Combination Chemotherapy in Treating Patients With Stage III Colon Cancer
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| ClinicalTrials.gov Identifier: NCT00003835 |
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Recruitment Status :
Completed
First Posted : April 27, 2004
Last Update Posted : October 8, 2013
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Adenocarcinoma of the Colon Stage III Colon Cancer | Drug: leucovorin calcium Drug: fluorouracil Drug: irinotecan hydrochloride Other: laboratory biomarker analysis | Phase 3 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 1260 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | 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 |
| Study Start Date : | May 1999 |
| Actual Primary Completion Date : | August 2007 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: 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.
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Drug: leucovorin calcium
Given IV Drug: fluorouracil Given IV Other: laboratory biomarker analysis Correlative studies |
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Experimental: 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
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Drug: leucovorin calcium
Given IV Drug: fluorouracil Given IV Drug: irinotecan hydrochloride Given IV Other: laboratory biomarker analysis Correlative studies |
- 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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003835
| United States, Illinois | |
| Cancer and Leukemia Group B | |
| Chicago, Illinois, United States, 60606 | |
| Principal Investigator: | Leonard Saltz | Cancer and Leukemia Group B |
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003835 |
| Other Study ID Numbers: |
NCI-2012-01844 NCI-2012-01844 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) SWOG-C89803 NCCTG-C89803 CDR0000066992 CAN-NCIC-CO15 E-89803 CALGB 89803 ( Other Identifier: Cancer and Leukemia Group B ) C89803 ( Other Identifier: CTEP ) U10CA031946 ( U.S. NIH Grant/Contract ) |
| First Posted: | April 27, 2004 Key Record Dates |
| Last Update Posted: | October 8, 2013 |
| Last Verified: | October 2013 |
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Colonic Neoplasms Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Leucovorin Fluorouracil Irinotecan Calcium |
Levoleucovorin Calcium-Regulating Hormones and Agents Physiological Effects of Drugs Antimetabolites Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Antineoplastic Agents Immunosuppressive Agents Immunologic Factors Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Antidotes Protective Agents Vitamin B Complex |