CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 30 enrolled
Drug / intervention
Paclitaxel ,Carboplatin , Megesterol Acetatedrug
Likely dose
Paclitaxel ,Carboplatin , Megesterol Acetate 175mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00584857
NCT00584857Phase 2Completed
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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

University of Alabama at Birmingham·interventional·Posted Jan 2, 2008·Updated Jan 27, 2017

In Brief

A Phase 2 clinical trial evaluating Paclitaxel ,Carboplatin , Megesterol Acetate for Uterine Cancer. Completed, enrolled 30 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUterine Cancer
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 2, 2008
Enrollment StartJul 1, 2004
Primary CompletionOct 1, 2010
Study CompletionOct 1, 2011
TodayJul 2, 2026
Enrollment to primary: 6.3 yearsPosted 18.5 years ago

Interventions

Paclitaxel ,Carboplatin , Megesterol Acetatedrug

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.