Amifostine in Treating Peripheral Neuropathy Caused by Paclitaxel in Patients With Solid Tumors

• Status: Completed
• Trial end date: 2007-05-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Amifostine may be effective in reducing pain, numbness, tingling, and other symptoms of peripheral neuropathy.

PURPOSE: This phase II trial is studying how well amifostine works in reducing pain, numbness, tingling, and other symptoms of peripheral neuropathy in patients who have received paclitaxel for solid tumors.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Amifostine; Paclitaxel

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of a solid tumor, including, but not limited to the following:

• Ovarian cancer

• Lung cancer

• Prostate cancer

• Breast cancer

• Previously treated with paclitaxel

• Peripheral neuropathy (e.g., numbness, tingling, and/or pain in distal extremities) believed to be caused by paclitaxel only or the combination of paclitaxel and carboplatin

• At least 18 out of 44 on the FACT-GOG-NTX scale

• Persistent neuropathy for at least 2, but no more than 12 months after chemotherapy

• Not improving

• No other possible cause of neuropathy (e.g., alcoholism, diabetes, or peripheral vascular disease)

• Hormone receptor status:

• Not specified

PATIENT CHARACTERISTICS:

Age

• 18 and over

Sex

• Not specified

Menopausal status

• Not specified

Performance status

• Karnofsky 50-100%

Life expectancy

• More than 2 months

Hematopoietic

• Not specified

Hepatic

• Bilirubin ≤ 2.0 mg/dL

Renal

• Creatinine ≤ 2.0 mg/dL

• Calcium ≥ lower limit of normal

Cardiovascular

• See Disease Characteristics

• No prior cerebrovascular accident

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No other significant comorbid medical condition that would preclude study participation

• No known sensitivity to aminothiol compounds

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• See Disease Characteristics

• No prior cisplatin

• No chemotherapy during and for at least 3 months after study participation

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• No concurrent monoamine oxidase inhibitors