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
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
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
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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Participants With Overall Response
Overall response rate including complete (CR) and partial responses (PR) with measurable disease using Response Evaluation Criteria In Solid Tumors (RECIST) assessment. CR: Disappearance of all target and non-target lesions; no evidence of new lesions documented by 2 disease assessments at least 4 weeks apart. PR: At least 30% decrease in sum of longest dimensions (LD) of all target measurable lesions reference baseline sum of LD; no unequivocal progression of non-target lesions and no new lesions. Documentation by 2 disease assessments at least 4 weeks apart is required.
Lois M. Ramondetta, MD
UT MD Anderson Cancer Center
United States: Institutional Review Board
|UT MD Anderson Cancer Center||Houston, Texas 77030|
|MD Anderson Cancer Center||Orlando, Florida 32806|
|Lyndon Baines Johnson Hospital||Houston, Texas 77026|
|Loma Linda Cancer Institute||Loma Linda, California 92354|