A Phase II Study of Paclitaxel and Carboplatin in Patients With an Elevated-Risk Cancer of the Uterus

This study has been terminated.
(low accrual)
Sponsor:
Information provided by (Responsible Party):
J. Michael Straughn, MD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00584909
First received: December 21, 2007
Last updated: February 28, 2012
Last verified: January 2012
Results First Received: September 21, 2011  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Uterine Cancer
Intervention: Drug: Paclitaxel and carboplatin combination

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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 Patients are administered 175 mg/m2 paclitaxel and carboplatin (dose based upon the Calvert formula for determining the area under the curve based on the patient's glomerular filtration rate). Drugs will be administered by intravenous infusion every 21 days for 6 cycles.

Participant Flow:   Overall Study
    Paclitaxel + Carboplatin  
STARTED     13  
COMPLETED     9  
NOT COMPLETED     4  
Adverse Event                 4  



  Baseline Characteristics
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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 Patients are administered 175 mg/m2 paclitaxel and carboplatin (dose based upon the Calvert formula for determining the area under the curve based on the patient's glomerular filtration rate). Drugs will be administered by intravenous infusion every 21 days for 6 cycles.

Baseline Measures
    Paclitaxel + Carboplatin  
Number of Participants  
[units: participants]
  13  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     8  
>=65 years     5  
Age  
[units: years]
Mean ± Standard Deviation
  63  ± 6  
Gender  
[units: participants]
 
Female     13  
Male     0  
Region of Enrollment  
[units: participants]
 
United States     13  



  Outcome Measures
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1.  Primary:   Disease-free Survival   [ Time Frame: 4 years - Median follow up time of 45.3 months ]

2.  Secondary:   Toxicity   [ Time Frame: 4 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
This study was terminated early due to slow accrual. 4 patients withdrew from the study due to side-effects from the treatment. All 9 patients were evaluable for toxicity and PFS.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: J. MIchael Straughn, MD
Organization: UAB
phone: 205-934-4986
e-mail: Michael.Straughn@ccc.uab.edu


No publications provided


Responsible Party: J. Michael Straughn, MD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00584909     History of Changes
Other Study ID Numbers: F060328016 (UAB 0604), UAB 0604
Study First Received: December 21, 2007
Results First Received: September 21, 2011
Last Updated: February 28, 2012
Health Authority: United States: Food and Drug Administration