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

• Status: Completed
• Trial end date: 2011-10-01
• Target enrollment: 0
• Participant gender: Female

Summary

This is a study to determine the optimal treatment for patients with advanced stage or recurrent endometrial cancer. Traditionally, patients have been treated with either hormonal therapies (megesterol) or chemotherapy (paclitaxel and carboplatin). This study investigates the effectiveness of the combination of hormonal therapy and chemotherapy. This study also will examine the side-effects associated with these drugs and the quality of life of patients on combination therapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Alabama at Birmingham
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Paclitaxel

Criteria

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:

1. CT Scan

2. MRI

3. PET Scan

4. Physical Exam

• Patients must have adequate organ function defined as:

1. Platelets >/= 100,000/1

2. Granulocytes (ANC) >/= 1,500/

3. Creatinine

4. SGOT (AST)

5. 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.