Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information
Combination Chemotherapy in Treating Patients With Metastatic Ovarian Cancer or Non-small Cell Lung Cancer
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| Phase II | Supportive care, Treatment | Closed | 18 and over | Pharmaceutical / Industry | UCSF-H57841348101A ALZA-UCSF-H57841348101A, NCI-V97-1334, NCT00003072 |
Objectives
I. Determine whether patients with metastatic ovarian and non-small cell lung cancer receiving carboplatin and paclitaxel have significantly fewer neuropathic events when treated with amifostine.
Entry Criteria
Disease Characteristics:
Histologically proven stage III/IV ovarian or non-small cell lung cancer
Prior/Concurrent Therapy:
Biologic therapy: Not specified Chemotherapy: No prior chemotherapy within 1 month of study Endocrine therapy: Not specified Radiotherapy: No prior radiation therapy within 1 month of study Surgery: Not specified
Patient Characteristics:
Age: 18 and over Performance Status: ECOG 0-2 Life Expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 3.0 mg/dL Renal: Creatinine no greater than 2 mg/dL Other: Not pregnant or nursing No history of platinum, paclitaxel or amifostine hypersensitivity Prior myelosuppressive events allowed No clinically significant ascites
Expected Enrollment
80A total of 80 patients will be accrued (40 with advanced ovarian cancer and 40 with advanced non-small cell lung cancer) within 2 years.
Outline
This is a randomized, parallel group, double blind, controlled study. Patients are randomized to either the amifostine or control group. All patients receive intravenous paclitaxel over 3 hours, followed by carboplatin once every 3 weeks for 6 cycles. Patients who are randomized to the amifostine group receive intravenous amifostine administered as a 15 minute infusion 30 minutes prior to paclitaxel therapy. Patients randomized to the control group receive an intravenous placebo solution. Patients are discontinued from the study if they have disease progression or unacceptable toxic effects after 2 cycles of treatment. Patients are followed monthly for 8 months post treatment.
Trial Lead Organizations
UCSF Helen Diller Family Comprehensive Cancer Center
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| Robert Ignoffo, PharmD, Protocol chair | |
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| Registry Information | ||
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| Official Title | Amifostine (Ethyol) as a Protectant in Metastatic Ovarian and Non-Small Cell Lung Cancer in Paclitaxel/Carboplatin-Treated Patients: A Comparative Trial | |
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| Trial Start Date | 1997-05-28 | |
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| Registered in ClinicalTrials.gov | NCT00003072 | |
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| Date Submitted to PDQ | 1997-09-03 | |
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| Information Last Verified | 2006-05-19 | |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.
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