- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00078845
Amifostine in Treating Peripheral Neuropathy Caused by Paclitaxel in Patients With Solid Tumors
Phase II Trial Of Subcutaneous Amifostine For Reversal Of Persistent Paclitaxel-Induced Peripheral Neuropathy
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Illinois
-
Decatur, Illinois, United States, 62526
- CCOP - Central Illinois
-
Urbana, Illinois, United States, 61801
- CCOP - Carle Cancer Center
-
-
Kansas
-
Wichita, Kansas, United States, 67214-3882
- CCOP - Wichita
-
-
Louisiana
-
Alexandria, Louisiana, United States, 71301
- Christus St. Frances Cabrini Center for Cancer Care
-
-
Michigan
-
Grand Rapids, Michigan, United States, 49503
- CCOP - Grand Rapids
-
Kalamazoo, Michigan, United States, 49007-3731
- CCOP - Kalamazoo
-
-
Missouri
-
Kansas City, Missouri, United States, 64131
- CCOP - Kansas City
-
Springfield, Missouri, United States, 65807
- Cancer Research for the Ozarks
-
-
Ohio
-
Columbus, Ohio, United States, 43215
- CCOP - Columbus
-
-
South Carolina
-
Spartanburg, South Carolina, United States, 29303
- CCOP - Upstate Carolina
-
-
Texas
-
Houston, Texas, United States, 77030-4009
- University of Texas M.D. Anderson CCOP Research Base
-
Temple, Texas, United States, 76508
- CCOP - Scott and White Hospital
-
-
Washington
-
Tacoma, Washington, United States, 98405-0986
- CCOP - Northwest
-
-
Wisconsin
-
Marshfield, Wisconsin, United States, 54449
- CCOP - Marshfield Clinic Research Foundation
-
Racine, Wisconsin, United States, 53405
- All Saints Cancer Center at Wheaton Franciscan Healthcare
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Amifostine
500 mg subcutaneous three times a week on Monday, Wednesday and Friday for 4 weeks.
|
500 mg three times a week.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neurotoxicity secondary to cancer therapy as measured by FACT-GOG-NTX scale
Time Frame: 12 weeks
|
11-item FACT/GOG-NTX questionnaire completed weekly following chemotherapy treatment.
|
12 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Arthur Forman, MD, M.D. Anderson Cancer Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- stage IV breast cancer
- stage IIIA breast cancer
- recurrent breast cancer
- stage IIIB breast cancer
- recurrent non-small cell lung cancer
- extensive stage small cell lung cancer
- recurrent small cell lung cancer
- stage III prostate cancer
- stage IV prostate cancer
- recurrent prostate cancer
- stage IIIA non-small cell lung cancer
- stage IIIB non-small cell lung cancer
- stage IV non-small cell lung cancer
- unspecified adult solid tumor, protocol specific
- stage I non-small cell lung cancer
- stage II non-small cell lung cancer
- stage III ovarian epithelial cancer
- stage IV ovarian epithelial cancer
- recurrent ovarian epithelial cancer
- stage II breast cancer
- stage IIIC breast cancer
- neurotoxicity
- stage I breast cancer
- limited stage small cell lung cancer
- stage I prostate cancer
- stage IIB prostate cancer
- stage IIA prostate cancer
- stage I ovarian epithelial cancer
- stage II ovarian epithelial cancer
Additional Relevant MeSH Terms
- Chemically-Induced Disorders
- Nervous System Diseases
- Skin Diseases
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Urogenital Neoplasms
- Neoplasms by Site
- Genital Neoplasms, Male
- Breast Diseases
- Prostatic Diseases
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Neuromuscular Diseases
- Poisoning
- Breast Neoplasms
- Prostatic Neoplasms
- Lung Neoplasms
- Peripheral Nervous System Diseases
- Neurotoxicity Syndromes
- Physiological Effects of Drugs
- Protective Agents
- Radiation-Protective Agents
- Amifostine
Other Study ID Numbers
- CDR0000330006
- MDA-CCC-0223
- MDA-CCC-0203
- MDA-2003-0789
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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