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| Sponsor: | Jonsson Comprehensive Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003225 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer |
Drug: amifostine trihydrate Drug: irinotecan hydrochloride |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Phase I/II Trial to Evaluate Ethyol as a Protective Agent for Irinotecan (CPT-11) Toxicities in Patients With Advanced Colorectal Cancer |
| Estimated Enrollment: | 30 |
| Study Start Date: | October 1997 |
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, California | |
| Jonsson Comprehensive Cancer Center, UCLA | |
| Los Angeles, California, United States, 90095-1781 | |
| Wilshire Oncology Medical Group, Inc. | |
| Rancho Cucamonga, California, United States, 91730 | |
| Study Chair: | Diane Prager, MD | Jonsson Comprehensive Cancer Center |
More Information
| Study ID Numbers: | CDR0000066087, UCLA-HSPC-970304601B, ALZA-UCLA-HSPC-970304601B, NCI-G98-1390 |
| Study First Received: | November 1, 1999 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00003225 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage IV colon cancer stage IV rectal cancer recurrent colon cancer recurrent rectal cancer |
|
Radiation-Protective Agents Digestive System Neoplasms Molecular Mechanisms of Pharmacological Action Amifostine Antineoplastic Agents Gastrointestinal Diseases Physiological Effects of Drugs Colonic Diseases Irinotecan Enzyme Inhibitors Intestinal Diseases Protective Agents |
Rectal Diseases Pharmacologic Actions Camptothecin Intestinal Neoplasms Neoplasms Neoplasms by Site Digestive System Diseases Therapeutic Uses Gastrointestinal Neoplasms Antineoplastic Agents, Phytogenic Colorectal Neoplasms |