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
Maladies du côlon+10
+ Maladies du système digestif
+ Néoplasmes du système digestif
Étude thérapeutique
Résumé
Date de début de l'étude : 1 novembre 1999
Date à laquelle le premier participant a commencé l'étude.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.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.560 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.À partir de 18 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
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
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.2 groupes d'intervention sont désignés dans cette étude
Cette étude ne comporte pas de groupe placebo.
Groupes de traitement
Groupe I
ExpérimentalGroupe II
ExpérimentalObjectifs de l'étude
Objectifs principaux
Objectifs secondaires
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site
North Central Cancer Treatment Group
Rochester, United StatesOuvrir North Central Cancer Treatment Group dans Google Maps