SWOG clinical trial number
N9741
A Randomized Phase III Trial of Combinations of Oxaliplatin (OXAL), 5-Fluorouracil (5-FU) and Irinotecan (CPT-11) as Initial Treatment of Patients With Advanced Adenocarcinoma of the Colon and Rectum
Abbreviated Title
COLORECTAL
Treatment
Irinotecan
Leucovorin + 5-FU
Oxaliplatin
Known locally adv, locally recurrent or met colorectal adenocarcinoma not curable by surg or amenable to RT w/curative intent. Histo or cyto doc locally adv; site of primary lesion conf endoscopically, radiologically or surgically to be or have been in lg bowel. Meas or eval disease. Life expect > = 12 wks. ECOG PS 0-2. Able to complete ?'s. > = 4 wks from major surgery; > = 2 wks from minor surgery; > = 4 wks from major RT. Following labs obtained < = 14 days prior rand: AGC > =1500 mm3; PLT > = 100,000 mm3; HGB > = 9.0 gm/dL; creatinine < = 1.5 x UNL; bili < = 1.5 mg/dL; AST < = 5 x UNL; alk phos < = 5 x UNL. Pts of childbearing potential must agree to use eff meth of contraception. Pts may have rec'd adj therapy for resected Stage II, III or IV disease with any regimen containing 5-FU or w/immunotherapy providing that at least 12 months have elapsed from time adj therapy concluded and that recurrent disease was doc. Pt must not have had prior chemo for adv colorectal ca, prior RT to > 15% of bone marrow; concurrent use of other investigational agents. Pt must not have active or uncontrolled inf; symptomatic sensory peripheral neuropathy; uncontrolled high blood pressure; unstable angina; symptomatic congestive heart failure; myocardial infarction < = 6 months prior to rand; serious uncontrolled cardiac arrhythmia nor NY Heart Assoc classification III or IV. Pt must not be pregnant or nursing. Pt must have no other concurrent cancers or previous cancers within the past 3 years; known CNS mets or carcinomatous meningitis; interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung; pleural effusion or ascites which cause respiratory compromise; predisposing colonic or small bowel disorders in which symptoms are uncontrolled; medical or psychiatric conditions which in the opinion of the inv make participation in an inv trial a poor risk.
CANCER CONTROL CREDIT: 0.3
TREATMENT CREDIT: 1.0
2008
Five-year data and prognostic factor analysis of oxaliplatin and irinotecan combinations for advanced colorectal cancer: N9741 [PMID19001325; PMC2645101]
HK Sanoff;DJ Sargent;ME Campbell;RF Morton;CS Fuchs;RK Ramanathan;SK Williamson;BP Findlay;HC Pitot;R Goldberg Journal of Clinical Oncology 26(35):5721-5727
2004
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
C Fuchs;M Pollak;DJ Sargent;JA Meyerhardt;RK Ramanathan;SK Williamson;B Findlay;E Green;KM Goldberg Proc of the American Society of Clinical Oncology 23:250 (#3521)
N9741: FOLFOX (oxaliplatin (oxal)/ 5-fluorouracil (5-FU)/ leucovorin (LV) or reduced dose R-IFL (CPT-11 + 5-FU/LV) in advanced colorectal cancer (CRC): Final efficacy data from an intergroup study
RM Goldberg;DJ Sargent;RF Morton;C Fuchs;RK Ramanathan;SK Williamson;BP Findlay;HR Pitot;SR Alberts Proc of the American Society of Clinical Oncology 23:275 (#3621)
Preliminary evidence of relationship between genetic markers and oncology patient quality of life (QOL).
JA Sloan;H McLeod;D Sargent;X Zhao;C. Goldberg Proc of the American Society of Clinical Oncology 23:2 (#5)
N9741: Oxaliplatin (Oxal) + CPT-11 or 5-fluorouracil (5FU)/leucovorin (LV) in advanced colorectal cancer (CRC): final efficacy data from an intergroup study
RM Goldberg;RF Morton;DJ Sargent;CS Fuchs;RK Ramanathan;SK Williamson;BP Findley ASCO Gastrointestinal Cancers Symposium #215
2002
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.
RM Goldberg;RF Morton;DJ Sargent;CS Fuchs;RK Ramanathan;SK Williamson;BP Findlay Proc of the American Society of Clinical Oncology 21:128a(#511)
