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
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 1,260
- Locations
- 1
- Primary Endpoint
- Time to recurrence
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients must have histologically documented adenocarcinoma of the colon; the gross inferior (caudad) margin of the primary tumor must lie above the peritoneal reflection; tumor must have been completely resected, including negative radial resecting margins
- •There must be no history of distant metastatic disease at the time of registration
- •Pathological evaluation must show Modified Astler-Coller stage C (TxN1-2M0) disease
- •No previous or concurrent malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for five years
- •Zubrod performance status of 0-2
- •Non-pregnant and not nursing, as chemotherapy is thought to present substantial risk to the fetus/infant; men and women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method while in this study
- •Granulocytes >= 1,500/ul
- •Platelet count >= 100,000/ul
- •Creatinine =< 1.5 x upper limits of normal
- •Bilirubin =< upper limit of normal
Exclusion Criteria
- Not provided
Arms & Interventions
Arm I (leucovorin calcium and fluorouracil)
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.
Intervention: leucovorin calcium (Drug)
Arm I (leucovorin calcium and fluorouracil)
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.
Intervention: fluorouracil (Drug)
Arm I (leucovorin calcium and fluorouracil)
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.
Intervention: laboratory biomarker analysis (Other)
Arm II (leucovorin calcium, fluorouracil, irinotrcan)
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
Intervention: leucovorin calcium (Drug)
Arm II (leucovorin calcium, fluorouracil, irinotrcan)
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
Intervention: fluorouracil (Drug)
Arm II (leucovorin calcium, fluorouracil, irinotrcan)
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
Intervention: irinotecan hydrochloride (Drug)
Arm II (leucovorin calcium, fluorouracil, irinotrcan)
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
Intervention: laboratory biomarker analysis (Other)
Outcomes
Primary Outcomes
Time to recurrence
Time Frame: From time of resection until documented disease progression, assessed up to 6 years
The Cox proportional hazards model will be used to determine the association between each marker and time to recurrence and survival controlling for other baseline factors such as age, gender, treatment, primary tumor site, degree of differentiation.
Survival
Time Frame: Up to 6 years
The Cox proportional hazards model will be used to determine the association between each marker and time to recurrence and survival controlling for other baseline factors such as age, gender, treatment, primary tumor site, degree of differentiation.
Secondary Outcomes
No secondary outcomes reported