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

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ClinicalTrials.gov Identifier: NCT00502203
Recruitment Status : Completed
First Posted : July 17, 2007
Results First Posted : January 9, 2012
Last Update Posted : May 9, 2016
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Mixed Tumor, Mullerian
Interventions Drug: Carboplatin
Drug: Paclitaxel
Enrollment 23
Recruitment Details Recruitment period: August 29, 2001 to May 08, 2009. All recruitment was done at medical clinics.
Pre-assignment Details  
Arm/Group Title Paclitaxel + Carboplatin
Hide Arm/Group Description Paclitaxel 175 mg/m^2 intravenously (IV) over 3 hours and Carboplatin AUC 5 IV over 1 hour every 21 Days for 6 courses.
Period Title: Overall Study
Started 23
Completed 22
Not Completed 1
Reason Not Completed
Inevaluable             1
Arm/Group Title Paclitaxel + Carboplatin
Hide Arm/Group Description Paclitaxel 175 mg/m^2 intravenously (IV) over 3 hours and Carboplatin AUC 5 IV over 1 hour every 21 Days for 6 courses.
Overall Number of Baseline Participants 23
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 23 participants
66
(52 to 81)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants
Female
23
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 23 participants
23
1.Primary Outcome
Title Number of Participants With Overall Response
Hide Description 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.
Time Frame 24 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Thirteen participants had measurable disease therefore evaluable for a complete or partial response.
Arm/Group Title Paclitaxel + Carboplatin
Hide Arm/Group Description:
Paclitaxel 175 mg/m^2 intravenously (IV) over 3 hours and Carboplatin AUC 5 IV over 1 hour every 21 Days for 6 courses.
Overall Number of Participants Analyzed 13
Measure Type: Number
Unit of Measure: participants
8
Time Frame 7 years and 11 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Paclitaxel + Carboplatin
Hide Arm/Group Description Paclitaxel 175 mg/m^2 intravenously (IV) over 3 hours and Carboplatin AUC 5 IV over 1 hour every 21 Days for 6 courses.
All-Cause Mortality
Paclitaxel + Carboplatin
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Paclitaxel + Carboplatin
Affected / at Risk (%)
Total   9/23 (39.13%) 
Blood and lymphatic system disorders   
Neutropenia  1  9/23 (39.13%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (2.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Paclitaxel + Carboplatin
Affected / at Risk (%)
Total   23/23 (100.00%) 
Blood and lymphatic system disorders   
Anemia  1  9/23 (39.13%) 
Neutropenia  1  11/23 (47.83%) 
Neutropenic Fever  1  3/23 (13.04%) 
Thrombocytopenia  1  1/23 (4.35%) 
Gastrointestinal disorders   
Anorexia  1  8/23 (34.78%) 
Constipation  1  5/23 (21.74%) 
Mucositis  1  1/23 (4.35%) 
Nausea  1  11/23 (47.83%) 
Vomiting  1  5/23 (21.74%) 
General disorders   
Allergic Reaction  1  2/23 (8.70%) 
Fatigue  1  21/23 (91.30%) 
Headache  1  2/23 (8.70%) 
Infections and infestations   
Infection  1  1/23 (4.35%) 
Metabolism and nutrition disorders   
Hypomagnesemia  1  1/23 (4.35%) 
Musculoskeletal and connective tissue disorders   
Myalgia  1  15/23 (65.22%) 
Nervous system disorders   
Neuropathy (sensory)  1  14/23 (60.87%) 
Neuropathy (hearing)  1  3/23 (13.04%) 
Skin and subcutaneous tissue disorders   
Alopecia  1  23/23 (100.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (2.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Lois M. Ramondetta, MD / Professor
Organization: UT MD Anderson Cancer Center
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00502203     History of Changes
Other Study ID Numbers: ID01-229
First Submitted: July 16, 2007
First Posted: July 17, 2007
Results First Submitted: December 5, 2011
Results First Posted: January 9, 2012
Last Update Posted: May 9, 2016