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Sponsors and Collaborators: |
Gynecologic Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00005840 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of combination chemotherapy when given with radiation therapy in treating patients with stage III or stage IV endometrial cancer.
Condition | Intervention | Phase |
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Endometrial Cancer |
Drug: cisplatin Drug: paclitaxel Procedure: adjuvant therapy Radiation: radiation therapy |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase I Trial of the Treatment of Advanced Endometrial Cancer With Concurrent Weekly Paclitaxel and Cisplatin and Whole Abdominal Radiation Therapy |
Study Start Date: | July 2000 |
OBJECTIVES:
OUTLINE: This is a dose-escalation study of paclitaxel and cisplatin.
Patients receive paclitaxel IV over 1 hour and cisplatin IV on days 1, 8, 15, 22, 29, and 36. Patients also undergo whole abdominal radiotherapy for 5 consecutive days weekly for 6 weeks.
Cohorts of 3-6 patients receive escalating doses of paclitaxel and cisplatin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are treated at that dose level.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 3-48 patients will be accrued for part I and 14-20 patients will be accrued for part II of this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Tumor must be surgically reduced to 2 cm or less within 8 weeks of study
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, Illinois | |
University of Chicago Cancer Research Center | |
Chicago, Illinois, United States, 60637-1470 | |
United States, Iowa | |
Holden Comprehensive Cancer Center at University of Iowa | |
Iowa City, Iowa, United States, 52242-1002 | |
United States, Missouri | |
Siteman Cancer Center at Barnes-Jewish Hospital | |
St Louis, Missouri, United States, 63110 | |
United States, Ohio | |
Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University | |
Cleveland, Ohio, United States, 44106 | |
Lake/University Ireland Cancer Center | |
Mentor, Ohio, United States, 44060 | |
United States, Oklahoma | |
Cancer Care Associates - Midtown Tulsa | |
Tulsa, Oklahoma, United States, 74104 | |
Oklahoma University Medical Center | |
Oklahoma City, Oklahoma, United States, 73104 | |
United States, Pennsylvania | |
Abramson Cancer Center of the University of Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19104 | |
United States, Washington | |
Fred Hutchinson Cancer Research Center | |
Seattle, Washington, United States, 98104 | |
University Cancer Center at University of Washington Medical Center | |
Seattle, Washington, United States, 98195 | |
United States, Wisconsin | |
University of Wisconsin Comprehensive Cancer Center | |
Madison, Wisconsin, United States, 53792 |
Study Chair: | D. Scott McMeekin, MD | Oklahoma University Cancer Institute |
Study ID Numbers: | CDR0000067856, GOG-9907 |
Study First Received: | June 2, 2000 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00005840 History of Changes |
Health Authority: | United States: Federal Government |
stage III endometrial carcinoma stage IV endometrial carcinoma endometrial papillary carcinoma endometrial clear cell carcinoma |
Genital Neoplasms, Female Adjuvants, Immunologic Uterine Diseases Urogenital Neoplasms Endometrial Cancer Antimitotic Agents Carcinoma Genital Diseases, Female Endometrial Neoplasms |
Adenocarcinoma, Clear Cell Radiation-Sensitizing Agents Cisplatin Paclitaxel Tubulin Modulators Carcinoma, Papillary Uterine Neoplasms Antineoplastic Agents, Phytogenic |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Mitosis Modulators Physiological Effects of Drugs Genital Neoplasms, Female Uterine Diseases Urogenital Neoplasms Antimitotic Agents Pharmacologic Actions Genital Diseases, Female |
Endometrial Neoplasms Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Cisplatin Paclitaxel Therapeutic Uses Tubulin Modulators Uterine Neoplasms Antineoplastic Agents, Phytogenic |