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: Closed to Accrual with Ongoing Follow-up
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.

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You may participate in this study if:

	Requirement
1	Newly 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).
2	May 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.
3	Measurable disease or non-measurable disease
4	At least 18 years of age
5	GOG performance status of 0, 1, or 2
6	Must have recovered from effects of recent surgery, RT, or other therapy
7	Free of active infection requiring antibiotics
8	Any 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.
9	AGC = / > 1.5; platelets = / > 100,000
10	Bilirubin < / = 1.5 x uln; SGOT and alk phos < / = 2.5 x uln; albumin = / > 3 gm/dl
11	Creatinine < / = 1.5 x uln
12	Neuropathy (sensory and motor) < / = Gr 1
13	Patients of childbearing potential must have a negative serum pregnancy test prior to study entry and be practicing an effective form of contraception
14	Signed an approved study-specific informed consent and HIPAA

You may not participate in this study if:

1	Prior cytotoxic chemotherapy for management of uterine or ovarian carcinosarcoma
2	History 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
3	RT is planned after or during study chemotherapy prior to progression of cancer
4	Known hypersensitivity to E. coli-derived drug preparations (Pegfilgrastim and Filgrastim)
5	Known hypersensitivity to mesna or other thiol compounds
6	Not 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.