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A Randomized Phase III Study Comparing 5-FU, Leucovorin and Oxaliplatin Versus 5-FU, Leucovorin, Oxaliplatin and Bevacizumab in Patients With Stage II Colon Cancer at High Risk for Recurrence to Deter

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Trial Conditions
  • Hereditary Non-polyposis Colon Cancer
  • Colorectal Cancer
  • Adenocarcinoma of the Colon
  • Colon Mucinous Adenocarcinoma
  • Colon Signet Ring Cell Adenocarcinoma
  • Stage II Colon Cancer
  • Mucinous Adenocarcinoma of the Colon
  • Signet Ring Adenocarcinoma of the Colon
  • Lynch Syndrome
  • Stage IIA Colon Cancer
  • Stage IIB Colon Cancer
  • Stage IIC Colon Cancer
What is the purpose of this trial?

This randomized phase III trial is studying oxaliplatin, leucovorin, fluorouracil, and bevacizumab to see how well they work compared to oxaliplatin, leucovorin, and fluorouracil or observation only in treating patients who have undergone surgery for stage II colon cancer. 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 combination chemotherapy together with bevacizumab after surgery may kill any remaining tumor cells or prevent the cancer from coming back. Sometimes, after surgery, the tumor may not need additional treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether giving combination chemotherapy together with bevacizumab is more effective than combination chemotherapy alone or observation only in treating colon cancer

Date & Status

Active, not recruiting

Who can Participate?


18 and older



Inclusion Criteria:

- Histologically confirmed adenocarcinoma of the colon

- Stage II disease (pT3, pT4a-b, N0, M0)

- At least 8 lymph nodes must have been evaluated

- Meets 1 of the following criteria:

- High risk for microsatellite instability (MSI) and loss of heterozygosity (LOH)
at chromosome 18q

- Microsatellite stable (MSS) with 18q LOH

- MSI-low grade (MSI-L) with 18q LOH

- Low risk for MSI and 18q LOH

- MSS with retention of 18q alleles

- MSI-L with retention of 18q alleles

- MSI-high grade (MSI-H) with retention of 18q alleles

- MSI-H without retention of 18q alleles

- MSI-H with 18q status uninformative

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

- If tumor is located beyond sigmoid colon and centimeter distance is unavailable,
include anatomic region of the colon (e.g., right colon, transverse colon,
hepatic flexure, descending colon, or cecum)

- Has undergone surgical resection of the tumor between the past 28-60 days

- Must have had a complete resection (R0 resection)

- No history of isolated, distant, or noncontiguous intra-abdominal metastases

- Patients with synchronous tumors or appendiceal tumors are ineligible

- Hereditary non-polyposis colorectal cancer allowed

- Paraffin-embedded tumor specimen (one with normal mucosa and one from the resection
tumor) available

- Performance status - ECOG 0-2

- Absolute granulocyte count ≥ 1,500/mm^3*

- Platelet count ≥ 100,000/mm^3*

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

- Bilirubin normal (unless due to Gilbert's disease or similar syndrome)*

- Alkaline phosphatase (AP) < 2.5 times upper limit of normal (ULN)*

- AST < 1.5 times ULN*

- PT INR > 1.5* allowed provided the following criteria are met:

- Patient is on full-dose anticoagulants

- INR in range (usually 2-3) on a stable dose of warfarin or low molecular weight

- No active bleeding or pathological condition associated with a high risk of
bleeding unrelated to primary colon tumor

- No systemic hepatic disease*

- Creatinine ≤ 1.5 times ULN*

- Urine protein:creatinine ratio < 1.0*

- Urine protein < 1 gm on 24-hour urine collection*

- No systemic renal disease*

- History of hypertension allowed provided blood pressure < 150/90 mm Hg while on a
stable regimen of anti-hypertensive therapy*

- No New York Heart Association class III or IV cardiac disease*

- No symptomatic arrhythmia*

- No history of transient ischemic attack*

- No history of cerebrovascular accident*

- No symptomatic peripheral vascular disease*

- No arterial thromboembolic events within the past 12 months*

- No unstable angina within the past 12 months*

- No myocardial infarction within the past 12 months*

- No other systemic cardiovascular disease*

- Not pregnant or nursing*

- Negative pregnancy test*

- Fertile patients must use effective contraception during and for 3 months after
completion of study treatment*

- No active gastroduodenal ulcer by endoscopy*

- No complete obstruction or perforation of the bowel

- No history of inflammatory bowel disease

- No prior or concurrent malignancy except for nonmelanoma skin cancer, carcinoma in
situ of the cervix, breast cancer in situ, treated non-pelvic cancer from which the
patient has been disease-free for > 5 years, or history of breast cancer (without
evidence of disease) and remain on hormonal therapy for > 5 years

- No other nonmalignant systemic disease that would preclude study compliance*

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

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

- No peripheral neuropathy ≥ grade 2*

- No significant traumatic injury within the past 4 weeks*

- No known allergy to platinum compounds

- No prior radiotherapy for this cancer

- No prior systemic therapy for this cancer

- More than 28 days since prior major surgery or open biopsy*

- More than 7 days since prior core biopsy or other minor procedure except placement of
a vascular access device*

Gender: Both
Steward Physician(s)
  • Al Benson
  • Peter J. O'Dwyer, MD, BCh
Trial Interventions
  • Bevacizumab
  • Fluorouracil
  • Leucovorin Calcium
  • Oxaliplatin
  • Laboratory Biomarker Analysis
Physician Researcher

Investigator Name:

  • Al Benson
  • Peter J. O'Dwyer, MD, BCh

Other Information

Sponsor: National Cancer Institute (NCI)
Phase: Phase 3
Trial ID: NCT00217737
Volunteers:  Not Accepting Healthy Volunteers

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