|
||||||||||||||||||||||
|
|
Phase III Randomized Study of Fluorouracil and Leucovorin Calcium With or Without Irinotecan Following Curative Resection in Patients With Stage III Colon Cancer
Alternate Title Combination Chemotherapy in Treating Patients With Stage III Colon Cancer
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. Entry Criteria Disease Characteristics: Histologically proven stage III (Tx, N1-2, M0) adenocarcinoma of the colon Gross inferior (caudal) margin of primary tumor must be above the peritoneal reflection Completely resected with negative radial resecting margins No distant metastatic disease Prior/Concurrent Therapy: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for colon cancer No other concurrent chemotherapy Endocrine therapy: No concurrent hormone therapy except: Steroids for adrenal failure Hormones for nondisease related conditions (e.g., diabetes) Intermittent dexamethasone as an antiemetic Radiotherapy: No prior radiotherapy for colon cancer Surgery: See Disease Characteristics Patient Characteristics: Age: 18 and over Performance status: Zubrod 0-2 Life expectancy: Not specified Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than upper limit of normal (ULN) Renal: Creatinine no greater than 1.5 times ULN Other: No other prior or concurrent malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix Not pregnant or nursing Fertile patients must use effective contraception Expected Enrollment A total of 1260 patients will be accrued for this study within 3 years. 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.Published Results Bertagnolli MM, Warren RS, Niedzwiecki D, et al.: p27Kip1 in Stage III Colon Cancer: Implications for Outcome following Adjuvant Chemotherapy in Cancer and Leukemia Group B Protocol 89803. Clin Cancer Res 15 (6): 2116-22, 2009.[PUBMED Abstract] Bertagnolli MM, Niedzwiecki D, Compton CC, et al.: Microsatellite Instability Predicts Improves Response to Adjuvant Therapy With Irinotecan, Fluorouracil, and Leucovorin in Stage III Colon Cancer: Cancer and Leukemia Group B Protocol 89803. J Clin Oncol : , 2009.[PUBMED Abstract] Chan JA, Meyerhardt JA, Niedzwiecki D, et al.: Association of family history with cancer recurrence and survival among patients with stage III colon cancer. JAMA 299 (21): 2515-23, 2008.[PUBMED Abstract] Jackson NA, Fuchs CS, Niedzwiecki D, et al.: The impact of smoking on cancer recurrence and survival in patients with stage III colon cancer: findings from intergroup trial CALGB 89803. [Abstract] J Clin Oncol 26 (Suppl 15): A-4039, 2008. Meyerhardt JA, Niedzwiecki D, Hollis D, et al.: Impact of body mass index and weight change after treatment on cancer recurrence and survival in patients with stage III colon cancer: findings from Cancer and Leukemia Group B 89803. J Clin Oncol 26 (25): 4109-15, 2008.[PUBMED Abstract] Meyerhardt JA, Niedzwiecki D, Hollis D, et al.: The impact of dietary patterns on cancer recurrence and survival in patients with stage III colon cancer: findings from CALGB 89803. [Abstract] J Clin Oncol 25 (Suppl 18): A-4019, 2007. Meyerhardt JA, Niedzwiecki D, Hollis D, et al.: Association of dietary patterns with cancer recurrence and survival in patients with stage III colon cancer. JAMA 298 (7): 754-64, 2007.[PUBMED Abstract] Saltz LB, Niedzwiecki D, Hollis D, et al.: Irinotecan fluorouracil plus leucovorin is not superior to fluorouracil plus leucovorin alone as adjuvant treatment for stage III colon cancer: results of CALGB 89803. J Clin Oncol 25 (23): 3456-61, 2007.[PUBMED Abstract] Meyerhardt JA, Heseltine D, Niedzwiecki D, et al.: Impact of physical activity on cancer recurrence and survival in patients with stage III colon cancer: findings from CALGB 89803. J Clin Oncol 24 (22): 3535-41, 2006.[PUBMED Abstract] Fuchs C, Meyerhardt JA, Heseltine DL, et al.: Influence of regular aspirin use on survival for patients with stage III colon cancer: findings from Intergroup trial CALGB 89803. [Abstract] J Clin Oncol 23 (Suppl 16): A-3530, 253s, 2005. Meyerhardt JA, Heseltine D, Niedzwiecki D, et al.: The impact of physical activity on patients with stage III colon cancer: findings from Intergroup trial CALGB 89803. [Abstract] J Clin Oncol 23 (Suppl 16): A-3534, 254s, 2005. Saltz LB, Niedzwiecki D, Hollis D, et al.: Irinotecan plus fluorouracil/leucovorin (IFL) versus fluorouracil/leucovorin alone (FL) in stage III colon cancer (intergroup trial CALGB C89803). [Abstract] J Clin Oncol 22 (Suppl 14): A-3500, 245s, 2004. Trial Lead Organizations Cancer and Leukemia Group B
North Central Cancer Treatment Group
NCIC-Clinical Trials Group
Southwest Oncology Group
Eastern Cooperative Oncology Group
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. |
NCI Home |
Images Version |
Contact Us |
Policies |
Accessibility |
Viewing Files |
FOIA |
Site Help |
Site Map
|
A Service of the National Cancer Institute |