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

PURPOSE: Phase II trial to study the effectiveness of amifostine in reducing pain, numbness, tingling, and other symptoms of peripheral neuropathy in patients who have received paclitaxel for solid tumors.

Condition	Treatment or Intervention	Phase
adult solid tumor Breast Cancer Lung Cancer neurotoxicity ovarian epithelial cancer Prostate Cancer	Drug: amifostine  Procedure: chemoprotection  Procedure: complications of therapy assessment/management  Procedure: neurotoxicity attenuation  Procedure: supportive care/therapy	Phase II

OBJECTIVES: Primary

• Determine the percentage of patients with solid tumors who have persistent paclitaxel-induced peripheral neuropathy who benefit, defined as a decrease of at least 20% on their FACT-GOG-NTX score, from treatment with subcutaneous amifostine.
• Determine whether there is sufficient evidence of reversal activity of this drug in these patients to justify a phase III study.

Secondary

• Compare the acute toxic effects of this drug administered subcutaneously in these patients vs IV administrations of this drug historically and/or during the GOG-0192 study.
• Determine the capability of the Weinstein Enhanced Sensory Test to provide objective, quantitative evidence for improvement in patients who have subjective improvement as self-reported on the FACT-GOG-NTX scale.
• Determine whether any benefit in patients treated with this drug is transient or lasts at least 8 weeks.

OUTLINE: This is an open-label, multicenter study.

Patients receive amifostine subcutaneously three times weekly for 4 weeks in the absence of symptom progression or unacceptable toxicity. Patients achieving a complete or partial response receive an additional 4 weeks of therapy.

Neuropathy symptoms are assessed using the FACT-GOG-NTX questionnaire administered at baseline, weekly during therapy, and at 12 weeks and the Weinstein Enhanced Sensory Test administered at baseline and at 4, 8, and 12 weeks.

Patients are followed at 12 weeks.

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 10-20 months.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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
• 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 prior amifostine
• No concurrent monoamine oxidase inhibitors

Texas
      University of Texas M.D. Anderson CCOP Research Base, Houston,  Texas,  77030-4009,  United States; Recruiting

Study chairs or principal investigators

W. Archie Bleyer, MD,  Study Chair,  M.D. Anderson Cancer Center   

Study ID Numbers:  CDR0000330006; MDA-CCC-0223; MDA-CCC-0203; MDA-2003-0789
Record last reviewed:  May 2004
Record first received:  March 8, 2004
ClinicalTrials.gov Identifier:  NCT00078845
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2004-11-05