Paclitaxel and Carboplatin in Women With Malignant Mixed Mullerian Tumors (MMMT) of the Uterus

Completed · Phase 2

Conditions studied: Mixed Tumor, Mullerian

In brief

The goal of this clinical research study is to find out if the combination of paclitaxel and carboplatin chemotherapy can shrink or slow the growth of mixed mullerian tumors (MMMT) of the uterus.

Key facts

Study ID

NCT00502203

Run by

M.D. Anderson Cancer Center

People needed

23

Starts

2001-08-01

Expected to finish

2010-11-01

Last updated by the study team

2016-05-09

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Patients with histologically confirmed advanced (IIIb, IIIc, IVa and IVb) or recurrent (all stages) MMMT.
• Prior chemotherapy is permitted with the exception of patients previously treated with platinum and/or taxol chemotherapy for this disease.
• Women of any racial and ethnic group.
• Eastern Cooperative Oncology Group (ECOG) performance status </= 2.
• Expected survival of >/= 12 weeks.
• Patients must have recovered from the side effects of prior therapy (chemotherapy, surgery, or radiation) before entering the study.
• Adequate liver, renal, and bone marrow function, defined as: a total bilirubin value </= 1.5 mg/dL; serum glutamic pyruvic transaminase (SGPT) </= 2 times upper limit of normal or </= 5 times upper limit of normal when liver metastases are present; serum creatinine </= 1.5 mg/dL; Absolute neutrophil count (ANC) >/= 1,500/ul; platelet count >/= 100,000/ul. All qualifying laboratory parameters must be determined within 1 week prior to first treatment.
• Participants must agree to practice approved methods of birth control (if applicable).
• Patients must sign an institutionally approved informed consent.

You may not qualify if…

• Patients with a Zubrod performance status of 3 or greater.
• Concurrent cancer chemotherapy, radiotherapy or surgery.
• History of other malignancy (except nonmelanoma skin cancer or carcinoma in situ of the cervix), unless in complete remission and off all therapy for that disease for a minimum of 5 years.
• Presence of known untreated brain metastases.
• Overt psychosis or mental disability or otherwise incompetent to give informed consent.
• Patients with an active systemic infection.
• Patients with a serious intercurrent medical illness.
• Patients with a history of neuropsychiatric or seizure disorders.

Where it is running

• Loma Linda Cancer Institute — Loma Linda, California, United States
• MD Anderson Cancer Center — Orlando, Florida, United States
• Lyndon Baines Johnson Hospital — Houston, Texas, United States
• UT MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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