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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment period: August 29, 2001 to May 08, 2009. All recruitment was done at medical clinics.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Paclitaxel + Carboplatin
STARTED   23 
COMPLETED   22 
NOT COMPLETED   1 
Inevaluable                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

Baseline Measures
   Paclitaxel + Carboplatin 
Overall Participants Analyzed 
[Units: Participants]
 23 
Age 
[Units: Years]
Median (Full Range)
 66 
 (52 to 81) 
Gender 
[Units: Participants]
 
Female   23 
Male   0 
Region of Enrollment 
[Units: Participants]
 
United States   23 


  Outcome Measures

1.  Primary:   Number of Participants With Overall Response   [ Time Frame: 24 Months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

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
e-mail: CR_Study_Registration@mdanderson.org



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