Clinical Trial: Oxaliplatin and Gemcitabine Followed by Radiation Therapy in the Management of Mixed Mullerian Tumors of the Uterus

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase II Study of Oxaliplatin and Gemcitabine Followed by Radiation Therapy in the Management of Mixed Mullerian Tumors of the Uterus

Brief Summary: The purpose of this research study is to determine the feasibility and safety of giving the combination of oxaliplatin and gemcitabine followed by radiation therapy and to learn whether or not this drug combined with radiation therapy works in treating women with Mullerian tumors of the uterus.

Detailed Summary:

OBJECTIVES:

Primary To determine the feasibility of dual modality therapy described as cytotoxic therapy followed by radiation therapy for the management of Malignant Mixed Mullerian Tumors (MMMTs).

Secondary

* To describe the response rate by Response Evaluation Criteria in Solid Tumors

STATISTICAL DESIGN:

This study used a two-stage design to evaluate feasibility of oxaliplatin and gemcitabine prior to radiation therapy defined as completing 3 cycles of chemotherapy. The null and alternative therapy completion rates were 25% and 50%. If 3 or more participants enrolled in the stage one cohort (n=9 participants) complete therapy than accrual would proceed to stage two (n=15 participants). If therapy was completed by at least 10 participants in the final set of 24 evaluable participants then this regimen would be deemed worthy of further study. This design had 80% power given one-sided type I error of 5% with the probability of stopping early 0.60.


Sponsor: Dana-Farber Cancer Institute

Current Primary Outcome: Chemotherapy Completion Rate [ Time Frame: 3 cycles of chemotherapy which approximates 3 months given the 28-day cycle ]

Feasibility in this study was based on the chemotherapy regimen. The chemotherapy completion rate is defined as the percentage of patients who complete 3 cycles of oxaliplatin and gemcitabine chemotherapy prior to radiation therapy.


Original Primary Outcome: To determine the feasibility of dual modality therapy described as cytotoxic therapy followed by radiation therapy for the management of MMMTs.

Current Secondary Outcome: Radiation Therapy Completion Rate [ Time Frame: Radiation therapy was within 4-6 weeks of last chemotherapy dose. Participants received up to 5 weeks of radiation therapy. ]

Disease was evaluated radiologically at baseline and every X cycles on treatment; Treatment continued if radiological exam showed no progressive disease


Original Secondary Outcome: To describe (1) the response rate by RECIST criteria per stage (2) time to progression (3) the safety profile of dual modality treatment.

Information By: Dana-Farber Cancer Institute

Dates:
Date Received: May 17, 2007
Date Started: August 2006
Date Completion:
Last Updated: May 5, 2016
Last Verified: May 2016