A Phase II Study of Therapy With Paclitaxel, Carboplatin and Megesterol Acetate for the Management of Uterine Cancer

Inclusion Criteria

• Patients must have biopsy proven endometrioid adenocarcinoma or adenosquamous carcinoma.
• Patients must have evidence of primary FIGO Stage III-IVB or recurrent endometrial cancer.
• Patients with non-measurable disease following complete cytoreduction at the time of initial operative management for Stage III-IVB are eligible.
• Patients with recurrent disease must have disease confirmed by one of the following:
• CT Scan
• MRI
• PET Scan
• Physical Exam
• Patients must have adequate organ function defined as:
• Platelets >/= 100,000/1
• Granulocytes (ANC) >/= 1,500/
• Creatinine </= 1.6mg/dl
• SGOT (AST) </= 3x upper limits of normal
• Bilirubin within institutional normal limits
• Patients must have adequate performance status (ECOG performance status 0-2.
• Patients must be age 19 or greater and have signed informed consent.

Exclusion Criteria

• Patients with history of other malignancies (except non-melanoma skin cancer or carcinoma-in-situ of the cervix) are ineligible.
• Patients with high-risk histologic subtypes of endometrial cancer, namely papillary serous or clear cell histology are ineligible.
• Patients with evidence of uterine sarcoma, including leiomyosarcoma, carcinosarcoma, endometrial stromal sarcoma, and adenosarcoma are ineligible.
• Patients who are less than 8 weeks after the completion of radiotherapy are ineligible.
• Patients receiving any other investigational agents are ineligible.
• Patients with known hypersensitivity to paclitaxel, carboplatin, or megesterol are ineligible.
• Patients with uncontrolled current illness including, but not limited to, ongoing or active infection, unstable angina pectoris, cardiac arrhythmia, serious peripheral neuropathy, or psychiatric illness/social situations that would limit or preclude compliance with study requirements are ineligible.