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Phase III Randomized Study of Combinations of Oxaliplatin, Fluorouracil, Leucovorin Calcium, and Irinotecan as Initial Therapy in Patients With Advanced Adenocarcinoma of the Colon and Rectum
Alternate Title Combination Chemotherapy in Treating Patients With Advanced Colorectal Cancer
Objectives
Entry Criteria Disease Characteristics:
Prior/Concurrent Therapy: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Patient Characteristics: Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
Expected Enrollment A total of 825 patients (275 per arm) have been accrued for this study thus far. Additional patients are being accrued on arm II. (Arms I and III closed to accrual as of March 15, 2002.) Outline This is a randomized, multicenter study. Patients are stratified according to ECOG performance status (0-1 vs 2), prior adjuvant chemotherapy (yes vs no), prior immunotherapy (yes vs no), and age (under 65 vs 65 and over). Patients are randomized to one of three treatment arms. Only arm II remains open to accrual.
Treatment continues in the absence of disease progression or unacceptable toxicity. Quality of life is assessed before treatment, during treatment (arm specific), and after completion of treatment. Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter. Published ResultsFuchs CS, Goldberg RM, Sargent DJ, et al.: Plasma insulin-like growth factors, insulin-like binding protein-3, and outcome in metastatic colorectal cancer: results from intergroup trial N9741. Clin Cancer Res 14 (24): 8263-9, 2008.[PUBMED Abstract] Sanoff HK, Sargent DJ, Campbell ME, et al.: Five-year data and prognostic factor analysis of oxaliplatin and irinotecan combinations for advanced colorectal cancer: N9741. J Clin Oncol 26 (35): 5721-7, 2008.[PUBMED Abstract] Sargent DJ, Campbell M, Grothey A, et al.: Overall and 12 week tumor response versus actual tumor measurements as predictors of overall survival (OS) in advanced colorectal cancer (ACRC): findings from NCCTG N9741. [Abstract] American Society of Clinical Oncology 2008 Gastrointestinal Cancers Symposium, 25-27 January 2008, Orlando, FL. A-446, 2008. Dy GK, Krook JE, Green EM, et al.: Impact of complete response to chemotherapy on overall survival in advanced colorectal cancer: results from Intergroup N9741. J Clin Oncol 25 (23): 3469-74, 2007.[PUBMED Abstract] Grothey A, Sargent DJ, Campbell ME, et al.: Waterfall plots provide detailed information on magnitude of response to conventional chemotherapy in colorectal cancer: lessons learned from N9741. [Abstract] American Society of Clinical Oncology 2007 Gastrointestinal Cancers Symposium, 19 -21 January 2007, Orlando, Florida A-337, 2007. Goldberg RM, McLeod HL, Sargent DJ, et al.: Genetic polymorphisms, toxicity, and response rate in African Americans (AA) with metastatic colorectal cancer (MCRC) compared to Caucasians (C) when treated with IFL, FOLFOX or IROX in Intergroup N9741. [Abstract] J Clin Oncol 24 (Suppl 18): A-3503, 2006. Goldberg RM, Sargent DJ, Morton RF, et al.: Randomized controlled trial of reduced-dose bolus fluorouracil plus leucovorin and irinotecan or infused fluorouracil plus leucovorin and oxaliplatin in patients with previously untreated metastatic colorectal cancer: a North American Intergroup Trial. J Clin Oncol 24 (21): 3347-53, 2006.[PUBMED Abstract] McLeod HL, Parodi L, Sargent DJ, et al.: UGT1A1*28, toxicity and outcome in advanced colorectal cancer: results from trial N9741. [Abstract] J Clin Oncol 24 (Suppl 18): A-3520, 2006. Delaunoit T, Alberts SR, Sargent DJ, et al.: Chemotherapy permits resection of metastatic colorectal cancer: experience from Intergroup N9741. Ann Oncol 16 (3): 425-9, 2005.[PUBMED Abstract] Dy GK, Krook J, Green E, et al.: Impact of complete response to chemotherapy on overall survival (OS) in advanced colorectal cancer (CRC): results from Intergroup N9741. [Abstract] American Society of Clinical Oncology 2005 Gastrointestinal Cancers Symposium, 27-29 January 2005, Miami, Florida. A-185, 2005. Delaunoit T, Goldberg RM, Sargent DJ, et al.: Mortality associated with daily bolus 5-fluorouracil/leucovorin administered in combination with either irinotecan or oxaliplatin: results from Intergroup Trial N9741. Cancer 101 (10): 2170-6, 2004.[PUBMED Abstract] Fuchs C, Pollak M, Sargent DJ, et al.: Insulin-like growth factor-I (IGF-1), IGF binding protein-3 (IGFBP-3), and outcome in metastatic colorectal cancer (CRC): results from intergroup trial N9741. [Abstract] J Clin Oncol 22 (Suppl 14): A-3521, 250s, 2004. Goldberg RM, Sargent DJ, Morton RF, et al.: A randomized controlled trial of fluorouracil plus leucovorin, irinotecan, and oxaliplatin combinations in patients with previously untreated metastatic colorectal cancer. J Clin Oncol 22 (1): 23-30, 2004.[PUBMED Abstract] Goldberg RM, Morton RF, Sargent DJ, et al.: N9741: oxaliplatin (Oxal) or CPT-11 + 5-fluorouracil (5FU)/leucovorin (LV) or oxal + CPT-11 in advanced colorectal cancer (CRC). Updated efficacy and quality of life (QOL) data from an intergroup study. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-1009, 252, 2003. Goldberg RM, Morton RF, Sargent D, et al.: N9741: oxaliplatin (oxal) or CPT-11 + 5-fluorouracil (5FU)/leucovorin (LV) or oxal + CPT-11 in advanced colorectal cancer (CRC). Initial toxicity and response data from a GI Intergroup study. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-511, 2002. Morton RF, Goldberg RM, Sargent DJ, et al.: Oxaliplatin (OXAL) or CPT-11 Combined with 5FU/Leucovorin (LV) in Advanced Colorectal Cancer (CRC): an NCCTG/CALGB Study. [Abstract] Proceedings of the American Society of Clinical Oncology 20: A-495, 2001. Related PublicationsCampbell ME, Mandrekar SJ, Hillman SL, et al.: What is the added value of actual tumor measurements (TM) in predicting overall survival (OS)? The North Central Cancer Treatment Group (NCCTG) findings. [Abstract] J Clin Oncol 26 (Suppl 15): A-6520, 2008. Grothey A, Hedrick EE, Mass RD, et al.: Response-independent survival benefit in metastatic colorectal cancer: a comparative analysis of N9741 and AVF2107. J Clin Oncol 26 (2): 183-9, 2008.[PUBMED Abstract] Grothey A, Hedrick EE, Mass RD, et al.: Response rate using conventional criteria is a poor surrogate for clinical benefit on progression-free (PFS) and overall survival (OS) in metastatic colorectal cancer (mCRC): a comparative analysis of N9741 and AVF2107. [Abstract] J Clin Oncol 24 (Suppl 18): A-3516, 2006. Goldberg R: Oxaliplatin in colorectal cancer: current studies. Oncology (Huntingt) 14 (12 Suppl 11): 42-7, 2000.[PUBMED Abstract] Trial Lead Organizations North Central Cancer Treatment Group
Cancer and Leukemia Group B
NCIC-Clinical Trials Group
Eastern Cooperative Oncology Group
Southwest 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. |
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