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Phase III Trial of Bevacizumab (NSC 704865), Oxaliplatin (NSC 266046), Fluorouracil and Leucovorin Versus Oxaliplatin, Fluorouracil and Leucovorin Versus Bevacizumab Alone in Previously Treated Patients With Advanced Colorectal Cancer

Phase 3
18 Years
Not Enrolling
Adenocarcinoma of the Colon, Adenocarcinoma of the Rectum, Recurrent Colon Cancer, Recurrent Rectal Cancer, Stage III Colon Cancer, Stage III Rectal Cancer, Stage IV Colon Cancer, Stage IV Rectal Cancer

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Trial Information

Phase III Trial of Bevacizumab (NSC 704865), Oxaliplatin (NSC 266046), Fluorouracil and Leucovorin Versus Oxaliplatin, Fluorouracil and Leucovorin Versus Bevacizumab Alone in Previously Treated Patients With Advanced Colorectal Cancer


I. Compare the response, time to progression, and overall survival of patients with
previously treated advanced or metastatic colorectal adenocarcinoma treated with
oxaliplatin, leucovorin calcium, and fluorouracil with or without bevacizumab versus
bevacizumab only. (Arm III closed to accrual as of 03/11/2003).

II. Compare the toxicity of these regimens in these patients.

OUTLINE: This is a randomized study. Patients are stratified according to ECOG performance
status (0 vs 1 or 2), and prior radiotherapy (yes vs no). Patients are randomized to 1 of 3
treatment arms.

Arm I: Patients receive bevacizumab IV over 30-90 minutes and oxaliplatin IV over 2 hours
on day 1. Patients also receive leucovorin calcium IV over 2 hours and fluorouracil (5-FU)
IV over 22 hours on days 1 and 2.

Arm II: Patients receive oxaliplatin, leucovorin calcium, and 5-FU as in arm I.

Arm III: Patients receive bevacizumab as in arm I. (Arm closed to accrual as of

Courses in all arms repeat every 2 weeks in the absence of disease progression or
unacceptable toxicity. Patients who achieve a complete response may receive 2 additional

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter.

Inclusion Criteria:

- Histologically confirmed adenocarcinoma of the colon or rectum

- Advanced or metastatic disease

- Must have received a fluoropyrimidine-based regimen and an irinotecan-based
regimen, either alone or in combination, for advanced disease

- May have relapsed within 6 months of adjuvant therapy with fluorouracil (5-FU)
(or combination 5-FU and irinotecan) and progressed after single-agent

- Measurable disease

- No known brain metastases

- Performance status - ECOG 0-2

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

- No history of thrombotic or hemorrhagic disorders

- Bilirubin no greater than 1.5 times upper limit of normal (ULN)

- AST no greater than 5 times ULN

- INR no greater than 1.5

- PTT no greater than ULN

- Creatinine no greater than 1.5 times ULN

- Proteinuria less than 1+ (i.e., 0 or trace)

- Protein less than 500 mg by 24-hour urine collection

- Proteinuria secondary to ureteral stents allowed

- No proteinuria secondary to nephropathy

- Controlled hypertension (less than 150/100 mm Hg) allowed if on a stable
antihypertensive regimen

- No prior myocardial infarction

- No uncontrolled congestive heart failure

- No unstable angina within the past 3 months

- No serious nonhealing wound, ulcer, or bone fracture

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No prior bevacizumab

- See Disease Characteristics

- Recovered from prior chemotherapy

- No prior oxaliplatin

- At least 2 weeks since prior radiotherapy and recovered

- At least 28 days since prior major surgical procedure

- At least 10 days since prior aspirin dose of more than 325 mg/day

- No concurrent therapeutic anticoagulation except prophylactic anticoagulation of
venous access device

- No concurrent antiplatelet agents (e.g., dipyridamole, ticlopidine, clopidogrel, or

- No concurrent oral cryotherapy on day 1 of oxaliplatin administration

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Time Frame:

From the date of entry on study, assessed up to 5 years

Safety Issue:


Principal Investigator

Bruce Giantonio

Investigator Role:

Principal Investigator

Investigator Affiliation:

Eastern Cooperative Oncology Group


United States: Food and Drug Administration

Study ID:




Start Date:

September 2001

Completion Date:

Related Keywords:

  • Adenocarcinoma of the Colon
  • Adenocarcinoma of the Rectum
  • Recurrent Colon Cancer
  • Recurrent Rectal Cancer
  • Stage III Colon Cancer
  • Stage III Rectal Cancer
  • Stage IV Colon Cancer
  • Stage IV Rectal Cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Colonic Neoplasms
  • Rectal Neoplasms
  • Colorectal Neoplasms



Eastern Cooperative Oncology Group Boston, Massachusetts  02215