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Amifostine Plus Irinotecan in Treating Patients With Metastatic Colorectal Cancer
This study is ongoing, but not recruiting participants.
First Received: November 1, 1999   Last Updated: July 23, 2008   History of Changes
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 30
Study Start Date: October 1997
Detailed Description:

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
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003225

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
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
Study Chair: Diane Prager, MD Jonsson Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

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

Keywords provided by National Cancer Institute (NCI):
stage IV colon cancer
stage IV rectal cancer
recurrent colon cancer
recurrent rectal cancer

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on February 08, 2010