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Home > "A" Clinical Trials Conditions > Amifostine in Treating Patients With Ovarian Epithelial Cancer Who Are Receiving Chemotherapy  Amifostine in Treating Patients With Ovarian Epithelial Cancer Who Are Receiving Chemotherapy
Amifostine in Treating Patients With Ovarian Epithelial Cancer Who Are Receiving Chemotherapy
For Condition: stage 1 ovarian epithelial cancer,stage 3 ovarian epithelial cancer,stage 2 ovarian epithelial cancer,stage 4 ovarian epithelial cancer,Quality of Life
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Robert H. Lurie Cancer Center
Synopsis: 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: Randomized phase III trial to study the effectiveness of amifostine in treating patients who have ovarian epithelial cancer and who are receiving chemotherapy.
Details: OBJECTIVES: I. Determine if patients with ovarian epithelial cancer receiving chemotherapy have significantly fewer neurologic events when treated with amifostine. II. Compare amifostine vs no chemoprotection in terms of overall incidence of neuropathy, incidence of neutropenia, infection, and other myelosuppressive events (e.g., leukopenia, anemia, and thrombocytopenia), length of hospital stay due to infections, and quality of life in this patient population. PROTOCOL OUTLINE: This is a randomized, parallel, controlled, double blind study. Patients are randomized to one of two treatment arms. Arm I: Patients receive amifostine IV over 10 minutes, 30 minutes prior to chemotherapy. Arm II: Patients receive a placebo IV over 10 minutes, 30 minutes prior to chemotherapy. Treatment repeats every 3 weeks for 8 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed prior to courses 1, 4, and 8, and then every 3 months for 1 year. Patients are followed monthly for 6 months. PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 2 years.
Eligibility:
Study Type: Interventional, Educational/Counseling/Training
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed, surgically staged ovarian epithelial cancer - Planned treatment with paclitaxel/carboplatinum chemotherapy --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: See Disease Characteristics; No prior chemotherapy - Endocrine therapy: Not specified - Radiotherapy: No prior radiotherapy - Surgery: See Disease Characteristics - Other: At least 24 hours since prior antihypertensives --Patient Characteristics-- - Age: 18 and over - Performance status: GOG 0-2 - Life expectancy: Not specified - Hematopoietic: Absolute neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3 - Hepatic: Bilirubin no greater than 3 mg/dL; SGOT/SGPT no greater than 2.5 times upper limit of normal - Renal: Creatinine no greater than 2 mg/dL - Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception during and for 3 months after study
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DavidFishman, Study Chair, Robert H. Lurie Cancer Center
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, 60611
United States
Additional Information:
Study ID Numbers: CDR0000067410; NU-97CC4,NCI-G99-1633
Study Start Date: October 1999
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004166
Other Stage 3 Ovarian Epithelial Cancer Studies:
1. Irofulven in Treating Patients With Recurrent or Persistent Ovarian, Fallopian Tube, or Peritoneal Cancer
2. Combination Chemotherapy in Treating Patients With Primary Peritoneal or Stage III Epithelial Ovarian Cancer
3. Comparison of Combination Chemotherapy Regimens in Treating Newly Diagnosed Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer
4. Combination Chemotherapy Plus IM-862 in Treating Patients With Resected Stage III Ovarian Cancer or Primary Peritoneal Cancer
5. Monoclonal Antibody Therapy in Treating Patients With Stage III or Stage IV Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer
Related Studies:
Other stage 3 ovarian epithelial cancer Clinical Trials
Other Illinois Clinical Trials
Other Chicago Clinical Trials
Amifostine in Treating Patients With Ovarian Epithelial Cancer Who Are Receiving Chemotherapy
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