Irinotecan Compared With Combination Chemotherapy in Treating Patients With Advanced Colorectal Cancer

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Randomized phase III trial to compare the effectiveness of irinotecan with that of combination chemotherapy in treating patients who have advanced colorectal cancer that has not responded to previous treatment. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which chemotherapy regimen is more effective for colorectal cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Collaborators: Eastern Cooperative Oncology Group; Southwest Oncology Group
• Treatments: Calcium; Calcium, Dietary; Camptothecin; Fluorouracil; Irinotecan; Leucovorin; Levoleucovorin; Oxaliplatin

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