A Phase II Study of Paclitaxel and Carboplatin in Patients With an Elevated-Risk Cancer of the Uterus

• Status: Terminated
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

The main purpose of this study us to determine the best treatment for patients with endometrial cancer who are at an elevated risk for recurrence.

• 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 a elevated risk, surgical stage II, stage IC, grade 2 or 3 adenocarcinoma of the endometrium.

• Patients must have undergone, a total abdominal hysterectomy, bilateral salpingo-oophorectomy, peritoneal washings, and a pelvic and para-aortic lymphadenectomy.

• Patients must have adequate organ function defined as:

1. Platelets >/= 100,000/µ

2. Granulocytes (ANC)>/= 1,500/µl

3. Creatinine

4. SGOT (AST)

5. Bilirubin within institutional normal limits

• Patients must have adequate performance status (ECOG performance status 0-2 or Karnofsky Performance Status >40)

• Patients must be age 19 or greater and have signed informed consent.

Exclusion Criteria:

• Patients with history of other malignancies within 5 years (except non- melanoma skin cancer or carcinoma-in-situ of the cervix) are ineligible.

• Patients with high-risk histologic subtypes of endometrial cancer such as papillary serous or clear cell histology are ineligible.

• Patients with histologic evidence of uterine sarcoma, including leiomyosarcoma, carcinosarcoma, endometrial stromal sarcoma, and adenosarcoma are ineligible.

• Patients who have received past pelvic radiotherapy are ineligible.

• Patients receiving any other investigational agents are ineligible.

• Patients with known hypersensitivity to paclitaxel and/or carboplatin are ineligible.