A Randomized Phase III Trial of Paclitaxel Plus Carboplatin Versus Ifosfamide Plus Paclitaxel in Chemotherapy-Naïve Patients with Newly Diagnosed Stage I-IV, Persistent or Recurrent Carcinosarcoma (Mixed Mesodermal Tumors) of the Uterus or Ovary
Principal Investigator
Matthew Powell, MD
Status
Terminated
Date Opened To Accrual
August 17 2009
Date Closed to Accrual
March 24 2014
Date of Study Termination
May 24 2022
Disease Site
Gynecologic [GY]
Uterine Corpus
Phase
III
Developmental Therapeutics
No
Primary Objective
To determine if treatment with combination paclitaxel and carboplatin (TC) chemotherapy does not result in an inferior death rate when compared to ifosfamide, mesna, and paclitaxel chemotherapy.
Patient Population
Patients must have newly diagnosed Stage I-IV, persistent or recurrent (including unstaged) uterine carcinosarcoma (malignant mixed mullerian tumor-MMMT or with ovarian, fallopian tube or peritoneal carcinosarcoma and an enrollment date prior to 10/21/2013) and be chemotherapy naïve as directed against their carcinosarcoma.
Target Accrual
603
Patient Study Webpage
There is no available patient study webpage available for this trial at this time.