Irinotecan, Fluorouracil, Leucovorin, and Oxaliplatin as First-Line Therapy in Treating Patients With Metastatic Colorectal Cancer

• Status: Completed
• Trial end date: 2008-02-01
• Target enrollment: 0
• Participant gender: All

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 more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy as first-line therapy in treating patients who have metastatic colorectal cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alliance for Clinical Trials in Oncology
• Collaborator: National Cancer Institute (NCI)
• Treatments: Calcium; Camptothecin; Fluorouracil; Irinotecan; Leucovorin; Levoleucovorin; Oxaliplatin

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