Oxaliplatin and Gemcitabine Followed by Radiation Therapy in the Management of Mixed 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.

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