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