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Taxol Carboplatin and Erythropoetin

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
North Eastern Germany Society of Gynaecologic Oncology
ClinicalTrials.gov Identifier:
NCT00158379
First received: September 9, 2005
Last updated: December 12, 2016
Last verified: December 2016
Results First Received: October 4, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Ovarian Cancer
Intervention: Drug: Paclitaxel

  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
recruitment period: July 2003 - December 2004

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Paclitaxel Paclitaxel: 4 cycles of Carboplatin AUC 5 every 3 weeks. 12 weekly infusions of 80 mg/m² Taxol®

Participant Flow:   Overall Study
    Paclitaxel
STARTED   105 
COMPLETED   105 
NOT COMPLETED   0 



  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.
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Reporting Groups
  Description
Paclitaxel Paclitaxel: 4 cycles of Carboplatin AUC 5 every 3 weeks. 12 weekly infusions of 80 mg/m² Taxol®

Baseline Measures
   Paclitaxel 
Overall Participants Analyzed 
[Units: Participants]
 105 
Age 
[Units: Years]
Median (Full Range)
 60.4 
 (23.4 to 80.3) 
Gender 
[Units: Participants]
Count of Participants
 
Female      105 100.0% 
Male      0   0.0% 
Region of Enrollment 
[Units: Participants]
 
Germany   105 


  Outcome Measures
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1.  Primary:   Progression-free Survival. Progression is Defined According WHO-criteria as Appearance of Any New Lesion or Increase of Existing Lesions by at Least 25%   [ Time Frame: every 3 months for up to 3 years ]

2.  Secondary:   Toxicity   [ Time Frame: after every cycle during therapy phase and after every 3 months during follow-up, for up to 3 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
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  More Information
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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: Prof. Dr. Jalid Sehouli
Organization: Charite Campus Vichow Klinikum
phone: +49 30-450564052
e-mail: jalid.sehouli@charite.de



Responsible Party: North Eastern Germany Society of Gynaecologic Oncology
ClinicalTrials.gov Identifier: NCT00158379     History of Changes
Other Study ID Numbers: 3002000
Study First Received: September 9, 2005
Results First Received: October 4, 2016
Last Updated: December 12, 2016