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

Phase 2

Completed

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 Description: 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.

Recruitment & Eligibility

Inclusion Criteria

Surgically staged and histologically confirmed diagnosis of MMMT
18 years of age or older
ECOG Performance Score of 0-2
Adequate bone marrow function
Adequate renal function
Adequate hepatic function
Patients must be recovered from both the acute and late effects of any prior surgery

Exclusion Criteria

Patients with an active infection
Patients with CNS metastases
History of prior malignancy within the past 5 years except curatively treated basal cell carcinoma of the skin, or cervical intraepithelial neoplasia
Known hypersensitivity to any of the components of oxaliplatin or gemcitabine
Prior radiation to the pelvis
Patients who are receiving concurrent investigational therapy or who have received investigational therapy within 30 days
Peripheral neuropathy greater or equal to Grade 2
Stage IV visceral disease (lung and liver metastases at presentation)
Any other medical condition, including mental illness or substance abuse, deemed by the investigator to be likely to interfere with a patient's ability to sign informed consent
Known HIV or Hepatitis B or C (active, previously treated or both)
Pregnant or breast feeding

Arm && Interventions

Group	Intervention	Description
Oxaliplatin/ Gemcitabine Then Radiation	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.
Oxaliplatin/ Gemcitabine Then Radiation	Gemcitabine	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.
Oxaliplatin/ Gemcitabine Then Radiation	Oxaliplatin	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.

Primary Outcome Measures

Name	Time	Method
Chemotherapy Completion Rate	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.

Secondary Outcome Measures

Name	Time	Method
Radiation Therapy Completion Rate	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

Locations (2): Dana-Farber Cancer Institute
🇺🇸
Boston, Massachusetts, United States
Massachusetts General Hospital
🇺🇸
Boston, Massachusetts, United States