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A Phase III Clinical Trial Comparing Infusional 5-Fluorouracil (5-FU), Leucovorin, and Oxaliplatin (mFOLFOX6) Every Two Weeks With Bevacizumab to the Same Regimen Without Bevacizumab for the Treatment

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Trial Conditions
  • Colorectal Cancer
What is the purpose of this trial?

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin, and fluorouracil, work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as bevacizumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Bevacizumab may also stop the growth of tumor cells by stopping blood flow to the tumor. Giving chemotherapy together with bevacizumab may kill more tumor cells. It is not yet known whether treatment with oxaliplatin, leucovorin, and fluorouracil is more effective with or without bevacizumab in treating patients who have undergone surgery for colon cancer. PURPOSE: This randomized phase III trial is studying giving oxaliplatin, leucovorin, and fluorouracil together with bevacizumab to see how well it works compared to oxaliplatin, leucovorin, and fluorouracil alone in treating patients who have undergone surgery for stage II or stage III colon cancer.

Date & Status

Active, not recruiting

Who can Participate?


18 and older




- Histologically confirmed adenocarcinoma of the colon, meeting 1 of the following
stage criteria:

- Stage II disease (T3 or 4, N0, M0)

- Stage III disease (any T, N1 or 2, M0)

- No rectal tumors

- Distal extent of tumor ≥ 12 cm from the anal verge by endoscopy or surgical

- T4 tumors involving an adjacent structure (e.g., bladder, small intestine, or ovary)
by direct extension from the primary tumor are eligible provided the following
criteria are met:

- All or a portion of the adjacent structure was removed en bloc with the primary

- All grossly visible tumor was completely resected (i.e., curative resection) in
the opinion of the surgeon

- Margins of the resected specimen not involved with malignant cells by pathology

- Not planning local radiotherapy

- En bloc complete gross resection of tumor by open laparotomy or
laparoscopically-assisted colectomy within the past 29-50 days

- Two-stage surgical procedure allowed (i.e., decompressive colostomy followed by
definitive surgical resection)

- Patients with > 1 synchronous primary colon tumor are eligible

- Disease staging based on more advanced primary tumor

- No isolated, distant, or non-contiguous intra-abdominal metastases, even if resected



- 18 and over

Performance status

- Eastern Cooperative Oncology Group (ECOG) 0-1

Life expectancy

- At least 5 years


- Absolute granulocyte count ≥ 1,500/mm^3 (unless it represents an ethnic or racial
variation of normal)

- Postoperative platelet count ≥ 100,000/mm^3

- No significant bleeding unrelated to the primary colon tumor within the past 6 months


- Bilirubin ≤ upper limit of normal (ULN) (unless due to slow conjugation of bilirubin
caused by Gilbert's disease or a similar syndrome)

- Alkaline phosphatase < 2.5 times ULN

- Aspartate Aminotransferase (AST) < 1.5 times ULN

- If AST > normal, serologic testing for hepatitis B and C is required and the
results must be negative

- No Prothrombin Time and International Normalized Ratio (PT/INR) > 1.5 unless patient
is on full-dose anticoagulants AND the following criteria are met:

- INR 2-3 on a stable dose of warfarin

- No active bleeding

- No pathological condition associated with a high risk of bleeding

- No hepatic disease that would preclude study participation

- No history of viral hepatitis or other chronic liver disease


- Serum creatinine ≤ 1.5 times ULN

- Urine protein/creatinine ratio < 1.0 OR

- < 1 g of protein on 24-hour urine collection

- No renal disease that would preclude study participation


- No uncontrolled blood pressure, defined as > 150/90 mm Hg

- No cardiovascular disease that would preclude study participation, including any of
the following:

- New York Heart Association class III or IV myocardial disease

- Myocardial infarction within the past 12 months

- Unstable angina within the past 12 months

- Symptomatic arrhythmia

- No history of transient ischemic attack or cerebrovascular accident

- No arterial thrombotic event within the past 12 months

- No symptomatic peripheral vascular disease


- No other malignancy within the past 5 years except effectively treated squamous cell
or basal cell skin cancer, melanoma in situ, carcinoma in situ of the cervix, or
carcinoma in situ of the colon or rectum

- Must be at low risk of recurrence from any prior malignancy

- No serious or non-healing wound, skin ulcer, or bone fracture

- No active gastroduodenal ulcer by endoscopy

- No clinically significant peripheral neuropathy (i.e., neurosensory or neuromotor
toxicity ≥ grade 2)

- No significant traumatic injury within the past 4 weeks

- No other nonmalignant systemic disease that would preclude study participation

- No psychiatric or addictive disorder or other condition that would preclude study

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- Patients randomized to receive bevacizumab must use effective contraception
during and for 3 months after study treatment


Biologic therapy

- No concurrent prophylactic growth factors

- No concurrent biological response modifiers


- Not specified

Endocrine therapy

- Not specified


- See Disease Characteristics

- No prior radiotherapy for this malignancy

- No concurrent radiotherapy for this malignancy


- See Disease Characteristics

- Recovered from prior surgery

- More than 4 weeks since prior major surgery or open biopsy

- More than 7 days since prior core biopsy or other minor surgery (except placement of
a vascular access device)

- No concurrent or anticipated concurrent major surgery


- No prior systemic therapy for this malignancy

- No concurrent halogenated antiviral agents (e.g., sorivudine)

- No other concurrent investigational drugs

- No other concurrent antineoplastic agents

Gender: Both
Steward Physician(s)
  • Norman Wolmark, MD
  • St. Elizabeth's Medical Center - Active, not recruiting
  • Saint Anne's Hospital - Active, not recruiting
  • Norwood Hospital - Active, not recruiting
Trial Interventions
  • bevacizumab
  • 5-fluorouracil
  • leucovorin
  • oxaliplatin
Physician Researcher

Investigator Name:

  • Norman Wolmark, MD

Other Information

Sponsor: National Cancer Institute (NCI)
Phase: Phase 3
Trial ID: NCT00096278
Volunteers:  Not Accepting Healthy Volunteers

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