Phase II Trial Of Irinotecan + 5-Fluorouracil + Leucovorin + Oxaliplatin As First-Line Treatment For Metastatic Colorectal Cancer
fluorouracil
+ irinotecan hydrochloride
+ leucovorin calcium
Colonic Diseases+8
+ Digestive System Diseases
+ Digestive System Neoplasms
Treatment Study
Summary
Study start date: March 1, 2004
Actual date on which the first participant was enrolled.OBJECTIVES: Primary * Determine the tumor response rate in patients with metastatic colorectal cancer treated with irinotecan, fluorouracil, leucovorin calcium, and oxaliplatin as first-line treatment. Secondary * Determine the time to tumor progression, time to treatment failure, and overall survival of patients treated with this regimen. * Determine the toxicity of this regimen in these patients. * Determine the quality of life of patients treated with this regimen. * Determine whether UGT1A1 polymorphism is related to toxicity (especially leukopenia, diarrhea, or neutropenia) or response in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive irinotecan IV over 90 minutes and oxaliplatin IV over 2 hours on day 1 and leucovorin calcium IV and fluorouracil IV over 90 minutes on days 2-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, before each chemotherapy course, and at the end of treatment. Patients are followed every 3 months until 5 years after registration.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.14 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.From 18 to 120 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
DISEASE CHARACTERISTICS: * Diagnosis of colorectal adenocarcinoma * Metastatic disease * Not curable by surgery or amenable to radiotherapy with curative intent * Measurable disease * Patients with only lesions measuring ≥ 1 cm but \< 2 cm must use spiral CT scan for pre- and post-treatment tumor assessments * No known CNS metastases or carcinomatous meningitis PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 Life expectancy * At least 12 weeks Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 Hepatic * AST ≤ 5 times upper limit of normal (ULN) * Bilirubin ≤ 0.5 mg/dL above ULN Renal * Creatinine ≤ 1.5 times ULN OR * Creatinine clearance ≥ 60 mL/min Cardiovascular * No unstable angina * No symptomatic congestive heart failure * No serious uncontrolled cardiac arrhythmia Pulmonary * No prior clinical diagnosis of interstitial lung disease Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No active or uncontrolled infection * No other concurrent serious illness * No pre-existing paraesthesias/dysesthesias of ≥ grade 2 that would interfere with function * No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or adequately treated noninvasive carcinomas PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent sargramostim (GM-CSF) Chemotherapy * At least 6 months since prior adjuvant chemotherapy * No prior fluorouracil for advanced colorectal cancer * No prior adjuvant oxaliplatin * No prior adjuvant irinotecan Endocrine therapy * Not specified Radiotherapy * No prior radiotherapy to \> 25% of bone marrow Surgery * At least 4 weeks since prior major surgery
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives