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

Breast Cancer Clinical Trial

Official title:

Phase II Trial Of Subcutaneous Amifostine For Reversal Of Persistent Paclitaxel-Induced Peripheral Neuropathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00078845
• Other study ID #: CDR0000330006
• Secondary ID: MDA-CCC-0223MDA-
• Status: Completed
• Phase: Phase 2
• First received: March 8, 2004
• Last updated: October 16, 2012
• Start date: May 2004
• Est. completion date: May 2007

Study information

• Verified date: October 2012
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breast Cancer
• Lung Cancer
• Neurotoxicity
• Neurotoxicity Syndromes
• Ovarian Cancer
• Peripheral Nervous System Diseases
• Prostate Cancer
• Prostatic Neoplasms
• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Drug:
• Amifostine
500 mg three times a week.

Locations

Country	Name	City	State
United States	Christus St. Frances Cabrini Center for Cancer Care	Alexandria	Louisiana
United States	CCOP - Columbus	Columbus	Ohio
United States	CCOP - Central Illinois	Decatur	Illinois
United States	CCOP - Grand Rapids	Grand Rapids	Michigan
United States	University of Texas M.D. Anderson CCOP Research Base	Houston	Texas
United States	CCOP - Kalamazoo	Kalamazoo	Michigan
United States	CCOP - Kansas City	Kansas City	Missouri
United States	CCOP - Marshfield Clinic Research Foundation	Marshfield	Wisconsin
United States	All Saints Cancer Center at Wheaton Franciscan Healthcare	Racine	Wisconsin
United States	CCOP - Upstate Carolina	Spartanburg	South Carolina
United States	Cancer Research for the Ozarks	Springfield	Missouri
United States	CCOP - Northwest	Tacoma	Washington
United States	CCOP - Scott and White Hospital	Temple	Texas
United States	CCOP - Carle Cancer Center	Urbana	Illinois
United States	CCOP - Wichita	Wichita	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neurotoxicity secondary to cancer therapy as measured by FACT-GOG-NTX scale	11-item FACT/GOG-NTX questionnaire completed weekly following chemotherapy treatment.	12 weeks	Yes