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Combination Chemotherapy in Treating Patients With Metastatic Ovarian Cancer or Non-small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00003072
Recruitment Status : Completed
First Posted : September 6, 2004
Last Update Posted : September 21, 2012
Information provided by:
University of California, San Francisco

Brief Summary:

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 or disease Intervention/treatment Phase
Lung Cancer Neurotoxicity Ovarian Cancer Drug: amifostine trihydrate Drug: carboplatin Drug: paclitaxel Phase 2

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Primary Purpose: 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
Study Start Date : May 1997
Actual Primary Completion Date : October 1998
Actual Study Completion Date : October 1998

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00003072

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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
Sponsors and Collaborators
University of California, San Francisco
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Study Chair: Robert J. Ignoffo, PharmD University of California, San Francisco
Layout table for additonal information Identifier: NCT00003072    
Other Study ID Numbers: CDR0000065752
First Posted: September 6, 2004    Key Record Dates
Last Update Posted: September 21, 2012
Last Verified: September 2012
Keywords provided by University of California, San Francisco:
stage III non-small cell lung cancer
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
stage IV non-small cell lung cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Neurotoxicity Syndromes
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Nervous System Diseases
Chemically-Induced Disorders
Antineoplastic Agents, Phytogenic