GOG-0261

A Randomized Phase III Trial of Paclitaxel Plus Carboplatin Versus Ifosfamide Plus Paclitaxel in Chemotherapy-Naive Patients with Newly Diagnosed Stage I-IV, Persistent or Recurrent Carcinosarcoma (Mixed Mesodermal Tumors) of the Uterus, Fallopian Tube, Peritoneum or Ovary

Principal Investigator

Matthew Powell, MD

Status

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