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| Sponsor: | University of California, San Francisco |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003072 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving the drugs in different combinations may kill more tumor cells.
PURPOSE: Randomized phase II double-blinded trial to study the effectiveness of paclitaxel and carboplatin given with either amifostine or placebo in patients with metastatic stage III or stage IV ovarian cancer or metastatic stage III or stage IV non-small cell lung cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer Neurotoxicity Ovarian Cancer |
Drug: amifostine trihydrate Drug: carboplatin Drug: paclitaxel |
Phase II |
| Study Type: | Interventional |
| Study Design: | Supportive Care |
| Official Title: | Amifostine (Ethyol) as a Protectant in Metastatic Ovarian and Non-Small Cell Lung Cancer in Paclitaxel/Carboplatin-Treated Patients: A Comparative Trial |
| Estimated Enrollment: | 80 |
| Study Start Date: | May 1997 |
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.
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.
PROJECTED ACCRUAL: A total of 80 patients will be accrued (40 with advanced ovarian cancer and 40 with advanced non-small cell lung cancer) within 2 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically proven stage III/IV ovarian or non-small cell lung cancer
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
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
Contacts and Locations| United States, California | |
| Oncology Service of San Francisco General Hospital Medical Center | |
| San Francisco, California, United States, 94110 | |
| UCSF Cancer Center and Cancer Research Institute | |
| San Francisco, California, United States, 94115-0128 | |
| UCSF/Mt. Zion Cancer Center | |
| San Francisco, California, United States, 94115 | |
| Veterans Affairs Medical Center - San Francisco | |
| San Francisco, California, United States, 94121 | |
| Study Chair: | Robert J. Ignoffo, PharmD | University of California, San Francisco |
More Information
| Study ID Numbers: | CDR0000065752, UCSF-H57841348101A, ALZA-UCSF-H57841348101A, NCI-V97-1334 |
| Study First Received: | November 1, 1999 |
| Last Updated: | May 9, 2009 |
| ClinicalTrials.gov Identifier: | NCT00003072 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage III non-small cell lung cancer stage III ovarian epithelial cancer stage IV ovarian epithelial cancer stage IV non-small cell lung cancer neurotoxicity |
|
Thoracic Neoplasms Radiation-Protective Agents Molecular Mechanisms of Pharmacological Action Neurotoxicity Syndromes Antineoplastic Agents Gonadal Disorders Physiological Effects of Drugs Disorders of Environmental Origin Urogenital Neoplasms Ovarian Diseases Genital Diseases, Female Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses |
Endocrine Gland Neoplasms Respiratory Tract Neoplasms Neoplasms by Histologic Type Ovarian Neoplasms Amifostine Mitosis Modulators Nervous System Diseases Genital Neoplasms, Female Poisoning Endocrine System Diseases Antimitotic Agents Carboplatin Protective Agents Pharmacologic Actions Carcinoma |
