Clinical Trial: Radiation Therapy, Paclitaxel, and Carboplatin in Treating Patients With Uterine Cancer

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: A Pilot Trial of Radiation Therapy "Sandwiched" Between Paclitaxel and Carboplatin in Patients With Uterine Carcinosarcoma

Brief Summary: This pilot clinical trial studies radiation therapy, paclitaxel, and carboplatin in treating patients with uterine cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or stopping them from dividing. Giving radiation with chemotherapy may kill more tumor cells.

Detailed Summary:

PRIMARY OBJECTIVES:

I. To assess the one year recurrence-free survival in patients with uterine carcinosarcoma treated with "sandwich" therapy-including defining the patterns of recurrence in patients with carcinosarcoma who were treated with this regimen.

II. To evaluate the toxicity and tolerability of pelvic radiation "sandwiched" between cycles of paclitaxel/carboplatin chemotherapy in patients with uterine carcinosarcoma.

III. To correlate surrogate endpoint biomarkers with progression-free survival and prognosis.

OUTLINE:

CHEMOTHERAPY (weeks 1-9, 14-22): Patients receive paclitaxel intravenously (IV) over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 3 courses during weeks 1-9 and 14-22.

RADIATION THERAPY (weeks 8-16): Patients undergo external beam pelvic radiation therapy once a day, 5 days a week for 5 weeks during weeks 8-13. Patients then undergo high dose radiation (HDR) brachytherapy or intensity-modulated radiation therapy (IMRT) once weekly during weeks 14-16.

After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.


Sponsor: Albert Einstein College of Medicine, Inc.

Current Primary Outcome: Recurrence-free survival [ Time Frame: Date of entry to date of reappearance of disease, assessed at 1 year ]

One-year recurrence-free survival probability will be estimated, with 95% confidence limits based on exact methods for the binomial distribution.


Original Primary Outcome: Recurrence-free survival [ Time Frame: 2 years ]

Recurrence-free survival is defined as date of entry to date of reappearance of disease. Site(s) and date of relapse will be recorded. Recurrent disease will be defined as pelvic or distant. Pelvic sites will be specified as vaginal or other, and distant sites will be specified as to their anatomic location. Relapse should be confirmed by histologic or cytologic evaluation when possible.


Current Secondary Outcome:

Original Secondary Outcome: Toxicity [ Time Frame: 2 years ]

Toxicities will be graded according to the NCI Common Toxicity Criteria (version 4). Myelosuppressive toxicity will be reported as the lowest observed white blood and platelet counts. Anemia and red blood cell transfusions will be noted. Gastrointestinal toxicities will be reported and hospitalizations for nausea,vomiting and diarrhea will be documented. Patients will be followed for potential long-term toxicities with complete histories and physical examinations. Any patient who receives at least one course of therapy and has follow-up information will be included for observation of toxicity.


Information By: Albert Einstein College of Medicine, Inc.

Dates:
Date Received: June 3, 2011
Date Started: May 2011
Date Completion:
Last Updated: January 16, 2015
Last Verified: January 2015