A Randomized Phase III Equivalence Trial of Irinotecan (CPT-11) Versus Oxaliplatin (OXAL)/5-Fluorouracil (5-FU)/Leucovorin (CF) in Patients With Advanced Colorectal Carcinoma Previously Treated With 5-FU
irinotecan hydrochloride
+ quality-of-life assessment
+ oxaliplatin
Colonic Diseases+10
+ Digestive System Diseases
+ Digestive System Neoplasms
Treatment Study
Summary
Study start date: November 1, 1999
Actual date on which the first participant was enrolled.PRIMARY OBJECTIVES: I. Determine whether in advanced colorectal carcinoma patients who have been previously treated with 5-FU, the overall survival of patients treated with OXAL + 5-FU + CF followed by CPT-11 is equivalent to the survival of patients treated with CPT-11 followed by OXAL + 5-FU + CF. SECONDARY OBJECTIVES: I. Evaluation of time to tumor progression, time to treatment failure, toxicity of treatment, and overall response rate in patients treated with these two regimens. II. To compare quality-of-life measurements patients treated with these two regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to performance status (ECOG 0-1 vs 2), primary indicator lesion (hepatic vs pulmonary vs other), age (less than 65 vs at least 65 years), alkaline phosphatase (less than 2 vs at least 2 times ULN), fluorouracil failure (adjuvant vs metastatic), and membership (intergroup vs expanded participation project). Patients are randomized to one of two treatment arms. ARM I: Patients receive irinotecan IV over 90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive oxaliplatin IV over 2 hours on day 1, leucovorin calcium IV over 2 hours on days 1 and 2, and fluorouracil IV bolus followed by IV infusion over 22 hours on days 1 and 2. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity. Patients who experience progression or toxicity on the initial regimen may crossover to the other regimen. At least 3 weeks must elapse between regimens. Quality of life is assessed at baseline, prior to each chemotherapy course, at crossover, and at the end of the study. Patients are followed every 6 months for 3 years or until death.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.560 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: Histologically or cytologically confirmed locally advanced, locally recurrent,or metastatic colorectal adenocarcinoma not curable by surgery or radiotherapy Progressive disease following: One prior fluorouracil based chemotherapy regimen for metastatic disease Failure during or within 6 months after fluorouracil based adjuvant therapy Measurable or evaluable disease No CNS metastases or carcinomatous meningitis Performance status - ECOG 0-2 At least 12 weeks Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 9 g/dL (transfusion allowed) Bilirubin no greater than 1.5 mg/dL AST no greater than 5 times upper limit of normal (ULN) Alkaline phosphatase no greater than 5 times ULN Creatinine no greater than 1.5 times ULN No uncontrolled high blood pressure No unstable angina No symptomatic congestive heart failure No myocardial infarction with the past 6 months No serious uncontrolled cardiac arrhythmias No New York Heart Association class III or IV heart disease No pleural effusion or ascites that cause respiratory compromise (e.g., dyspnea grade 2 or greater) No interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung Not pregnant or nursing Fertile patients must use effective contraception Fluent in English No active or uncontrolled infection No other prior malignancy within the past 5 years, except: Adequately treated basal or squamous cell skin cancer Adequately treated noninvasive carcinomas No sensory neuropathy grade 2 or greater No uncontrolled colonic or small bowel disorders (greater than 3 loose stools daily) No concurrent sargramostim (GM-CSF) At least 4 weeks since prior chemotherapy and recovered No more than 1 prior chemotherapy regimen for advanced colorectal cancer No prior irinotecan or other camptothecin derivative (e.g., topotecan) No prior oxaliplatin No other concurrent investigational chemotherapy agents At least 4 weeks since prior major radiotherapy No prior radiotherapy to greater than 25% of bone marrow At least 4 weeks since prior major surgery and recovered At least 2 weeks since prior minor surgery and recovered
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
North Central Cancer Treatment Group
Rochester, United StatesOpen North Central Cancer Treatment Group in Google Maps