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

Completed · Phase 3

Conditions studied: Mucinous Adenocarcinoma of the Colon, Mucinous Adenocarcinoma of the Rectum, Recurrent Colon Cancer, Recurrent Rectal Cancer, Signet Ring Adenocarcinoma of the Colon, Signet Ring Adenocarcinoma of the Rectum, Stage IIIA Colon Cancer, Stage IIIA Rectal Cancer, Stage IIIB Colon Cancer, Stage IIIB Rectal Cancer, Stage IIIC Colon Cancer, Stage IIIC Rectal Cancer, Stage IVA Colon Cancer, Stage IVA Rectal Cancer, Stage IVB Colon Cancer, Stage IVB Rectal Cancer

In brief

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.

Key facts

Study ID

NCT00005036

Run by

National Cancer Institute (NCI)

People needed

560

Starts

1999-11-01

Last updated by the study team

2013-05-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• North Central Cancer Treatment Group — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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