Overview

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

Status:
Completed
Trial end date:
2010-11-01
Target enrollment:
0
Participant gender:
Female
Summary
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Treatments:
Albumin-Bound Paclitaxel
Carboplatin
Paclitaxel
Criteria
Inclusion Criteria:

1. Patients with histologically confirmed advanced (IIIb, IIIc, IVa and IVb) or recurrent
(all stages) MMMT.

2. Prior chemotherapy is permitted with the exception of patients previously treated with
platinum and/or taxol chemotherapy for this disease.

3. Women of any racial and ethnic group.

4. Eastern Cooperative Oncology Group (ECOG) performance status
5. Expected survival of >/= 12 weeks.

6. Patients must have recovered from the side effects of prior therapy (chemotherapy,
surgery, or radiation) before entering the study.

7. Adequate liver, renal, and bone marrow function, defined as: a total bilirubin value
normal or creatinine /= 1,500/ul; platelet count
>/= 100,000/ul. All qualifying laboratory parameters must be determined within 1 week
prior to first treatment.

8. Participants must agree to practice approved methods of birth control (if applicable).

9. Patients must sign an institutionally approved informed consent.

Exclusion Criteria:

1. Patients with a Zubrod performance status of 3 or greater.

2. Concurrent cancer chemotherapy, radiotherapy or surgery.

3. 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.

4. Presence of known untreated brain metastases.

5. Overt psychosis or mental disability or otherwise incompetent to give informed
consent.

6. Patients with an active systemic infection.

7. Patients with a serious intercurrent medical illness.

8. Patients with a history of neuropsychiatric or seizure disorders.