Amifostine in Treating Peripheral Neuropathy in Patients Who Have Received Chemotherapy for Cancer
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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 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 |
|---|---|---|
|
Gestational Trophoblastic Tumor Neurotoxicity Peripheral Neuropathy Unspecified Adult Solid Tumor, Protocol Specific |
Drug: amifostine trihydrate |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Supportive Care |
| Official Title: | A Randomized Phase III Trial of Amifostine vs. No Treatment for Platinum Induced Peripheral Neuropathy |
- Improvement of neuropathy by WEST assessment at 6, 12, 18, and 24 weeks
- Improved quality of life by Functional Assessment of Cancer Therapy-GOG/NTX (FACT-GOG/NTX) at 6, 12, 18, and 24 weeks
| Estimated Enrollment: | 100 |
| Study Start Date: | March 2003 |
| Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- Determine, preliminarily, whether amifostine is superior to no treatment, in terms of improving the symptoms and/or objective findings of platinum-induced peripheral neuropathy, in patients with cancer.
- Determine the toxicity of this drug in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive amifostine IV or subcutaneously over 3 minutes on days 1, 3, and 5. Treatment continues for 12 weeks in the absence of unacceptable toxicity. Patients are observed for 12 weeks.
- Arm II: Patients are observed for 24 weeks. After 24 weeks patients may cross over to treatment as in arm I.
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.
Eligibility| 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
- Treatment with other agents, including paclitaxel, allowed
Grade 2 or greater peripheral neuropathy (numbness, tingling, pain in the distal extremities) attributed to prior platinum-based chemotherapy
- Must have persisted and be stable for 3-36 months after completion of chemotherapy
- Duration of neuropathy no more than 3 years
- No other possible causes for the neuropathy (e.g., alcoholism, diabetes, or peripheral vascular disease)
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- GOG 0-3
Life expectancy
- At least 6 months
Hematopoietic
- Not specified
Hepatic
- Bilirubin no greater than 2.0 mg/dL
Renal
- Creatinine no greater than 2.0 mg/dL
- Calcium at least lower limit of normal
Cardiovascular
- No hypotension
- No history of cerebrovascular accident
Other
- No other significant comorbid medical conditions that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- See Disease Characteristics
- No concurrent chemotherapy
- No chemotherapy (including paclitaxel, cisplatin, and carboplatin) for at least 4 months after study entry
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Other
- At least 24 hours since prior antihypertensive medications
- No prior amifostine
- Prior treatment on a GOG treatment protocol allowed
- No concurrent monoamine oxidase inhibitors
- No concurrent neurotoxic agents during and for at least 6 months after study entry
Contacts and Locations
Show 57 Study Locations| Study Chair: | Steven C. Plaxe, MD | University of California, San Diego |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00058071 History of Changes |
| Other Study ID Numbers: | CDR0000285700, GOG-0192 |
| Study First Received: | April 7, 2003 |
| Last Updated: | May 6, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
peripheral neuropathy neurotoxicity hydatidiform mole unspecified adult solid tumor, protocol specific |
Additional relevant MeSH terms:
|
Peripheral Nervous System Diseases Trophoblastic Neoplasms Neurotoxicity Syndromes Demyelinating Diseases Polyneuropathies Nerve Compression Syndromes Neurologic Manifestations Gestational Trophoblastic Neoplasms Neuromuscular Diseases Nervous System Diseases Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type |
Neoplasms Pregnancy Complications, Neoplastic Pregnancy Complications Poisoning Substance-Related Disorders Signs and Symptoms Amifostine Radiation-Protective Agents Protective Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013