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Amifostine in Treating Peripheral Neuropathy in Patients Who Have Received Chemotherapy for Gynecologic Malignancy
This study is currently recruiting patients.
| Sponsored by: | Gynecologic Oncology Group |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
Purpose
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 gynecologic malignancy.
PURPOSE: Randomized phase III trial to study the effectiveness of amifostine in relieving numbness, tingling, and other symptoms of peripheral neuropathy in patients who have undergone platinum-based chemotherapy (such as cisplatin or carboplatin) for gynecologic cancer.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Endocrine Cancer female reproductive cancer neurotoxicity |
Drug: amifostine Procedure: chemoprotection Procedure: neurotoxicity attenuation Procedure: supportive care/therapy |
Phase III |
MedlinePlus related topics: Cancer; Cancer Alternative Therapy; Endocrine Diseases; Poisoning; Reproductive Health
Study Type: Interventional
Study Design: Treatment
Official Title: Phase III Randomized Study of Amifostine Versus No Treatment For Platinum-Induced Peripheral Neuropathy in Patients With Gynecologic Malignancies
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
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.
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Location
and Contact
Information
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
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