Clinical trial NCT00502203: Paclitaxel and Carboplatin in Women With Malignant Mixed Mullerian Tumors (MMMT) of the Uterus
Official title: A Phase II Multicenter Trial of Paclitaxel and Carboplatin in Women With Advanced (IIIb, IIIc, IVa and IVb) or Recurrent (All Stages) Malignant Mixed Mullerian Tumors (MMMT) of the Uterus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Mixed Tumor, Mullerian
Keywords: Uterine Neoplasms
Endometrial Cancer
Paclitaxel
Taxol
Carboplatin
Paraplatin
Malignant Mixed Mullerian Tumors
MMMT
Immunohistochemical markers
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2007-07-17
Enrollment: 23
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: Before treatment starts, patients will have a complete check-up, blood tests, a chest x-ray, and a CT scan. Other scans or tests will be done as needed. Women able to have children must have a negative urine pregnancy test. A blood sample will be taken for routine testing once a week during treatment and a month after treatment ends.

Patients will also be asked to complete two questionnaires before they start treatment, before Courses 3 and 5, and at the end of treatment. These questionnaires will help researchers understand how this drug affects patients' daily lives and also identify the side effects caused by this treatment. Each questionnaire will take about 10 minutes to complete.

Patients in this study will be given paclitaxel and carboplatin through a catheter (tube) placed in a vein. Paclitaxel is given first (over 3 hours) followed by carboplatin (over 1 hour). All treatment is given in the outpatient department at M.D. Anderson Cancer Center.

Patients may receive up to 6 courses of treatment. If the disease gets worse or intolerable side effects occur, patients will be taken off study.

-Before each course of treatment, patients will have a checkup. At each checkup, patients will have a physical exam and blood tests. Another CT scan will be done after the third course of treatment. A complete physical exam and a CT scan will also be done at the end of treatment.

This is an investigational study. Both of the study drugs are FDA approved. Their use together in this study is experimental. A total of 50 patients will take part in this multicenter study. About 35 will be enrolled at M. D. Anderson.

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.

Primary outcomes:
measure: Number of Participants With Overall Response
timeFrame: 24 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda Cancer Institute
state: California
city: Orlando
country: United States
facility: MD Anderson Cancer Center
state: Florida
city: Houston
country: United States
facility: Lyndon Baines Johnson Hospital
state: Texas
city: Houston
country: United States
facility: UT MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: UT MD Anderson Cancer Center
name: Lois M. Ramondetta, MD
role: PRINCIPAL_INVESTIGATOR
References: