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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00078845
First received: March 8, 2004
Last updated: October 16, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Lung Cancer
Neurotoxicity
Ovarian Cancer
Prostate Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Drug: Amifostine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Phase II Trial Of Subcutaneous Amifostine For Reversal Of Persistent Paclitaxel-Induced Peripheral Neuropathy

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Neurotoxicity secondary to cancer therapy as measured by FACT-GOG-NTX scale [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    11-item FACT/GOG-NTX questionnaire completed weekly following chemotherapy treatment.


Enrollment: 24
Study Start Date: May 2004
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Amifostine
500 mg subcutaneous three times a week on Monday, Wednesday and Friday for 4 weeks.
Drug: Amifostine
500 mg three times a week.
Other Name: amifostine trihydrate

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00078845

Locations
United States, Illinois
CCOP - Central Illinois
Decatur, Illinois, United States, 62526
CCOP - Carle Cancer Center
Urbana, Illinois, United States, 61801
United States, Kansas
CCOP - Wichita
Wichita, Kansas, United States, 67214-3882
United States, Louisiana
Christus St. Frances Cabrini Center for Cancer Care
Alexandria, Louisiana, United States, 71301
United States, Michigan
CCOP - Grand Rapids
Grand Rapids, Michigan, United States, 49503
CCOP - Kalamazoo
Kalamazoo, Michigan, United States, 49007-3731
United States, Missouri
CCOP - Kansas City
Kansas City, Missouri, United States, 64131
Cancer Research for the Ozarks
Springfield, Missouri, United States, 65807
United States, Ohio
CCOP - Columbus
Columbus, Ohio, United States, 43215
United States, South Carolina
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States, 29303
United States, Texas
University of Texas M.D. Anderson CCOP Research Base
Houston, Texas, United States, 77030-4009
CCOP - Scott and White Hospital
Temple, Texas, United States, 76508
United States, Washington
CCOP - Northwest
Tacoma, Washington, United States, 98405-0986
United States, Wisconsin
CCOP - Marshfield Clinic Research Foundation
Marshfield, Wisconsin, United States, 54449
All Saints Cancer Center at Wheaton Franciscan Healthcare
Racine, Wisconsin, United States, 53405
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Study Chair: Arthur Forman, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00078845     History of Changes
Other Study ID Numbers: CDR0000330006, MDA-CCC-0223, MDA-CCC-0203, MDA-2003-0789
Study First Received: March 8, 2004
Last Updated: October 16, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
neurotoxicity
unspecified adult solid tumor, protocol specific
recurrent prostate cancer
stage I prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer
stage III prostate cancer
stage IV prostate cancer
recurrent non-small cell lung cancer
stage I non-small cell lung cancer
stage II non-small cell lung cancer
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
limited stage small cell lung cancer
extensive stage small cell lung cancer
recurrent small cell lung cancer
recurrent breast cancer
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
stage IV breast cancer
recurrent ovarian epithelial cancer
stage I ovarian epithelial cancer
stage II ovarian epithelial cancer
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer

Additional relevant MeSH terms:
Breast Neoplasms
Lung Neoplasms
Ovarian Neoplasms
Peripheral Nervous System Diseases
Prostatic Neoplasms
Neurotoxicity Syndromes
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neuromuscular Diseases
Nervous System Diseases
Genital Neoplasms, Male
Genital Diseases, Male
Prostatic Diseases
Poisoning
Substance-Related Disorders
Amifostine

ClinicalTrials.gov processed this record on July 20, 2014