Oxaliplatin and Gemcitabine Followed by Radiation Therapy in the Management of Mixed Mullerian Tumors of the Uterus
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|ClinicalTrials.gov Identifier: NCT00476086|
Recruitment Status : Completed
First Posted : May 21, 2007
Results First Posted : April 13, 2016
Last Update Posted : August 24, 2018
|Condition or disease||Intervention/treatment||Phase|
|Mixed Mullerian Tumors of the Uterus||Drug: Gemcitabine Drug: Oxaliplatin Radiation: Radiation||Phase 2|
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).
* To describe the response rate by Response Evaluation Criteria in Solid Tumors
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Oxaliplatin and Gemcitabine Followed by Radiation Therapy in the Management of Mixed Mullerian Tumors of the Uterus|
|Study Start Date :||August 2006|
|Actual Primary Completion Date :||March 2012|
|Actual Study Completion Date :||December 2015|
Experimental: Oxaliplatin/ Gemcitabine Then Radiation
Patients rcvd IV chemotherapy on days 1 and 15 of a 4-week cycle: gemcitabine 1000 mg/m2 and oxaliplatin 65 mg/m2 for up to 3 cycles. Two dose reductions per study drug were permitted. On study, chemotherapy was followed by radiation therapy (RT) within 4-6 weeks of last chemotherapy. RT regimen was tumor-volume directed.
Other Name: Gemzar
Other Name: Eloxatin
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00476086
|United States, Massachusetts|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Susana Campos, MD||Dana-Farber Cancer Institute|