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Sponsors and Collaborators: |
Gynecologic Oncology Group National Cancer Institute (NCI) |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00005830 |
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. Combining chemotherapy with radiation therapy may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating women who have stage III or stage IV endometrial cancer.
Condition | Intervention | Phase |
Endometrial Cancer |
Drug: cisplatin Drug: doxorubicin hydrochloride Procedure: adjuvant therapy Procedure: radiation therapy |
Phase I |
MedlinePlus related topics: | Cancer |
ChemIDplus related topics: | Doxorubicin Doxorubicin hydrochloride Cisplatin |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase I Toxicity Trial of Doxorubicin-Cisplatin Followed by Whole Abdominal Irradiation for Advanced Endometrial Carcinoma |
Estimated Enrollment: | 53 |
Study Start Date: | July 2000 |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive doxorubicin IV and cisplatin IV on day 1. Treatment repeats every 3 weeks for 3 courses. Patients then undergo whole abdominal radiotherapy 5 days a week for 4-6 weeks.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 21-53 patients will be accrued for this study within 3.5 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed endometrial cancer including 1 of the following subtypes:
Stage III or IV disease
Tumor must be surgically reduced to 2 cm or less within 8 weeks of study entry
No distant metastases outside of abdominopelvic area, including:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
United States, Illinois | |||||
University of Chicago Cancer Research Center | |||||
Chicago, Illinois, United States, 60637-1470 | |||||
United States, Indiana | |||||
Indiana University Cancer Center | |||||
Indianapolis, Indiana, United States, 46202-5289 | |||||
United States, Ohio | |||||
Case Comprehensive Cancer Center | |||||
Cleveland, Ohio, United States, 44106 | |||||
Lake/University Ireland Cancer Center | |||||
Mentor, Ohio, United States, 44060 | |||||
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, 98195-6043 |
Gynecologic Oncology Group |
National Cancer Institute (NCI) |
Study Chair: | Jeffrey M. Fowler, MD | Arthur G. James Cancer Hospital & Richard J. Solove Research Institute |
Investigator: | Perry W. Grigsby, MD | St. Louis Children's Hospital |
Investigator: | William P. McGuire, MD | Harry & Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Fowler JM, Brady WE, Cohn DE, et al.: Sequential chemotherapy and irradiation in advanced-stage endometrial cancer: a Gynecologic Oncology Group phase I trial of doxorubicin-cisplatin followed by whole-abdomen irradiation. [Abstract] Society of Gynecologic Oncologists, 2007 Annual Meeting on Women's Cancer, March 3-7, 2007, San Diego, CA. A-230, 2007.
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Study ID Numbers: | CDR0000067844, GOG-9908 |
First Received: | June 2, 2000 |
Last Updated: | June 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00005830 |
Health Authority: | United States: Federal Government |
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