Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II, Phase I	Supportive care, Treatment	Closed	18 and over	NCI, Other	CDR0000066087 UCLA-HSPC-970304601B, ALZA-UCLA-HSPC-970304601B, NCI-G98-1390, NCT00003225

Trial Description

Summary

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

PURPOSE: Phase I/II trial to study the effectiveness of amifostine plus irinotecan in treating patients with metastatic colorectal cancer.

Further Study Information

OBJECTIVES: I. Assess the toxicity profile of irinotecan and amifostine when administered together in patients with metastatic colorectal cancer. II. Assess the total dose of irinotecan received per 6 week course in these patients. III. Determine the incidence of irinotecan-induced leukopenia, neutropenia, and diarrhea in these patients. V. Determine the response rate for this patient population.

OUTLINE: This is an open label study. Amifostine is administered by 10 minute IV infusions. Irinotecan is administered by IV infusions 15 minutes after completion of amifostine. Treatment is repeated every 2 weeks for 6 weeks. This 6 week course is repeated in the absence of disease progression. Treatment may be delayed up to 2 weeks after a course to allow for recovery from toxic effects. Patients are followed at the end of study and at 30 days after study.

PROJECTED ACCRUAL: There will be 25-30 patients accrued into this study.

Eligibility Criteria

DISEASE CHARACTERISTICS: Histologically confirmed metastatic colorectal cancer Measurable disease No CNS metastases or carcinomatous meningitis

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9.0 g/dL Hepatic: Bilirubin no greater than 2.0 mg/dL (regardless of liver involvement secondary to tumor) AST no greater than 3 times upper limit of normal (ULN) (no greater than 5 times ULN if liver involvement) Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No history of myocardial infarction in the last 6 months No congestive heart failure No cerebrovascular disease requiring therapy Other: No prior malignancy within 5 years except adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer No uncontrolled diabetes mellitus (defined as random blood sugar at least 200 mg/dL) No active or uncontrolled infection No other severe concurrent disease No psychiatric disorders that would interfere with study

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since any prior biologic therapy for cancer Chemotherapy: At least 4 weeks since any prior chemotherapy for cancer No prior irinotecan Endocrine therapy: At least 4 weeks since any prior endocrine therapy for cancer Radiotherapy: Prior radiotherapy to pelvis for colorectal cancer is allowed At least 6 weeks since radiotherapy to other areas if measurable lesions are present outside of the radiation field Surgery: Not specified Other: At least 24 hours since antihypertensive medication

Trial Contact Information

Trial Lead Organizations/Sponsors

Jonsson Comprehensive Cancer Center at UCLA

Diane Prager, MD

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00003225
Information obtained from ClinicalTrials.gov on October 19, 2009

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