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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00584909
Recruitment Status : Terminated (low accrual)
First Posted : January 2, 2008
Results First Posted : March 29, 2012
Last Update Posted : January 27, 2017
Sponsor:
Information provided by (Responsible Party):
J. Michael Straughn, MD, University of Alabama at Birmingham

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Uterine Cancer
Intervention: Drug: Paclitaxel and carboplatin combination

  Participant Flow

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

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 
Overall Participants Analyzed 
[Units: Participants]
 13 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      8  61.5% 
>=65 years      5  38.5% 
Age 
[Units: Years]
Mean (Standard Deviation)
 63  (6) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      13 100.0% 
Male      0   0.0% 
Region of Enrollment 
[Units: Participants]
 
United States   13 


  Outcome Measures

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

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

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



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 ( Other Identifier: UAB Department study number )
First Submitted: December 21, 2007
First Posted: January 2, 2008
Results First Submitted: September 21, 2011
Results First Posted: March 29, 2012
Last Update Posted: January 27, 2017