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

M.D. Anderson Cancer Center

Status and phase: Completed; Phase 2

Conditions: Breast Cancer; Unspecified Adult Solid Tumor, Protocol Specific; Lung Cancer; Ovarian Cancer; Prostate Cancer; Neurotoxicity

Treatments: Drug: Amifostine

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00078845

CDR0000330006

MDA-2003-0789

MDA-CCC-0223

MDA-CCC-0203

Details and patient eligibility

About

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.

Full description

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 FUNCTIONAL ASSESSMENT OF CANCER THERAPY/ GYNECOLOGIC ONCOLOGY GROUP NEUROTOXICITY (FACT/GOG-Ntx) 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.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Amifostine

Experimental group

Description:

500 mg subcutaneous three times a week on Monday, Wednesday and Friday for 4 weeks.

Treatment:

Drug: Amifostine