University of Southern California
USC Norris Comprehensive Cancer Center
If you are a patient, please contact Keck Medical Center of USC at 800-USC-CARE.

Trial GOG-0261


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.

Type: Cancer Therapy
Phase: Phase III
Status: Not Open (Closed)
Treatments: Chemotherapy: Systemic
Randomized: Yes
Defintions of terms and FAQ about clinical trials.
Trial Leaders/Researchers:  Huyen Q. Pham, M.D.
Other Trial Staff:  Kristy Watkins, R.N., Grace Facio, R.N., Marissa Aldana, D.M., Yvonne Flores, D.M.

Staff may log in to see study documents.


You may participate in this study if:
 Requirement
1Newly diagnosed stage I-IV, persistent or recurrent (including unstaged) uterine or ovarian carcinosarcoma (malignant mixed mullerian tumor - MMMT) and be chemotherapy naïve as directed against uterine or ovarian carcinosarcoma. Review of the pathologic specimen from the uterus or ovary is required. Unstaged patients (patients who have not had hysterectomy or ovarian surgery) are eligible and should be included as “unstaged” if the only histologic (pathology) documentation of the disease is a biopsy or curettage of the uterus. If these patients have documented metastatic disease, it should be assigned the appropriate Stage (III/IV).
2May have received prior adjuvant external beam RT and/or vaginal brachytherapy. Patients should be at least 4 weeks from the completion of external beam RT prior to beginning protocol chemotherapy. Patients do not need to be delayed if receiving vaginal brachytherapy only.
3Measurable disease or non-measurable disease
4At least 18 years of age
5GOG performance status of 0, 1, or 2
6Must have recovered from effects of recent surgery, RT, or other therapy
7Free of active infection requiring antibiotics
8Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to beginning protocol chemotherapy. Continuation of hormone replacement therapy is permitted.
9AGC = / > 1.5; platelets = / > 100,000
10Bilirubin < / = 1.5 x uln; SGOT and alk phos < / = 2.5 x uln; albumin = / > 3 gm/dl
11Creatinine < / = 1.5 x uln
12Neuropathy (sensory and motor) < / = Gr 1
13Patients of childbearing potential must have a negative serum pregnancy test prior to study entry and be practicing an effective form of contraception
14Signed an approved study-specific informed consent and HIPAA


You may not participate in this study if:
1Prior cytotoxic chemotherapy for management of uterine or ovarian carcinosarcoma
2History of other invasive malignancies or with a concomitant invasive malignancy, except non-melanoma skin cancer, if there is any evidence of other malignancy being present within the last five years. Patients are also ineligible if their previous cancer treatment contraindicates this protocol therapy
3RT is planned after or during study chemotherapy prior to progression of cancer
4Known hypersensitivity to E. coli-derived drug preparations (Pegfilgrastim and Filgrastim)
5Known hypersensitivity to mesna or other thiol compounds
6Not biopsy proven to have carcinosarcoma of the uterus or ovary



For further information on a study, please contact the Clinical Investigation Support Office at (323) 865-0451, or clinical.trials@med.usc.edu.

To schedule a consultation with the hospital, please call our New Patient Referrals Office at (323) 865-3111.