Irinotecan in Treating Patients With Colorectal Cancer

• Status: Terminated
• Trial end date: 2001-02-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of irinotecan in treating patients who have colorectal cancer.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: California Cancer Consortium
• Collaborator: National Cancer Institute (NCI)
• Treatments: Camptothecin; Irinotecan

Criteria

DISEASE CHARACTERISTICS:

• Histologically proven advanced or disseminated colorectal cancer

• Progressive disease on fluorouracil based chemotherapy OR

• Recurrence of disease within 12 months of adjuvant therapy with fluorouracil

• No known CNS metastases or carcinomatous meningitis

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• SWOG 0-2

Life expectancy:

• At least 12 weeks

Hematopoietic:

• Granulocyte count greater than 1500/mm^3

• Platelet count greater than 100,000/mm^3

• Hemoglobin at least 9.0 g/dL

Hepatic:

• Bilirubin no greater than 2 times upper limit of normal (ULN)

• SGOT no greater than 3 times ULN (no greater than 5 times ULN if liver involved)

Renal:

• Creatinine no greater than 2.0 mg/dL

• Calcium no greater than 12.0 mg/dL

Cardiovascular:

• No myocardial infarction within past 6 months

• No congestive heart failure requiring therapy

Neurologic:

• No severe psychiatric disorders

• No history of seizures

Other:

• No active or uncontrolled infection

• HIV negative

• No prior malignancy within past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

• No uncontrolled diabetes mellitus (random blood sugar 200 mg/dL or greater)

• No other severe concurrent disease

• Not pregnant or nursing

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• See Disease Characteristics

• Prior oxaliplatin allowed

• No prior irinotecan or topotecan

Endocrine therapy:

• Not specified

Radiotherapy:

• Not specified

Surgery:

• Not specified

Other:

• No concurrent phenytoin, phenobarbital, or other antiepileptic prophylaxis