Paclitaxel and Carboplatin in Women With Malignant Mixed Mullerian Tumors (MMMT) of the Uterus
Condition: Mixed Tumor, Mullerian
MeSH terms: Mixed Tumor, Mullerian; Carcinosarcoma; Mixed Tumor, Mesodermal
Intervention: Carboplatin; Paclitaxel
Intervention description: AUC 5 By Vein Over 1 Hour Every 21 Days for 6 Courses; 175 mg/m^2 By Vein Over 3 Hours Every 21 Days for 6 Courses
Intervention MeSH terms: Paclitaxel; Carboplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: Female
Healthy volunteers: No
Keywords: Uterine Neoplasms; Endometrial Cancer; Paclitaxel; Taxol; Carboplatin; Paraplatin; Malignant Mixed Mullerian Tumors; MMMT; Immunohistochemical markers

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.
    

Eligibility 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 </= 2.

          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
             </= 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.

          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.