Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Related Publications
Trial Contact Information
Registry Information
Combination Chemotherapy in Treating Patients With Stage III Colon Cancer
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| Phase III | Treatment | Completed | 18 and over | NCI | CLB-89803 CAN-NCIC-CO15, E-89803, NCCTG-C89803, SWOG-C89803, NCT00003835, C89803, CO15 |
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
Ng K, Ogino S, Meyerhardt JA, et al.: Relationship between statin use and colon cancer recurrence and survival: results from CALGB 89803. J Natl Cancer Inst 103 (20): 1540-51, 2011.[PUBMED Abstract]
Ogino S, Shima K, Meyerhardt J, et al.: Predictive and Prognostic Roles of BRAF Mutation in Stage III Colon Cancer: Results from Intergroup Trial CALGB 89803. Clin Cancer Res : , 2011.[PUBMED Abstract]
McCleary NJ, Niedzwiecki D, Hollis D, et al.: Impact of smoking on patients with stage III colon cancer: results from Cancer and Leukemia Group B 89803. Cancer 116 (4): 957-66, 2010.[PUBMED Abstract]
Ng K, Meyerhardt JA, Chan JA, et al.: Multivitamin use is not associated with cancer recurrence or survival in patients with stage III colon cancer: findings from CALGB 89803. J Clin Oncol 28 (28): 4354-63, 2010.[PUBMED Abstract]
Bertagnolli MM, Niedzwiecki D, Compton CC, et al.: Microsatellite instability predicts improved response to adjuvant therapy with irinotecan, fluorouracil, and leucovorin in stage III colon cancer: Cancer and Leukemia Group B Protocol 89803. J Clin Oncol 27 (11): 1814-21, 2009.[PUBMED Abstract]
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]
Fuchs C, Ogino S, Meyerhardt JA, et al.: KRAS mutation, cancer recurrence, and patient survival in stage III colon cancer: findings from CALGB 89803. [Abstract] J Clin Oncol 27 (Suppl 15): A-4037, 2009.
Ogino S, Meyerhardt JA, Irahara N, et al.: KRAS mutation in stage III colon cancer and clinical outcome following intergroup trial CALGB 89803. Clin Cancer Res 15 (23): 7322-9, 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.
Related PublicationsBertagnolli MM, Redston M, Compton CC, et al.: Microsatellite instability and loss of heterozygosity at chromosomal location 18q: prospective evaluation of biomarkers for stages II and III colon cancer--a study of CALGB 9581 and 89803. J Clin Oncol 29 (23): 3153-62, 2011.[PUBMED Abstract]
Yothers G, Sargent DJ, Wolmark N, et al.: Outcomes among black patients with stage II and III colon cancer receiving chemotherapy: an analysis of ACCENT adjuvant trials. J Natl Cancer Inst 103 (20): 1498-506, 2011.[PUBMED Abstract]
Trial Lead Organizations
Cancer and Leukemia Group B
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| Leonard Saltz, MD, Protocol chair | |
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North Central Cancer Treatment Group
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| Richard Goldberg, MD, Protocol chair (Contact information may not be current) | |
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NCIC-Clinical Trials Group
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| David Klaassen, MD, Protocol chair (Contact information may not be current) | |
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Southwest Oncology Group
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| Alexander Hantel, MD, Protocol chair | |
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Eastern Cooperative Oncology Group
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| James Thomas, MD, PhD, Protocol chair | |
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| Registry Information | ||
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| Official Title | Phase III Intergroup Trial of Irinotecan (CPT-11) (NSC# 616348) Plus Luorouracil/Leucovorin (5-FU/LV) Versus Fluorouracil/Leucovorin Alone After Curative Resection for Patients with Stage III Colon Cancer | |
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| Trial Start Date | 1999-04-15 | |
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| Registered in ClinicalTrials.gov | NCT00003835 | |
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| Date Submitted to PDQ | 1999-03-26 | |
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| Information Last Verified | 2011-12-16 | |
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| NCI Grant/Contract Number | U10-CA31946 | |
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.
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