Amifostine Plus Irinotecan in Treating Patients With Metastatic Colorectal Cancer
This study has been completed.
Sponsor:
Jonsson Comprehensive Cancer Center
Collaborators:
ALZA
Information provided by:
Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00003225
First received: November 1, 1999
Last updated: July 27, 2012
Last verified: July 2012
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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 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: 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 Jonsson Comprehensive Cancer Center:
Primary Outcome Measures:
- To assess the toxicity profile of Irinotecan and Ethyol when administered together on this schedule. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- To assess the total dose of Irinotecan received per 6 week cycle [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- To determine incidence of Irinotecan-induced leukopenia and neutropenia [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
- To determine the incidence of Irinotecan-induced diarrhea [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
- To determine the response rate for patients with metastatic colorectal carcinoma receiving Irinotecan and Ethyol on this dosing schedule (as measured by time response, duration of response time to progression, time of treatment failure survival). [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- To determine the clinical benefit of intravenous Irinotecan and Ethyol in patients with colorectal cancer, as measured by performance status, analgesic consumption, quality of life and survival. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 23 |
| Study Start Date: | July 1997 |
| Study Completion Date: | June 2001 |
| Primary Completion Date: | March 2000 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Ethyol plus Irinotecan
Ethyol 740 mg/m2 will be administered intravenously over 10 minutes. 10 minutes after completion of the Ethyol infusion, Irinotecan 250 mg/m2 will be given over 90 minutes IV.
|
Drug: amifostine trihydrate
Ethyol 740 mg/m2 will be administered intravenously over 10 minutes. Administered every two weeks for 3 cycles.
Other Name: Ethyol
Drug: irinotecan hydrochloride
10 minutes after completion of the Ethyol infusion, Irinotecan 250 mg/m2 will be given over 90 minutes IV. Administered every 14 days for 3 cycles |
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
Inclusion Criteria:
- 18 years of age or older
- ECOG 0-2
- Life expectancy of at least 12 weeks
- Pathologically confirmed diagnosis of metastatic colorectal cancer
- Measureable disease
- Have not received therapy for cancer within 4 weeks of enrollment on study
- Prior radiation therapy to the pelvis for treatment of colorectal cancer is allowed. Radiation therapy delivered elsewhere is allowed as long as the patient has been off treatment for at least six weeks and measurable lesions are present outside the radiation field
- Pretreatment granulocyte count of > 1500/mm3, hemoglobin > 9.0 g/dL (without transfusion), and platelet count of > 100,000/um
- Serum creatinine < 2.0 mg/dL
- Adequate hepatic function as documented by a serum bilirubin < 2.0 mg/dL regardless of whether patients have liver involvement secondary to tumor. AST must be < 3x the upper limit of normal unless the liver is involved with tumor, in which case the AST must be < 5x institutional upper limit of normal
Exclusion Criteria:
- Prior therapy with Irinotecan
- Patients with any active or uncontrolled infection
- Patients with psychiatric disorders that would interfere with consent or follow-up
- Patients with a history of myocardial infarction within the previous six months, congestive heart failure, or cerebrovascular disease
- History of prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for at least five years
- Presence of clinically apparent central nervous system metastases or carcinomatous meningitis
- Patients with uncontrolled diabetes mellitus
- Any other sever concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study
- Patients unable to stop taking antihypertensive medication 24 hour prior to administration of Ethyol (off x 1 day)
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
ALZA
Investigators
| Study Chair: | Diane Prager, MD | Jonsson Comprehensive Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Diane Prager, MD / Principal Investigator, UCLA |
| ClinicalTrials.gov Identifier: | NCT00003225 History of Changes |
| Other Study ID Numbers: | CDR0000066087, P30CA016042, UCLA-HSPC-970304601B, ALZA-UCLA-HSPC-970304601B, NCI-G98-1390 |
| Study First Received: | November 1, 1999 |
| Last Updated: | July 27, 2012 |
| Health Authority: | United States: Federal Government United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by Jonsson Comprehensive Cancer Center:
|
stage IV colon cancer stage IV rectal cancer recurrent colon cancer recurrent rectal cancer |
Additional relevant MeSH terms:
|
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Amifostine Protective Agents |
Irinotecan Camptothecin Radiation-Protective Agents Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses Radiation-Sensitizing Agents Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 21, 2013