Postoperative Chemotherapy With or Without Bevacizumab for Patients With Stage II or III Rectal Cancer
Status: | Terminated |
---|---|
Conditions: | Colorectal Cancer, Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | February 2006 |
End Date: | April 2019 |
Intergroup Randomized Phase III Study of Postoperative Oxaliplatin, 5-Fluorouracil and Leucovorin vs Oxaliplatin, 5-Fluorouracil, Leucovorin and Bevacizumab for Patients With Stage II or III Rectal Cancer Receiving Pre-operative Chemoradiation
Drugs used in chemotherapy, such as oxaliplatin, leucovorin, and fluorouracil, 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. Giving more than one
drug (combination chemotherapy) together with bevacizumab after surgery may kill any tumor
cells that remain after surgery. It is not yet known whether oxaliplatin, leucovorin, and
fluorouracil is more effective with or without bevacizumab in treating rectal cancer. This
randomized phase III trial is studying combination chemotherapy to see how well it works
with or without bevacizumab in treating patients who have had surgery for stage II or stage
III rectal cancer.
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. Giving more than one
drug (combination chemotherapy) together with bevacizumab after surgery may kill any tumor
cells that remain after surgery. It is not yet known whether oxaliplatin, leucovorin, and
fluorouracil is more effective with or without bevacizumab in treating rectal cancer. This
randomized phase III trial is studying combination chemotherapy to see how well it works
with or without bevacizumab in treating patients who have had surgery for stage II or stage
III rectal cancer.
PRIMARY OBJECTIVES:
I. Compare the overall survival of patients who have undergone prior surgery and neoadjuvant
chemoradiotherapy for clinical stage II or III rectal cancer treated with adjuvant
oxaliplatin, leucovorin calcium, fluorouracil with vs without bevacizumab.
SECONDARY OBJECTIVES:
I. Evaluate tolerance of treatment, patterns of failure, and disease-free survival in
patients treated with these regimens.
II. Assess long-term rectal function using the Patient Bowel Function/Uniscale questionnaire
and the Functional Assessment of Cancer (FACT)-Diarrhea subscale in patients treated with
these regimens.
III. Validate the FACT-Diarrhea subscale.
IV. Assess long-term symptoms of oxaliplatin-related neurotoxicity using the
FACT/Gynecologic Oncology Group (GOG)-Neurotoxicity subscale in patients treated with these
regimens.
V. Correlate TS, DPD and TP expression (key targets for fluorouracil); retention of
chromosome 18q alleles and microsatellite instability (MSI) with TGFβ1RII mutation (markers
for fluorouracil efficacy); ERCC1, ERCC2, and XPF expression (participants in repair of
adducts from oxaliplatin); and p53 gene mutation and possibly other molecular markers
pertinent to vascular endothelial growth factor in tumor tissue specimens with treatment
efficacy in these patients.
VI. Correlate tumor molecular prognostic markers (chromosome 18q allelic loss and MSI) with
survival in patients treated with this regimen.
OUTLINE:
This is a randomized study. Patients are stratified according to Eastern Cooperative
Oncology Group (ECOG) performance status (0 vs 1), clinical staging (high risk [T3, N+, M0
or T4, any N, M0] vs low risk [T1-2, N+, M0 or T3, N0, M0]), prior pre-operative oxaliplatin
(yes vs no), and prior radiotherapy dose (40-50 Gy vs > 50-55.8 Gy). Patients are randomized
to 1 of 2 treatment arms in a 1:1 ratio.
ARM I: Patients receive oxaliplatin intravenously (IV) over 2 hours, leucovorin calcium IV
over 2 hours, and fluorouracil IV on day 1 followed by fluorouracil IV continuously over 46
hours on days 1 and 2. Treatment repeats every 2 weeks for up to 12 courses* in the absence
of disease progression or unacceptable toxicity.
ARM II: Patients receive bevacizumab** IV over 30-90 minutes on day 1. Patients also receive
oxaliplatin, leucovorin calcium, and fluorouracil as in arm I*.
[Note: *Patients who received prior neoadjuvant oxaliplatin including patients on protocol
NSABP-R-04 receive up to 9 courses of treatment followed by leucovorin calcium IV and
fluorouracil IV with (arm II) or without (arm I) bevacizumab for up to 3 courses.]
[Note: **Patients no longer receive bevacizumab as of 4/29/2009 when accrual was terminated
due to slow accrual for the study)]
Patients complete 10-15 minute questionnaires about bowel function at randomization, end of
treatment, 12 months post-treatment and then annually to 5 years post-treatment.
After completion of study treatment, patients are followed periodically for approximately 10
years.
PROJECTED ACCRUAL: 2100 patients
I. Compare the overall survival of patients who have undergone prior surgery and neoadjuvant
chemoradiotherapy for clinical stage II or III rectal cancer treated with adjuvant
oxaliplatin, leucovorin calcium, fluorouracil with vs without bevacizumab.
SECONDARY OBJECTIVES:
I. Evaluate tolerance of treatment, patterns of failure, and disease-free survival in
patients treated with these regimens.
II. Assess long-term rectal function using the Patient Bowel Function/Uniscale questionnaire
and the Functional Assessment of Cancer (FACT)-Diarrhea subscale in patients treated with
these regimens.
III. Validate the FACT-Diarrhea subscale.
IV. Assess long-term symptoms of oxaliplatin-related neurotoxicity using the
FACT/Gynecologic Oncology Group (GOG)-Neurotoxicity subscale in patients treated with these
regimens.
V. Correlate TS, DPD and TP expression (key targets for fluorouracil); retention of
chromosome 18q alleles and microsatellite instability (MSI) with TGFβ1RII mutation (markers
for fluorouracil efficacy); ERCC1, ERCC2, and XPF expression (participants in repair of
adducts from oxaliplatin); and p53 gene mutation and possibly other molecular markers
pertinent to vascular endothelial growth factor in tumor tissue specimens with treatment
efficacy in these patients.
VI. Correlate tumor molecular prognostic markers (chromosome 18q allelic loss and MSI) with
survival in patients treated with this regimen.
OUTLINE:
This is a randomized study. Patients are stratified according to Eastern Cooperative
Oncology Group (ECOG) performance status (0 vs 1), clinical staging (high risk [T3, N+, M0
or T4, any N, M0] vs low risk [T1-2, N+, M0 or T3, N0, M0]), prior pre-operative oxaliplatin
(yes vs no), and prior radiotherapy dose (40-50 Gy vs > 50-55.8 Gy). Patients are randomized
to 1 of 2 treatment arms in a 1:1 ratio.
ARM I: Patients receive oxaliplatin intravenously (IV) over 2 hours, leucovorin calcium IV
over 2 hours, and fluorouracil IV on day 1 followed by fluorouracil IV continuously over 46
hours on days 1 and 2. Treatment repeats every 2 weeks for up to 12 courses* in the absence
of disease progression or unacceptable toxicity.
ARM II: Patients receive bevacizumab** IV over 30-90 minutes on day 1. Patients also receive
oxaliplatin, leucovorin calcium, and fluorouracil as in arm I*.
[Note: *Patients who received prior neoadjuvant oxaliplatin including patients on protocol
NSABP-R-04 receive up to 9 courses of treatment followed by leucovorin calcium IV and
fluorouracil IV with (arm II) or without (arm I) bevacizumab for up to 3 courses.]
[Note: **Patients no longer receive bevacizumab as of 4/29/2009 when accrual was terminated
due to slow accrual for the study)]
Patients complete 10-15 minute questionnaires about bowel function at randomization, end of
treatment, 12 months post-treatment and then annually to 5 years post-treatment.
After completion of study treatment, patients are followed periodically for approximately 10
years.
PROJECTED ACCRUAL: 2100 patients
Inclusion Criteria:
- Histologically confirmed adenocarcinoma of the rectum meeting 1 of the following
clinical (e.g., before neoadjuvant therapy) or pathologic staging criteria:
- T3, N+, M0
- T3, N0, M0
- T4, N0, M0
- Any T, N1-2, M0
- T4, N0-2, M0 disease must meet 1 of the following criteria:
- Clinically fixed tumor on rectal examination with tumor adherent to the pelvic
sidewall or sacrum
- Hydronephrosis on Computed Tomography (CT) scan or Intravenous Pyelogram (IVP)
- Ureteric or bladder invasion as documented by cystoscopy and cytology or biopsy
- Invasion into prostate
- Vaginal or uterine involvement
- Must have undergone complete tumor resection >= 28 days ago and able to begin
treatment by day 56
- Must have undergone concurrent neoadjuvant chemoradiotherapy*
- NOTE: *Neoadjuvant chemoradiotherapy received on protocol NSABP-R-04 allowed
provided it met these criteria
- Must have undergone prior radiotherapy at 40-55.8 Gy** AND received 1 of the
following chemotherapy regimens:
- Continuous infusion of fluorouracil with or without oxaliplatin; fluorouracil
and leucovorin calcium
- Capecitabine with or without oxaliplatin; capecitabine with or without
oxaliplatin OR a continuous infusion of fluorouracil with or without oxaliplatin
received on protocol NSABP-R-04
- NOTE: **Intensity-modulated radiotherapy allowed
- ECOG performance status 0-1
- Platelet count >= 100,000/mm^3
- Absolute granulocyte count >= 1,500/mm^3
- Bilirubin normal (unless chronic grade 1 bilirubin elevation due to Gilbert's disease
or similar syndrome due to slow conjugation of bilirubin)
- Alkaline phosphatase (AP) < 2.5 times upper limit of normal (ULN) and aspartate
aminotransferase (AST) < 1.5 times ULN
- Hepatitis B and C negative (for patients with AP > normal) unless previously
vaccinated
- Serum creatinine =< 1.5 times ULN
- Urine protein:creatinine (UPC) ratio < 1.0 OR urine protein < 1 g on 24-hour urine
collection
- International Normalized Ratio (INR) =< 1.5
- INR > 1.5 allowed provided patient is on full-dose anticoagulants AND meets all of
the following criteria:
- In-range INR (i.e., between 2 and 3) on a stable dose of warfarin or low
molecular weight heparin
- No active bleeding or pathological condition that is associated with a high risk
of bleeding
- Negative pregnancy test
- Fertile patients must use effective contraception during and for at least 3 months
after study treatment
- No other previous or concurrent malignancy except nonmelanoma skin cancer, breast
cancer in situ, carcinoma in situ of the cervix, or previously treated nonpelvic
cancer that has been disease-free for > 5 years
- Patients with a history of breast cancer (without evidence of disease) who remain on
hormonal therapy for > 5 years are eligible
- Patients with a history of hypertension must have blood pressure < 150/90 mm Hg AND
be on a stable regimen of antihypertensive therapy
- No other prior chemotherapy or pelvic radiotherapy except as neoadjuvant treatment
for current diagnosis of rectal cancer
- Concurrent participation on protocol NSABP-R-04 allowed
Exclusion Criteria:
- Pregnant or nursing
- Evidence of metastatic disease on the surgical/intraoperative examination
- Evidence of metastatic disease confirmed by CT scan, Magnetic resonance imaging
(MRI), or ultrasound of the liver or chest CT scan or chest x-ray within the past 6
months
- Evidence of tumor outside of the pelvis, including liver metastases, peritoneal
seeding, or metastatic inguinal lymphadenopathy
- Concurrent major surgery
- Active bleeding not related to the primary rectal tumor within the past 6 months
- Active inflammatory bowel disease or other serious medical illness which might limit
the ability of the patient to receive protocol therapy
- Active gastroduodenal ulcer determined by endoscopy
- Serious or nonhealing wound, skin ulcer, or bone fracture
- Clinically significant peripheral sensory or motor neuropathy >= grade 2
- Nonmalignant systemic disease (e.g., cardiovascular, renal, or hepatic) that would
preclude study treatment including, but not limited to, any of the following:
- New York Heart Association class III or IV congestive heart failure
- Concurrent symptomatic arrhythmia
- Transient ischemic attack or cerebrovascular accident
- Arterial thromboembolic event, unstable angina, or myocardial infarction within the
past 12 months
- Significant peripheral vascular disease
- Psychiatric or addictive disorders or other conditions that, in the opinion of the
investigator, would preclude study requirements
- Significant traumatic injury within the past 28 days
- Known allergy to platinum compounds
- Prior invasive procedure, including either of the following:
- Major surgical procedure or open biopsy within the past 28 days
- Core biopsy or other minor procedure, except placement of a vascular access
device, within the past 7 days
We found this trial at
601
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1201 Camino de Salud Northeast
Albuquerque, New Mexico 87131
Albuquerque, New Mexico 87131
(505) 272-4946
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Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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University of Vermont The University of Vermont combines faculty-student relationships most commonly found in a...
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University of Chicago One of the world's premier academic and research institutions, the University of...
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Hurley Medical Center From its founding in 1908, Hurley Medical Center has devoted itself to...
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Holy Cross Hospital While spirituality plays an essential role in the way that we minister...
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1800 West Charleston Boulevard
Las Vegas, Nevada 89102
Las Vegas, Nevada 89102
(702) 383-2000
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University Medical Center of Southern Nevada University Medical Center is dedicated to providing the highest...
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Medical Center of Central Georgia Navicent Health is a designated Level I Trauma Center and...
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Vanderbilt-Ingram Cancer Center The Vanderbilt-Ingram Cancer Center, located in Nashville, Tenn., brings together the clinical...
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University of Pittsburgh The University of Pittsburgh is a state-related research university, founded as the...
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4805 Northeast Glisan Street
Portland, Oregon 97213
Portland, Oregon 97213
(503) 215-1111
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Providence Portland Medical Center We strive to give those we serve exceptional, compassionate health care...
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University of Rochester The University of Rochester is one of the country's top-tier research universities....
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2279 45th Street
Sacramento, California 95817
Sacramento, California 95817
(916) 734-5800
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University of California Davis Cancer Center At UC Davis Comprehensive Cancer Center, specialized teams of...
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601 South Sherman Street
Spokane, Washington 99202
Spokane, Washington 99202
(509) 228-1000
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Cancer Care Northwest - Spokane South Cancer Care Northwest is the Inland Northwest’s premier cancer...
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Abington Memorial Hospital Abington Memorial Hospital (AMH) is a 665-bed, regional referral center and teaching...
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Bixby Medical Center ProMedica's Mission is to improve your health and well-being. Which is why,...
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Lehigh Valley Hospital At Lehigh Valley Health Network, we continually go the extra mile to...
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McFarland Clinic PC-William R Bliss Cancer Center The William R. Bliss Cancer Center at Mary...
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Saint Joseph Mercy Hospital St. Joseph Mercy Ann Arbor Hospital is a 537-bed teaching hospital...
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Michigan Cancer Research Consortium Community Clinical Oncology Program The Community Clinical Oncology Program (CCOP) is...
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5665 Peachtree Dunwoody Rd NE
Atlanta, Georgia 30342
Atlanta, Georgia 30342
(678) 843-7001
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Saint Joseph's Hospital of Atlanta Founded by the Sisters of Mercy in 1880, Saint Joseph
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Piedmont Hospital For more than a century, Piedmont Healthcare has been a recognized leader in...
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Northside Hospital Northside Hospital-Atlanta (in Sandy Springs) opened in 1970. The original facility had 250...
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Georgia Regents University Georgia Regents University, home of the Medical College of Georgia, is one...
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Medical Center of Aurora At The Medical Center of Aurora and Centennial Medical Plaza patients...
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Rush - Copley Medical Center Rush-Copley is proud to be the leading provider of health...
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Eastern Maine Medical Center Located in Bangor, Eastern Maine Medical Center (EMMC) serves communities throughout...
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Bronson Battle Creek As a proud member of the Battle Creek community, we believe everyone...
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1600 Albany Street
Beech Grove, Indiana 46107
Beech Grove, Indiana 46107
(317) 787–3311
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Mary Rutan Hospital The hospital was endowed by the sale of a farm in Ridgeway...
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Sanford Clinic North-Bemidgi Sanford Health is a voluntary, not-for-profit health care organization. Through its entities,...
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Montana Cancer Consortium CCOP The Montana Cancer Consortium is a nonprofit organization whose mission is...
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Billings Clinic Based in Billings, Montana, Billings Clinic is a community-governed health care organization consisting...
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Saint Vincent Healthcare The Sisters of Charity of Leavenworth, Kansas, founded St. Vincent Healthcare in...
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Bismarck Cancer Center The Bismarck Cancer Center (BCC) is a joint venture between Sanford Health...
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Mid Dakota Clinic, PC We're your family clinic, with the doctors you know and trust...
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Saint Alexius Medical Center St. Alexius Medical Center is a 306-bed, full-service, acute care medical...
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Sanford Bismarck Medical Center Whether your stay in our hospital is one day for same...
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Saint Luke's Mountain States Tumor Institute For more than 100 years, St. Luke
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Saint Alphonsus Regional Medical Center Saint Alphonsus Health System is a four-hospital regional, faith-based Catholic...
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Boulder Community Hospital Founded in 1922 as a community-owned and operated not-for-profit hospital, Boulder Community...
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Toledo Clinic Cancer Centers-Bowling Green Our doctors evaluate and make recommendations regarding cancer treatment for...
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Bozeman Deaconess Cancer Center Bozeman Deaconess Cancer Center provides the latest cancer technologies and treatment...
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Bozeman Deaconess Hospital Bozeman Deaconess Hospital is a Joint Commission certified, licensed Level III trauma...
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Albert Einstein College of Medicine The Albert Einstein College of Medicine of Yeshiva University is...
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Bryn Mawr Hospital Bryn Mawr Hospital, a nationally recognized community teaching hospital, is conveniently located...
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Fairview Ridges Hospital Fairview Ridges Hospital is a 150-bed, Level III Trauma Care facility, offering...
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400 South Clark Street
Butte, Montana 59701
Butte, Montana 59701
406-723-2500
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Saint James Community Hospital and Cancer Treatment Center St. James Healthcare has played an important...
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Aultman Health Foundation The Aultman Foundation will raise and administer funds in order to support...
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Saint Francis Medical Center Saint Francis Medical Center is a 282-bed facility serving more than...
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Memorial Hospital Memorial Hospital is a vital force in establishing and maintaining the well-being of...
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East Bay Radiation Oncology Center East Bay Radiation Oncology Center offers superior medical and technical...
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20055 Lake Chabot Rd #130
Castro Valley, California 94546
Castro Valley, California 94546
(510) 888-0657
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Valley Medical Oncology Consultants - Castro Valley Valley Medical Oncology Consultants (VMOC) has been helping...
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Sandra L. Maxwell Cancer Center The Huntsman-Intermountain Cancer Center at Valley View Medical Center in...
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