Amifostine in Treating Peripheral Neuropathy Caused by Paclitaxel in Patients With Solid Tumors
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00078845|
Recruitment Status : Completed
First Posted : March 9, 2004
Last Update Posted : October 17, 2012
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 or disease||Intervention/treatment||Phase|
|Breast Cancer Lung Cancer Neurotoxicity Ovarian Cancer Prostate Cancer Unspecified Adult Solid Tumor, Protocol Specific||Drug: Amifostine||Phase 2|
- 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.
- 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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Phase II Trial Of Subcutaneous Amifostine For Reversal Of Persistent Paclitaxel-Induced Peripheral Neuropathy|
|Study Start Date :||May 2004|
|Primary Completion Date :||May 2007|
|Study Completion Date :||May 2007|
500 mg subcutaneous three times a week on Monday, Wednesday and Friday for 4 weeks.
500 mg three times a week.
Other Name: amifostine trihydrate
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00078845
|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|
|Study Chair:||Arthur Forman, MD||M.D. Anderson Cancer Center|