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A Randomized Phase III Trial of Oxaliplatin (OXAL) Plus 5-Fluorouracil (5-FU)/Leucovorin (CF) With or Without Cetuximab (C225) After Curative Resection for Patients With Stage III Colon Cancer

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Trial Conditions
  • Colorectal Cancer
  • Adenocarcinoma of the Colon
  • Stage III Colon Cancer
What is the purpose of this trial?

This randomized phase III trial is comparing three different combination chemotherapy regimens to see how well they work when given with or without cetuximab in treating patients who have undergone surgery for stage III colon cancer. (As of 6/1/2005, patients will no longer receive irinotecan on this study.) Drugs used in chemotherapy, such as irinotecan hydrochloride, fluorouracil, leucovorin calcium, and oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining more than one chemotherapy drug with monoclonal antibody therapy and giving them after surgery may kill any remaining tumor cells. It is not yet known which combination chemotherapy regimen is more effective after surgery in treating colon cancer. (As of 6/1/2005, patients will no longer receive irinotecan on this study.

Date & Status

Active, not recruiting

Who can Participate?

Eligibility

Ages:
18  - 69 

Gender:
Both

Eligibility

Inclusion Criteria:

- Histologically confirmed adenocarcinoma of the colon

- Stage III disease

- No resected stage IV disease

- No rectal cancer

- Gross inferior (caudad) margin of the primary tumor must be ≥ 12 cm from the
anal verge by rigid proctoscopy

- Stage III tumor must have been completely resected within the past 56 days

- Must have documented en bloc resection in patients with tumor adherence to
adjacent structures

- Tumor-related obstructions and colonic perforation are allowed

- Tumor samples must be available

- At least 1 pathologically confirmed positive lymph node

- No evidence of residual involved lymph node disease

- Synchronous primary colon cancer allowed

- No distant metastatic disease

- Performance status - ECOG 0-2

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin ≥ 9 g/dL

- Bilirubin ≤ 1.5 times upper limit of normal (ULN)

- Creatinine ≤ 1.5 times ULN

- No uncontrolled high blood pressure

- No unstable angina

- No symptomatic congestive heart failure

- No myocardial infarction with the past 6 months

- No New York Heart Association class III or IV heart disease

- No symptomatic pulmonary fibrosis

- No symptomatic interstitial pneumonitis

- No prior allergic reaction (known sensitivity) to chimerized or murine monoclonal
antibody therapy

- No known allergy to platinum compounds

- No documented presence of human anti-mouse antibodies (HAMA)

- No active uncontrolled bacterial, viral, or systemic fungal infection

- HIV negative

- No clinically defined AIDS

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 2 months after study
participation

- No inadequately treated gastrointestinal bleeding

- No ≥ grade 2 pre-existing peripheral sensory or motor neuropathy

- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer, carcinoma in situ of the cervix, or lobular carcinoma in
situ in 1 breast

- No other concurrent medical condition that would preclude study participation

- No concurrent biologic therapy

- No concurrent oprelvekin

- No concurrent pegfilgrastim

- No prior chemotherapy for colon cancer

- No other concurrent chemotherapy

- No prior radiotherapy for colon cancer

- No concurrent targeted agents

- No prior agents directed against epidermal growth factor-receptor

- No concurrent ketoconazole or other potent inhibitors of CYP3A4 (e.g., itraconazole
or voriconazole)

- No other concurrent anticancer therapy

Gender: Both
Steward Physician(s)
  • Frank Sinicrope
  • Albert M. Bernath, MD
  • Frank Sinicrope, MD
  • Emily Chan, MD, PhD
Facilities
  • St. Elizabeth's Medical Center - Active, not recruiting
Trial Interventions
Biological
  • cetuximab
Drug
  • irinotecan hydrochloride
  • oxaliplatin
  • leucovorin calcium
  • fluorouracil
Physician Researcher

Investigator Name:

  • Frank Sinicrope
  • Albert M. Bernath, MD
  • Frank Sinicrope, MD
  • Emily Chan, MD, PhD

Other Information

Sponsor: National Cancer Institute (NCI)
Phase: Phase 3
Trial ID: NCT00079274
Volunteers:  Not Accepting Healthy Volunteers

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