Amifostine in Treating Women With Ovarian, Peritoneal, Cervical, Fallopian Tube, Uterine, or Endometrial Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs, such as amifostine, may protect normal cells from the side effects of chemotherapy.
PURPOSE: Phase II trial to study the effectiveness of amifostine in reducing the risk of side effects caused by cisplatin and paclitaxel in treating women who have ovarian, peritoneal, cervical, fallopian tube, uterine, or endometrial cancer.
|Cervical Cancer Endometrial Cancer Fallopian Tube Cancer Neurotoxicity Ovarian Cancer Primary Peritoneal Cavity Cancer Sarcoma||Drug: amifostine trihydrate Drug: cisplatin Drug: paclitaxel||Phase 2|
|Study Design:||Primary Purpose: Supportive Care|
|Official Title:||A Limited Access Trial Using Amifostine for Protection Against Cisplatin and 3-Hour Paclitaxel-Induced Neurotoxicity|
|Study Start Date:||December 1998|
|Primary Completion Date:||January 2004 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Determine the efficacy of amifostine in reducing significant peripheral neuropathy in women with ovarian, peritoneal, cervical, fallopian tube, uterine, or endometrial cancer treated with cisplatin and paclitaxel. II. Determine the proportion of patients on this regimen who experience significant peripheral neuropathy 3 months after completing chemotherapy. III. Assess the overall toxicity of this regimen in these patients.
OUTLINE: Patients receive paclitaxel IV over 3 hours, amifostine IV over 10 minutes, and cisplatin IV over 90 minutes. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Neurotoxicity is assessed and vibration perception threshold testing is performed prior to each course of chemotherapy and at 3 months following the last treatment. Patients are followed every 3 months for 2 years, then every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 29-59 patients will be accrued for this study within 18-36 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003624
|United States, California|
|Chao Family Comprehensive Cancer Center|
|Orange, California, United States, 92868|
|United States, District of Columbia|
|Vincent T. Lombardi Cancer Research Center, Georgetown University|
|Washington, District of Columbia, United States, 20007|
|United States, Georgia|
|Emory University Hospital - Atlanta|
|Atlanta, Georgia, United States, 30322|
|United States, Illinois|
|University of Chicago Cancer Research Center|
|Chicago, Illinois, United States, 60637|
|United States, Indiana|
|Indiana University Cancer Center|
|Indianapolis, Indiana, United States, 46202-5265|
|United States, Missouri|
|Washington University School of Medicine|
|Saint Louis, Missouri, United States, 63110|
|United States, North Carolina|
|Lineberger Comprehensive Cancer Center, UNC|
|Chapel Hill, North Carolina, United States, 27599-7295|
|United States, Ohio|
|Cleveland Clinic Cancer Center|
|Cleveland, Ohio, United States, 44195|
|Study Chair:||David H. Moore, MD||Indiana University Melvin and Bren Simon Cancer Center|