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