Status:
COMPLETED
Irinotecan, Fluorouracil, Leucovorin, and Oxaliplatin as First-Line Therapy in Treating Patients With Metastatic Colorectal Cancer
Lead Sponsor:
Alliance for Clinical Trials in Oncology
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as irinotecan, fluorouracil, leucovorin, and oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining mo...
Detailed Description
OBJECTIVES: Primary * Determine the tumor response rate in patients with metastatic colorectal cancer treated with irinotecan, fluorouracil, leucovorin calcium, and oxaliplatin as first-line treatme...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00080951
Start Date
March 1 2004
End Date
February 1 2008
Last Update
December 7 2016
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