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Phase III Intergroup Trial of Irinotecan (CPT-11) (NSC# 616348) Plus Fluorouracil/Leucovorin (5-FU/LV) Versus Fluorouracil/Leucovorin Alone After Curative Resection for Patients With Stage III Colon Cancer (NCT00003835)

Southwest Oncology Group
Eastern Cooperative Oncology Group
NCIC Clinical Trials Group
North Central Cancer Treatment Group
Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which chemotherapy regimen is more effective for stage III colon cancer. Randomized phase III trial to compare the effectiveness of fluorouracil plus leucovorin with or without irinotecan in treating patients who have undergone surgery for stage III colon cancer.
  • Drug: leucovorin calcium
    Given IV
    • Drug: fluorouracil
      Given IV
      • Drug: irinotecan hydrochloride
        Given IV
        • Other: laboratory biomarker analysis
          Correlative studies
          Ages eligible for Study
          18 Years and older
          Genders eligible for Study
          All
          Accepts Healthy Volunteers
          No
          PRIMARY OBJECTIVES:

          I. Compare the overall and disease free survival of patients with stage III colon cancer treated with adjuvant fluorouracil and leucovorin calcium with or without irinotecan.

          II. Assess prognostic markers and correlate their expression with disease free and overall survival of these patients.

          III. Assess the influence of diet, body mass index, and physical activity on the risk of cancer recurrence and survival in these patients.

          IV. Assess the influence of diet, obesity, and physical activity on the risk of toxicity associated with adjuvant therapy in these patients.

          V. Determine whether pathological features (including tumor grade, tumor mitotic (proliferation) index, tumor border configuration, and host lymphoid response to tumor; and lymphatic vessel, venous vessel and perineural invasion) predict outcome in this patient population.

          OUTLINE: This is a randomized, multicenter study. Patients are stratified according to lymph node involvement (1-3 vs 4 or more), histology (poorly differentiated or undifferentiated vs well or moderately differentiated), and preoperative serum CEA (less than 5.0 ng/mL vs at least 5.0 ng/mL vs unknown). Study therapy must begin within 21-56 days after surgery. Patients are randomized to one of two treatment arms:

          ARM I: Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV beginning 1 hour into leucovorin calcium infusion weekly for 6 weeks. Treatment is repeated every 8 weeks for 4 courses.

          ARM II: Patients receive irinotecan IV over 90 minutes, followed by leucovorin calcium IV, then followed by fluorouracil IV weekly for 4 weeks. Treatment is repeated every 6 weeks for 5 courses.

          Patients complete a food questionnaire at the beginning of the third course and then at 6 months after study therapy.

          Patients are followed every 3 months for 2 years, every 4 months for 2 years, then annually thereafter.

          PROJECTED ACCRUAL: A total of 1260 patients will be accrued for this study within 3 years.

          1 locations

          United States (1)
          • Cancer and Leukemia Group B
            Not specified
            Chicago, Illinois, United States, 60606
          Status:
          completed
          Type:
          Interventional
          Phase:
          Start:
          30 April, 1999
          Updated:
          06 October, 2013
          Participants:
          1260
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