Paclitaxel and Carboplatin in Women With Malignant Mixed Mullerian Tumors (MMMT) of the Uterus
|ClinicalTrials.gov Identifier: NCT00502203|
Recruitment Status : Completed
First Posted : July 17, 2007
Results First Posted : January 9, 2012
Last Update Posted : May 9, 2016
|Condition or disease||Intervention/treatment||Phase|
|Mixed Tumor, Mullerian||Drug: Carboplatin Drug: Paclitaxel||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||August 2001|
|Actual Primary Completion Date :||November 2010|
|Actual Study Completion Date :||November 2010|
Experimental: Paclitaxel + Carboplatin
Paclitaxel 175 mg/m^2 intravenously (IV) over 3 hours and Carboplatin AUC 5 IV over 1 hour every 21 Days for 6 courses.
AUC 5 By Vein Over 1 Hour Every 21 Days for 6 Courses
Other Name: Paraplatin
175 mg/m^2 By Vein Over 3 Hours Every 21 Days for 6 Courses
Other Name: Taxol
- Number of Participants With Overall Response [ Time Frame: 24 Months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00502203
|United States, California|
|Loma Linda Cancer Institute|
|Loma Linda, California, United States, 92354|
|United States, Florida|
|MD Anderson Cancer Center|
|Orlando, Florida, United States, 32806|
|United States, Texas|
|Lyndon Baines Johnson Hospital|
|Houston, Texas, United States, 77030|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Lois M. Ramondetta, MD||UT MD Anderson Cancer Center|