Pixantrone Dimaleate in Treating Patients With HER2-Negative Metastatic Breast Cancer
Status: | Completed |
---|---|
Conditions: | Breast Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 5/10/2018 |
Start Date: | May 2010 |
End Date: | November 15, 2014 |
Randomized Phase II Study of Two Doses of Pixantrone in Patients With Metastatic Breast Cancer
RATIONALE: Drugs used in chemotherapy, such as pixantrone dimaleate, work in different ways
to stop the growth of tumor cells, either by killing the cells or by stopping them from
dividing. Giving pixantrone dimaleate in different ways may kill more tumor cells.
PURPOSE: This randomized phase II trial is studying how well pixantrone dimaleate works in
treating patients with HER2-negative metastatic breast cancer.
to stop the growth of tumor cells, either by killing the cells or by stopping them from
dividing. Giving pixantrone dimaleate in different ways may kill more tumor cells.
PURPOSE: This randomized phase II trial is studying how well pixantrone dimaleate works in
treating patients with HER2-negative metastatic breast cancer.
OBJECTIVES:
Primary
- To assess the proportion of confirmed tumor responses at each dose level of pixantrone
Secondary
- To describe the distribution of progression-free survival (PFS) times of patients
receiving pixantrone
- To assess the 6-month PFS rate in patients receiving each dose level of pixantrone
- To describe the overall survival distribution of patients receiving pixantrone
- To assess the adverse event profile of pixantrone in the treatment of patients with
metastatic breast cancer.
- To evaluate the quality of life and patient-reported symptoms of patients receiving the
study regimen
OUTLINE: This is a multicenter study. Patients are randomized according to prior doxorubicin
treatment ( yes vs no). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive pixantrone dimaleate IV over 1 hour on day 1. Treatment repeats
every 21 days for up to 12 courses in the absence of disease progression or unacceptable
toxicity.
- Arm II: Patients receive pixantrone dimaleate IV over 1 hour on days 1, 8, and 15.
Treatment repeats every 28 days for up to 12 courses in the absence of disease
progression or unacceptable toxicity.
Some patients undergo blood sample collection at baseline and periodically during study for
circulating tumor cells analysis by CellSearch System and mRNA isolation assays.
Patients complete quality-of-life questionnaires using the Linear Analogue Self Assessment
(LASA6) and the Patient-Reported Outcomes Version of the Common Terminology Criteria for
Adverse Events (PRO-CTCAE) at baseline and periodically during study.
After completion of study therapy, patients are followed up every 3-6 months for up to 5
years.
Primary
- To assess the proportion of confirmed tumor responses at each dose level of pixantrone
Secondary
- To describe the distribution of progression-free survival (PFS) times of patients
receiving pixantrone
- To assess the 6-month PFS rate in patients receiving each dose level of pixantrone
- To describe the overall survival distribution of patients receiving pixantrone
- To assess the adverse event profile of pixantrone in the treatment of patients with
metastatic breast cancer.
- To evaluate the quality of life and patient-reported symptoms of patients receiving the
study regimen
OUTLINE: This is a multicenter study. Patients are randomized according to prior doxorubicin
treatment ( yes vs no). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive pixantrone dimaleate IV over 1 hour on day 1. Treatment repeats
every 21 days for up to 12 courses in the absence of disease progression or unacceptable
toxicity.
- Arm II: Patients receive pixantrone dimaleate IV over 1 hour on days 1, 8, and 15.
Treatment repeats every 28 days for up to 12 courses in the absence of disease
progression or unacceptable toxicity.
Some patients undergo blood sample collection at baseline and periodically during study for
circulating tumor cells analysis by CellSearch System and mRNA isolation assays.
Patients complete quality-of-life questionnaires using the Linear Analogue Self Assessment
(LASA6) and the Patient-Reported Outcomes Version of the Common Terminology Criteria for
Adverse Events (PRO-CTCAE) at baseline and periodically during study.
After completion of study therapy, patients are followed up every 3-6 months for up to 5
years.
Registration and Randomization - Inclusion Criteria
1. Women or men
2. ≥18 years of age
3. Histologically or cytologically confirmed adenocarcinoma of the breast and clinical
evidence of metastatic breast cancer.
4. Pre-treatment requirements:
4.1. Must have been previously treated in neoadjuvant, adjuvant or metastatic setting
with anthracycline and/or taxane.
4.2. Must have received 2-3 prior chemotherapy treatment regimens NOTE: If NO prior
(neo)adjuvant chemotherapy, patient must have received a minimum of 2 prior
chemotherapy regimens in the metastatic setting.
4.2.1 NOTE: If prior (neo)adjuvant chemotherapy HAS been given, patient must have
received at least 1 prior chemotherapy regimen in the metastatic setting.
4.3. Prior hormonal therapy allowed in the neo-adjuvant, adjuvant, or metastatic
setting.
Unlimited prior hormonal therapy is allowed.
5. Patients must have measurable disease as defined in the protocol.
6. Negative pregnancy test done ≤7 days prior to registration, for women of childbearing
potential only.
7. The following laboratory values obtained ≤15 days prior to registration.
7.1 Hemoglobin ≥10.0g/dL
7.2 ANC ≥1500/mm^3
7.3 Platelet count ≥100,000/mL
7.4 Total bilirubin ≤1.5 x ULN)
7.5 SGOT (AST) and SGPT (ALT) ≤5 x ULN
7.6 Serum creatinine ≤1.5 x ULN
8. LVEF ≥50% and EKG within institutional normal limits completed ≤22 days prior to
registration.
9. ECOG Performance Status (PS) of 0, 1 or 2.
10. Life expectancy >3 months
11. Ability to complete questionnaire(s) by themselves or with assistance.
12. Patient has provided written informed consent
13. Willingness to return to NCCTG enrolling institution for follow-up.
Registration and Randomization - Exclusion Criteria
1. Any of the following because this study involves an investigational agent whose
genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are
unknown.
1.1 Pregnant women
1.2 Nursing women
1.3 Men or women of childbearing potential who are unwilling to employ adequate
contraception (as determined by the treating physician)
2. Stage III or IV invasive cancer (other than breast cancer) in ≤3 years prior to
registration (with the exception of non-melanoma skin cancer).
3. HER2 positive breast cancer (3+ by IHC or FISH amplified) breast cancer by ASCO/CAP
guidelines
4. Has already received lifetime cumulative treatment with doxorubicin equivalent to >400
mg/m2.
5. >3 prior chemotherapy regimens for breast cancer.
5.1 NOTE: This number includes (neo)adjuvant chemotherapy, if given. If (neo)adjuvant
chemotherapy HAS been given it counts as one (1) regimen.
6. Major surgery, chemotherapy, or immunologic therapy ≤3 weeks prior to registration.
6.1 NOTE: If patient has received prior treatment with bevacizumab, treatment on this
trial should not begin until ≥4 weeks after the last dose of bevacizumab.
7. Radiotherapy ≤4 weeks prior to registration, except if to a non-target lesion only.
7.1 Prior radiation to a target lesion is permitted only if there has been clear
progression of the lesion since radiation was completed.
7.2 If patient receives single dose radiation for palliation or radiation to
non-target lesion, they may immediately proceed to registration without waiting.
7.3 Acute adverse events from radiation must have resolved to ≤Grade 1 (according to
current version of NCI CTCAE).
8. Evidence of active brain metastasis including leptomeningeal involvement.
8.1 CNS metastasis controlled by prior surgery and/or radiotherapy is allowed. To be
considered controlled, there must be at least 2 months of no symptoms or evidence of
progression prior to study entry and corticosteroid therapy given to control brain
edema must have been discontinued.
9. Uncontrolled hypertension (blood pressure [BP] >160/90mmHg on ≥2 occasions at least 5
minutes apart). (Patients who have recently started or adjusted anti-hypertensive
medications are eligible providing that BP is <140/90mmHg on any new regimen for ≥3
different observations in ≥14 days.).
10. Clinically significant cardiovascular or cerebrovascular disease, including any
history of the following at any time prior to registration:
10.1 Myocardial infarction
10.2 Unstable angina pectoris
10.3 New York Heart Association (NYHA) Class II or greater congestive heart failure
10.4. Uncontrolled or clinically significant cardiac arrhythmia (patients with
controlled atrial fibrillation are eligible)
11. Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection or psychiatric illness/social situations that would limit compliance with
study requirements.
12. Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment
of the investigator, would make the patient inappropriate for entry into this study or
interfere significantly with the proper assessment of safety and toxicity of the
prescribed regimens.
13. History of allergy or hypersensitivity to drug product excipients or agents chemically
similar to pixantrone.
14. Currently receiving treatment in a different clinical study in which investigational
procedures are performed or investigational therapies are administered.
14.1 Patient may not enroll in such clinical trials while participating in this study.
Exception may be granted for trials related to symptom management (Cancer Control) which do
not employ hormonal treatments or treatments that may block the path of the targeted agents
used in this trial.
We found this trial at
232
sites
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1201 Camino de Salud Northeast
Albuquerque, New Mexico 87131
Albuquerque, New Mexico 87131
(505) 272-4946
University of New Mexico Cancer Center It’s been 40 years since the New Mexico State...
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3535 Olentangy River Road
Columbus, Ohio 43214
Columbus, Ohio 43214
(614) 566-5000
Riverside Methodist Hospital Cancer Care Serving central Ohio since 1892, Riverside Methodist is consistently ranked...
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Hurley Medical Center From its founding in 1908, Hurley Medical Center has devoted itself to...
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1920 Libal Street
Green Bay, Wisconsin 54307
Green Bay, Wisconsin 54307
(920) 433-8889
St. Vincent Hospital Regional Cancer Center Our group of 19 oncologists, including the region's only...
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19229 Mack Ave
Grosse Pointe Woods, Michigan 48236
Grosse Pointe Woods, Michigan 48236
(866) 246-4673
Van Elslander Cancer Center at St. John Hospital and Medical Center We built the Van...
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Cancer Research Center of Hawaii The University of Hawaii Cancer Center is the only National...
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Hickman Cancer Center at Bixby Medical Center At ProMedica Bixby Hospital, we
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McFarland Clinic, PC It has been over 65 years since the founders of McFarland Clinic...
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5301 East Huron River Drive
Ann Arbor, Michigan 48106
Ann Arbor, Michigan 48106
1.877.590.5995
CCOP - Michigan Cancer Research Consortium The Community Clinical Oncology Program (CCOP) is a comprehensive...
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Saint Joseph Mercy Cancer Center Saint Joseph Mercy Health System is one of Michigan's most...
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8111 South Emerson Avenue
Beech Grove, Indiana 46237
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(317) 528-5000
St. Francis Hospital and Health Centers - Beech Grove Campus A trusted leader in providing...
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Mary Rutan Hospital The hospital was endowed by the sale of a farm in Ridgeway...
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MeritCare Bemidji Sanford Health is an integrated health system headquartered in the Dakotas and is...
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1101 N 27th St # 201
Billings, Montana 59101
Billings, Montana 59101
(406) 237-3585
St. Vincent Healthcare Cancer Care Services The Sisters of Charity of Leavenworth, Kansas, founded St....
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2900 12th Ave N Ste 160W
Billings, Montana 59101
Billings, Montana 59101
(406) 238-6290
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St. Joseph Medical Center Located in Bloomington, Illinois, OSF St. Joseph Medical Center is a...
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Wood County Oncology Center The Cancer Care Center at Wood County Hospital opened March 2014,...
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Fairview Ridges Hospital Fairview Ridges Hospital is a 150-bed, Level III Trauma Care facility, offering...
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Rocky Mountain Oncology Rocky Mountain Oncology Center is a spacious, comfortable, state-of-the-art 19,000 square foot...
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701 10th St SE
Cedar Rapids, Iowa 52403
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(319) 365-4673
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Cedar Rapids Oncology Associates Oncology Associates at Mercy Medical Center in Cedar Rapids (also known...
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Adena Regional Medical Center Since 1895, Adena Health System has remained focused on its commitment...
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9280 SE Sunnybrook Blvd #100
Clackamas, Oregon 97015
Clackamas, Oregon 97015
(503) 513-3300
Clackamas Radiation Oncology Center State-of-the-art technology and compassionate care come together at Clackamas Radiation Oncology...
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Mercy Cancer Center - West Lakes When it comes to cancer care, there
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Mount Carmel Health - West Hospital Located near downtown Columbus, Mount Carmel West is the...
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CCOP - Columbus As one of the original 20 CCOPs, the Columbus Community Clinical Oncology...
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11850 Blackfoot St. NW
Suite 130
Coon Rapids, Minnesota 55433
Coon Rapids, Minnesota 55433
763-236-0808
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Samaritan North Cancer Care Center At Good Samaritan Hospital (GSH), our licensed, board-certified staff uses...
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Grandview Hospital You'll feel like part of our family when you visit Grandview Medical Center...
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18101 Oakwood Blvd
Dearborn, Michigan 48124
Dearborn, Michigan 48124
(313) 593-8620
Oakwood Cancer Center at Oakwood Hospital and Medical Center In today's health care environment, a...
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Grady Memorial Hospital As the center of healthcare in Delaware County, Grady Memorial Hospital is...
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1221 Pleasant St Suite 100
Des Moines, Iowa 50309
Des Moines, Iowa 50309
(515) 282-2921
Medical Oncology and Hematology Associates at John Stoddard Cancer Center Iowa's first children's cancer center...
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411 Laurel St New Visions
Des Moines, Iowa 50314
Des Moines, Iowa 50314
(515) 247-3970
Medical Oncology and Hematology Associates at Mercy Cancer Center When it comes to cancer care,...
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1221 Pleasant St Suite 100
Des Moines, Iowa 50309
Des Moines, Iowa 50309
(515) 282-2921
Medical Oncology and Hematology Associates at John Stoddard Cancer Center Iowa's first children's cancer center...
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1221 Pleasant St
Des Moines, Iowa 50309
Des Moines, Iowa 50309
(515) 241-4141
John Stoddard Cancer Center at Iowa Methodist Medical Center Iowa's first children's cancer center opened...
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411 Laurel Street
Des Moines, Iowa 50314
Des Moines, Iowa 50314
(515) 247-3121
Mercy Cancer Center at Mercy Medical Center - Des Moines When it comes to cancer...
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300 East Locust St., Ste 350
Des Moines, Iowa 50309
Des Moines, Iowa 50309
(515) 244-7586
CCOP - Iowa Oncology Research Association The Iowa Oncology Research Association (IORA) was established by...
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Miller - Dwan Medical Center Essentia Health-Duluth, located in the Miller-Dwan building, is a 165-bed...
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CCOP - Duluth The Duluth CCOP, established and funded by the National Cancer Institute (NCI)...
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Fairview Southdale Hospital Fairview Health Services is an award-winning nonprofit health care system based in...
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Elkhart General Hospital For over 100 years, the highly skilled professionals of Elkhart General Hospital...
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Elkhart Clinic, LLC Informed participation in the management of your health care maximizes your Elkhart...
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Michiana Hematology-Oncology The Advanced Center for Cancer Care in Plymouth is part of the Cancer...
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Community Cancer Center When you have cancer, you might think first of treatments
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Hematology Oncology Center The Center for Hematology-Oncology was established in 1995 for the purpose of...
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Eureka Community Hospital Eureka Community Hospital, established in 1901, offers a wide range of emergency,...
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Illinois CancerCare - Eureka Illinois CancerCare is one of the largest private oncology and hematology...
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CCOP - MeritCare Hospital The Sanford Community Cancer Consortium is a "newly" formed CCOP, merging...
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Blanchard Valley Medical Associates Blanchard Valley Medical Associates was founded in 1974 by Dr. William...
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Genesys Hurley Cancer Institute Bringing the most advanced cancer treatment services, technologies and programs available...
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Front Range Cancer Specialists At Front Range Cancer Specialists, we are dedicated to providing quality...
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Poudre Valley Hospital A 270-bed regional medical center offering a wide array of treatments, surgeries,...
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550 Osborne Road
Fridley, Minnesota 55432
Fridley, Minnesota 55432
763-236-5000
Mercy and Unity Cancer Center at Unity Hospital Patients and their families are the heart...
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Galesburg Clinic, PC OSF Galesburg Clinic, located on the OSF St. Mary Medical Center campus,...
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Illinois CancerCare - Galesburg Illinois CancerCare, P.C. is a comprehensive practice treating patients withcancer andblood...
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1101 26th Street South
Great Falls, Montana 59405
Great Falls, Montana 59405
406.455.5000
Sletten Cancer Institute at Benefis Healthcare Benefis Hospitals has 516 beds at its two campuses...
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Green Bay, Wisconsin 54301
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Wayne Hospital Stretching back to our roots nearly 100 years ago, Wayne HealthCare has always...
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114 Woodland St, Hartford
Hartford, Connecticut 06105
Hartford, Connecticut 06105
(860) 714-4000
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Illinois CancerCare - Havana Illinois CancerCare, P.C. is a comprehensive practice treating patients withcancer andblood...
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Mason District Hospital Mason District Hospital is dedicated to providing superior healthcare close to home...
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Northern Montana Hospital Northern Montana Hospital (NMH) is the center of a comprehensive system of...
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St. Peter's Hospital Welcome to St. Peter’s Hospital, providing premier health care to a five–county...
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1301 Punchbowl Street
Honolulu, Hawaii 96813
Honolulu, Hawaii 96813
(808) 538-9011
Queen's Cancer Institute at Queen's Medical Center The Queen
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1319 Punahou St
Honolulu, Hawaii 96826
Honolulu, Hawaii 96826
(808) 983-6000
Kapiolani Medical Center for Women and Children Hawai‘i Pacific Health is an integrated health care...
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1329 Lusitana St. Ste 307
Honolulu, Hawaii 96813
Honolulu, Hawaii 96813
808.524.6115
OnCare Hawaii, Incorporated - Lusitana OnCare Hawaii is a Certified PROVENGE® Treatment Center. PROVENGE (sipuleucel-T)...
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