Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Gynecologic Oncology Group National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00058071 |
RATIONALE: Amifostine may be effective in relieving numbness, tingling, and other symptoms of peripheral neuropathy. It is not yet known whether amifostine is effective in treating peripheral neuropathy in patients who have received chemotherapy for cancer.
PURPOSE: This randomized phase III trial is studying amifostine to see how well it works compared to observation in relieving numbness, tingling, and other symptoms of peripheral neuropathy in patients who have received platinum-based chemotherapy (such as cisplatin or carboplatin) for cancer.
Condition | Intervention | Phase |
---|---|---|
Cancer-Related Problem/Condition Gestational Trophoblastic Tumor Unspecified Adult Solid Tumor, Protocol Specific |
Drug: amifostine trihydrate |
Phase III |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Active Control |
Official Title: | A Randomized Phase III Trial of Amifostine vs. No Treatment for Platinum Induced Peripheral Neuropathy |
Estimated Enrollment: | 100 |
Study Start Date: | March 2003 |
Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
Quality of life is assessed at baseline and then at 6, 12, 18, and 24 weeks after study entry.
Patients are followed at 6 and 12 weeks after study treatment, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 50-100 patients (25-50 per treatment arm) will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Prior therapy with platinum-based chemotherapy regimen for a malignancy
Grade 2 or greater peripheral neuropathy (numbness, tingling, pain in the distal extremities) attributed to prior platinum-based chemotherapy
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Study Chair: | Steven C. Plaxe, MD | University of California, San Diego |
Study ID Numbers: | CDR0000285700, GOG-0192 |
Study First Received: | April 7, 2003 |
Last Updated: | October 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00058071 |
Health Authority: | United States: Federal Government |
neurotoxicity hydatidiform mole unspecified adult solid tumor, protocol specific |
Gestational trophoblastic disease Pregnancy Complications Amifostine Neuromuscular Diseases Neurotoxicity Syndromes Neoplasms, Germ Cell and Embryonal |
Peripheral Nervous System Diseases Gestational Trophoblastic Neoplasms Neurotoxicity syndromes Hydatidiform Mole Trophoblastic Neoplasms Nevus |
Radiation-Protective Agents Neoplasms Pregnancy Complications, Neoplastic Neoplasms by Histologic Type |
Physiological Effects of Drugs Nervous System Diseases Protective Agents Pharmacologic Actions |