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Sponsors and Collaborators: |
M.D. Anderson Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00078845 |
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 Cancer-Related Problem/Condition Lung Cancer Ovarian Cancer Prostate Cancer Unspecified Adult Solid Tumor, Protocol Specific |
Drug: amifostine trihydrate |
Phase II |
Study Type: | Interventional |
Study Design: | Supportive Care, Open Label |
Official Title: | Phase II Trial Of Subcutaneous Amifostine For Reversal Of Persistent Paclitaxel-Induced Peripheral Neuropathy |
Estimated Enrollment: | 40 |
Study Start Date: | May 2004 |
OBJECTIVES:
Primary
Secondary
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 older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of a solid tumor, including, but not limited to the following:
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
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Illinois | |
CCOP - Carle Cancer Center | |
Urbana, Illinois, United States, 61801 | |
CCOP - Central Illinois | |
Decatur, Illinois, United States, 62526 | |
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 | |
Cancer Research for the Ozarks | |
Springfield, Missouri, United States, 65807 | |
CCOP - Kansas City | |
Kansas City, Missouri, United States, 64131 | |
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 | |
CCOP - Scott and White Hospital | |
Temple, Texas, United States, 76508 | |
University of Texas M.D. Anderson CCOP Research Base | |
Houston, Texas, United States, 77030-4009 | |
United States, Washington | |
CCOP - Northwest | |
Tacoma, Washington, United States, 98405-0986 | |
United States, Wisconsin | |
All Saints Cancer Center at Wheaton Franciscan Healthcare | |
Racine, Wisconsin, United States, 53405 | |
CCOP - Marshfield Clinic Research Foundation | |
Marshfield, Wisconsin, United States, 54449 |
Study Chair: | Arthur Forman, MD | M.D. Anderson Cancer Center |
Study ID Numbers: | CDR0000330006, MDA-CCC-0223, MDA-CCC-0203, MDA-2003-0789 |
Study First Received: | March 8, 2004 |
Last Updated: | October 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00078845 |
Health Authority: | United States: Federal Government |
neurotoxicity unspecified adult solid tumor, protocol specific recurrent prostate cancer stage I prostate cancer stage II 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 |
Thoracic Neoplasms Neurotoxicity Syndromes Genital Neoplasms, Male Prostatic Diseases Gonadal Disorders Urogenital Neoplasms Ovarian Diseases Ovarian epithelial cancer Genital Diseases, Female Respiratory Tract Diseases Neuromuscular Diseases Lung Neoplasms Breast Diseases Endocrine Gland Neoplasms Ovarian cancer |
Non-small cell lung cancer Ovarian Neoplasms Amifostine Skin Diseases Neurotoxicity syndromes Genital Neoplasms, Female Breast Neoplasms Endocrine System Diseases Genital Diseases, Male Recurrence Carcinoma, Small Cell Paclitaxel Lung Diseases Peripheral Nervous System Diseases Endocrinopathy |
Respiratory Tract Neoplasms Radiation-Protective Agents Neoplasms Neoplasms by Site Physiological Effects of Drugs |
Nervous System Diseases Protective Agents Pharmacologic Actions Adnexal Diseases |