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Sponsored by: |
University of Alabama at Birmingham |
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Information provided by: | University of Alabama at Birmingham |
ClinicalTrials.gov Identifier: | NCT00584857 |
This is a study to determine the optimal treatment for patients with advanced stage or recurrent endometrial cancer. Traditionally, patients have been treated with either hormonal therapies (megesterol) or chemotherapy (paclitaxel and carboplatin). This study investigates the effectiveness of the combination of hormonal therapy and chemotherapy. This study also will examine the side-effects associated with these drugs and the quality of life of patients on combination therapy.
Condition | Intervention | Phase |
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Uterine Cancer |
Drug: Paclitaxel ,Carboplatin , Megesterol Acetate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Study of Combination Therapy With Paclitaxel, Carboplatin and Megesterol Acetate for the Management of Advanced Stage or Recurrent Carcinoma of the Endometrium |
Enrollment: | 35 |
Study Start Date: | July 2004 |
Estimated Study Completion Date: | May 2010 |
Estimated Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
Single
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Drug: Paclitaxel ,Carboplatin , Megesterol Acetate
Paclitaxel will be administered at an appropriate dose (175mg/m2) as a 3 hour continuous IV infusion every 21 days. Carboplatin will be administered at an appropriate dose utilizing Calvert formula for determining the area under the curve (AUC) based on the patient's glomerular filtration rate. Megesterol Acetate will be given orally four times a day at an anti-tumor dosage of 40 mg. This will be given for a total of 6 cycles over 18 weeks with the Megace continuing for 5 years as long as no evidence of recurrence is present.
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Ages Eligible for Study: | 19 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients with recurrent disease must have disease confirmed by one of the following:
Patients must have adequate organ function defined as:
Exclusion Criteria:
United States, Alabama | |
UAB Highlands, 1201 11th Ave S, 4th Floor, Gynecologic Oncology | |
Birmingham, Alabama, United States, 35205 |
Principal Investigator: | John M. Straughn, MD | University of Alabama at Birmingham |
Responsible Party: | UAB ( J. Michael Straughn, M.D, Assistant Professor Department of OB/GYN, Division of GYN Oncology ) |
Study ID Numbers: | F040628007, UAB 403 |
Study First Received: | December 21, 2007 |
Last Updated: | September 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00584857 |
Health Authority: | United States: Food and Drug Administration |
Genital Diseases, Female Paclitaxel Genital Neoplasms, Female Uterine Diseases Uterine Neoplasms Urogenital Neoplasms |
Carboplatin Endometrial cancer Megestrol Megestrol Acetate Recurrence Carcinoma |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses |
Mitosis Modulators Tubulin Modulators Antimitotic Agents Antineoplastic Agents, Phytogenic Pharmacologic Actions |