Amifostine in Treating Peripheral Neuropathy in Patients Who Have Received Chemotherapy for Cancer (NCT00058071) | Clinical Trial Compass
CompletedPhase 3
Amifostine in Treating Peripheral Neuropathy in Patients Who Have Received Chemotherapy for Cancer
United States100 participantsStarted 2003-03
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 concā¦
What they're measuring
1
Improvement of neuropathy by WEST assessment at 6, 12, 18, and 24 weeks