 49007
(269) 382-2500
West Michigan Cancer Center In 1994, Borgess Health Alliance and Bronson Healthcare Group opened the...
1814
mi
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Kalamazoo, MI
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1 Gustave L Levy Pl # 271
New York, New York 10029
 (212) 241-6500
Mount Sinai Med Ctr Founded in 1852, The Mount Sinai Hospital is a 1,171-bed, tertiary-care...
2401
mi
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New York, NY
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3900 W Avera Drive
Sioux Falls, South Dakota 57108
(605) 322-4700
Avera Cancer Institute Avera, the health ministry of the Benedictine and Presentation Sisters, is a...
1264
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Sioux Falls, SD
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1200 Old York Road
Abington, Pennsylvania 19001
(215) 481–2000
Abington Memorial Hospital Abington Memorial Hospital (AMH) is a 665-bed, regional referral center and teaching...
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Abington, PA
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2042
mi
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Akron, OH
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Albany, New York 12208
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mi
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Albany, NY
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Albuquerque, New Mexico 87106
1184
mi
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Albuquerque, NM
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Albuquerque, New Mexico 87131
(505) 277-0111
University of New Mexico Founded in 1889 as New Mexico’s flagship institution, the University of...
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Albuquerque, NM
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Allentown, Pennsylvania 18103
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Allentown, PA
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2300
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Augusta, GA
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13001 E. 17th Pl.
Aurora, Colorado 80045
303-724-5000
University of Colorado Cancer Center - Anschutz Cancer Pavilion The University of Colorado Denver |...
1026
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Aurora, CO
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1501 S Potomac St
Aurora, Colorado 80012
(303) 695-2600
Medical Center of Aurora At The Medical Center of Aurora and Centennial Medical Plaza patients...
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2332
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Baltimore, MD
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6701 N Charles St
Baltimore, Maryland 21204
(443) 849-2000
Greater Baltimore Medical Center The 255-bed medical center (acute and sub-acute care) is located on...
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22 South Greene Street
Baltimore, Maryland 21201
410-328-7904
University of Maryland Greenebaum Cancer Center The University of Maryland Marlene and Stewart Greenebaum Cancer...
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401 North Broadway
Baltimore, Maryland 21287
410-955-5000
Johns Hopkins University-Sidney Kimmel Cancer Center The name Johns Hopkins has become synonymous with excellence...
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265 Fremont St
Battle Creek, Michigan 49017
(269) 245-8166
Bronson Battle Creek As a proud member of the Battle Creek community, we believe everyone...
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8901 Rockville Pike
Bethesda, Maryland 20889
(301) 295-4000
Walter Reed National Military Medical Center The Walter Reed National Military Medical Center is one...
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Big Rapids, Michigan 49307
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Big Rapids, MI
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1100 Balsam Ave
Boulder, Colorado 80304
(303) 440-2273
Boulder Community Hospital Founded in 1922 as a community-owned and operated not-for-profit hospital, Boulder Community...
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Boulder, CO
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Brooklyn, NY
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Burlington, Massachusetts 01805
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Burlington, Vermont 05405
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201 E Nicollet Blvd
Burnsville, Minnesota 55337
(952) 892-2000
Fairview Ridges Hospital Fairview Ridges Hospital is a 150-bed, Level III Trauma Care facility, offering...
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Camden, NJ
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Charlotte, North Carolina 28204
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Charlotte, North Carolina 28204
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Charlotte, NC
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5841 S Maryland Ave
Chicago, Illinois 60637
1-773-702-6180
University of Chicago Comprehensive Cancer Center The University of Chicago Comprehensive Cancer Center (UCCCC) is...
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Chicago, IL
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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303 East Superior Street
Chicago, Illinois 60611
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Chicago, IL
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2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
1967
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Cincinnati, OH
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10900 Euclid Ave
Cleveland, Ohio 44106
216-368-2000
Case Western Reserve Univ Continually ranked among America's best colleges, Case Western Reserve University has...
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Cleveland, OH
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2500 Metrohealth Dr
Cleveland, Ohio 44109
(216) 778-7800
MetroHealth Med Ctr The MetroHealth System is one of the largest, most comprehensive health care...
2020
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Cleveland, OH
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18101 Lorain Avenue
Cleveland, Ohio 44111
216.476.7000
Cleveland Clinic Cancer Center at Fairview Hospital Fairview Hospital is a 488-bed hospital located at...
2017
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Cleveland, OH
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
2016
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Cleveland, OH
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12495 University Ave
Clive, Iowa 50325
(515) 358-9700
Mercy Cancer Center - West Lakes When it comes to cancer care, there
1455
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Clive, IA
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1455
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Clive, IA
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6001 E Woodmen Rd
Colorado Springs, Colorado 80923
(719) 776-5000
Penrose-Saint Francis Healthcare Founded by the Sisters of St. Francis and the Sisters of Charity,...
1067
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Colorado Springs, CO
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1831 Fifth Avenue
Columbus, Georgia 31904
(706) 320-8700
John B. Amos Cancer Center The John B. Amos Cancer Center located in Columbus, Georgia,...
2205
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Columbus, GA
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2006
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Columbus, OH
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3535 Olentangy River Rd
Columbus, Ohio 43214
(614) 566-5000
Riverside Methodist Hospital Serving central Ohio since 1892, Riverside Methodist Hospital is consistently ranked one...
2004
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Columbus, OH
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Concord, California 94520
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Concord, CA
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Concord, North Carolina 28025
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Concord, NC
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4050 Coon Rapids Blvd NW
Coon Rapids, Minnesota 55433
(763) 236-6000
Mercy Hospital Mercy Hospital, located in Coon Rapids, Minnesota, is a 271-bed non-profit hospital that...
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Coon Rapids, MN
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Dallas, Texas 75235
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Dallas, TX
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Dallas, Texas 75390
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Dallas, TX
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Dallas, TX
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5201 Harry Hines Blvd
Dallas, Texas 75235
(214) 590-8000
Parkland Memorial Hospital As our community's public health system, Parkland is the foundation for a...
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100 North Academy Avenue
Danville, Pennsylvania 17822
570-271-6211
Geisinger Medical Center Since 1915, Geisinger Medical Center has been known as the region’s resource...
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1720 S. Bellaire Street Suite 701
Denver, Colorado 80222
(303) 777-2663
Colorado Cancer Research Program CCOP Colorado Cancer Research Program (CCRP) was established in 1983 and...
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1835 Franklin St
Denver, Colorado 80218
(303) 837-7111
Exempla Saint Joseph Hospital Founded in 1873 by the Sisters of Charity of Leavenworth, Saint...
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Denver, CO
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2525 S Downing St
Denver, Colorado 80210
(303) 778-1955
Porter Adventist Hospital Founded in 1930, Porter Adventist Hospital has provided people throughout Denver and...
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4567 E 9th Ave
Denver, Colorado 80220
(303) 320-2121
Rose Medical Center Well known as a Denver institution and a 9th Avenue landmark for...
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1021
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Denver, CO
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1111 6th Ave
Des Moines, Iowa 50314
(515) 247-3121
Mercy Medical Center - Des Moines Mercy Medical Center
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Des Moines, IA
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Des Moines, IA
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Des Moines, IA
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1200 Pleasant St
Des Moines, Iowa 50309
(515) 241-6212
Iowa Methodist Medical Center Iowa Methodist Medical Center was established in 1901 in a single...
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3800 Park Nicollet Blvd
Des Moines, Iowa 50309
(952) 993-1516
Iowa Oncology Research Association CCOP The Iowa Oncology Research Association (IORA) was established by a...
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Des Moines, IA
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700 E University Ave
Des Moines, Iowa 50316
(515) 263-5612
Iowa Lutheran Hospital Iowa Lutheran Hospital has a long history of serving the Des Moines...
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4160 John R St #2122
Detroit, Michigan 48201
(313) 833-1785
Wayne State University/Karmanos Cancer Institute Karmanos is based in southeast Michigan, in midtown Detroit, and...
1932
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Detroit, MI
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Durham, NC
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6401 France Ave S
Edina, Minnesota 55435
(952) 924-5000
Fairview Southdale Hospital Fairview Health Services is an award-winning nonprofit health care system based in...
1390
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Edina, MN
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303 S Nappanee St
Elkhart, Indiana 46514
(574) 296-3200
Elkhart Clinic, LLC Informed participation in the management of your health care maximizes your Elkhart...
1815
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Elkhart, IN
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600 East Blvd
Elkhart, Indiana 46515
(574) 294-2621
Elkhart General Hospital For over 100 years, the highly skilled professionals of Elkhart General Hospital...
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Elkhart, IN
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500 Arcade Blvd, Ste 240
Elkhart, Indiana 46514
574-389-0414
Michiana Hematology-Oncology The Advanced Center for Cancer Care in Plymouth is part of the Cancer...
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Elkhart, IN
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Elkton, Maryland 21921
2353
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Elkton, MD
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501 E. Hampden Ave.
Englewood, Colorado 80113
303-788-5000
1024
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Englewood, CO
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Englewood, Colorado 80110
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Englewood, CO
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1659
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Fort Worth, TX
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550 Osborne Rd NE
Fridley, Minnesota 55432
(763) 236-5000
Unity Hospital Unity Hospital is one of the Twin Cities
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Fridley, MN
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Grand Junction, Colorado 81502
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Grand Junction, CO
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Grand Rapids, Michigan 49503
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Grand Rapids, MI
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25 Michigan St. NE, Suite 3100
Grand Rapids, Michigan 49503
(616) 391-1230
Grand Rapids Clinical Oncology Program GRCOP initially formed to develop community cancer patient management guidelines....
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Grand Rapids, MI
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100 Michigan St NE
Grand Rapids, Michigan 49503
(616) 391-1774
Spectrum Health at Butterworth Campus Butterworth Hospital is one of four facilities that make up...
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Grand Rapids, MI
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1801 16th St
Greeley, Colorado 80631
(970) 352-4121
North Colorado Medical Center NCMC is a fully accredited, private, non-profit facility licensed to operate...
1005
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Greeley, CO
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80 Seymour St
Hartford, Connecticut 6102
(860) 545-5000
The Hartford Hospital Hartford Hospital is the major teaching hospital affiliated with the University of...
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Hartford, CT
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2303
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Hazleton, PA
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500 University Dr
Hershey, Pennsylvania 17033
(717) 531-6955
Penn State Milton S. Hershey Medical Center Penn State Milton S. Hershey Medical Center, Penn...
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Hershey, PA
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1721
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Hinsdale, IL
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Houston, Texas 77030
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Houston, TX
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1095 Minnesota 15
Hutchinson, Minnesota 55350
(320) 234-5000
Hutchinson Area Health Care Hutchinson Health is a team of medical professionals and support staff...
1341
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Hutchinson, MN
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Indianapolis, Indiana 46237
1874
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Indianapolis, IN
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Indianapolis, Indiana 46260
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Indianapolis, IN
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Indianapolis, Indiana 46237
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Indianapolis, IN
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535 Barnhill Dr
Indianapolis, Indiana 46202
(888) 600-4822
Indiana University Melvin and Bren Simon Cancer Center At the IU Simon Cancer Center, more...
1867
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Indianapolis, IN
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1557
mi
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Iowa City, IA
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4500 San Pablo Rd S
Jacksonville, Florida 32224
(904) 953-2000
Mayo Clinic Florida Thousands of people come to Mayo Clinic in Jacksonville, Fla., annually for...
2462
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Jacksonville, FL
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1521 Gull Rd
Kalamazoo, Michigan 49048
269) 226-7000
Borgess Medical Center At Borgess, healing is our calling. This is the place where people...
1818
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Kalamazoo, MI
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Kansas City, Kansas 66160
1503
mi
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Kansas City, KS
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3535 Southern Blvd
Kettering, Ohio 45429
(937) 298-4331
Kettering Medical Center Our flagship hospital, Kettering Medical Center, stands proudly in Kettering, Ohio. From...
1963
mi
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Kettering, OH
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3500 S. Lafountain Street
Kokomo, Indiana 46902
765-453-0702
Community Howard Regional Health Selecting quality health care services for yourself, a relative or friend...
1846
mi
from 98109
Kokomo, IN
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3855 Health Sciences Dr,
La Jolla, California 92093
(858) 822-6100
UC San Diego Moores Cancer Center Established in 1978, UC San Diego Moores Cancer Center...
1055
mi
from 98109
La Jolla, CA
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La Porte, Indiana 46350
1783
mi
from 98109
La Porte, IN
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Lakewood, Colorado 80228
1015
mi
from 98109
Lakewood, CO
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Las Cruces, New Mexico 88011
1336
mi
from 98109
Las Cruces, NM
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