A Phase II Study of Therapy With Paclitaxel, Carboplatin and Megesterol Acetate for the Management of Uterine Cancer
Condition: Uterine Cancer
MeSH terms: Uterine Neoplasms
Intervention: Paclitaxel ,Carboplatin , Megesterol Acetate
Intervention description: Paclitaxel will be administered at an appropriate dose (175mg/m2) as a 3 hour continuous IV infusion every 21 days. Carboplatin will be administered at an appropriate dose utilizing Calvert formula for determining the area under the curve (AUC) based on the patient's glomerular filtration rate. Megesterol Acetate will be given orally four times a day at an anti-tumor dosage of 40 mg. This will be given for a total of 6 cycles over 18 weeks with the Megace continuing for 5 years as long as no evidence of recurrence is present.
Intervention MeSH terms: Paclitaxel; Carboplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: Female
Minimum age: 19 Years
Healthy volunteers: No

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.
    

Eligibility 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 </= 1.6mg/dl

               4. SGOT (AST) </= 3x upper limits of normal

               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.