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| Sponsor: | Gynecologic Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003624 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cervical Cancer Endometrial Cancer Fallopian Tube Cancer Neurotoxicity Ovarian Cancer Peritoneal Cavity Cancer Sarcoma |
Drug: amifostine trihydrate Drug: cisplatin Drug: paclitaxel |
Phase II |
| Study Type: | Interventional |
| Study Design: | 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 |
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.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Ovarian, primary peritoneal, cervical, or fallopian tube carcinoma, uterine sarcoma, or endometrial adenocarcinoma for which the proposed treatment is cisplatin plus paclitaxel Must be ineligible for a higher priority GOG protocol
PATIENT CHARACTERISTICS: Age: Not specified Performance status: GOG 0-3 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) AST and alkaline phosphatase no greater than 3 times ULN Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No hypertension for which medication cannot be discontinued for 24 hours through the day of each chemotherapy treatment Other: No history of neuropathy (e.g., diabetic neuropathy) No significant infection Prior malignancy allowed if disease free for at least 12 months No physical disabilities precluding vibration perception threshold testing of the upper and lower extremity (e.g., amputation, paraplegia)
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for ovarian, primary peritoneal, or fallopian tube carcinoma, uterine sarcoma, or endometrial adenocarcinoma Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy except for cervical carcinoma Surgery: Not specified
Contacts and Locations| 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 |
More Information
| Study ID Numbers: | CDR0000066705, GOG-9805 |
| Study First Received: | November 1, 1999 |
| Last Updated: | May 9, 2009 |
| ClinicalTrials.gov Identifier: | NCT00003624 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage I cervical cancer stage II cervical cancer stage III cervical cancer stage IV cervical cancer stage I ovarian epithelial cancer stage II ovarian epithelial cancer stage III ovarian epithelial cancer stage IV ovarian epithelial cancer stage I endometrial carcinoma stage II endometrial carcinoma |
stage III endometrial carcinoma stage IV endometrial carcinoma endometrial adenocarcinoma fallopian tube cancer peritoneal cavity cancer stage I uterine sarcoma stage II uterine sarcoma stage III uterine sarcoma stage IV uterine sarcoma neurotoxicity |
|
Radiation-Protective Agents Molecular Mechanisms of Pharmacological Action Neurotoxicity Syndromes Antineoplastic Agents Gonadal Disorders Physiological Effects of Drugs Disorders of Environmental Origin Urogenital Neoplasms Ovarian Diseases Uterine Cervical Neoplasms Genital Diseases, Female Neoplasms, Connective and Soft Tissue Uterine Cervical Diseases Endometrial Neoplasms Neoplasms by Site |
Cisplatin Therapeutic Uses Peritoneal Diseases Uterine Neoplasms Endocrine Gland Neoplasms Neoplasms by Histologic Type Ovarian Neoplasms Digestive System Neoplasms Amifostine Mitosis Modulators Nervous System Diseases Poisoning Genital Neoplasms, Female Uterine Diseases Endocrine System Diseases |
