Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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: October 4, 2016
Last verified: October 2016
Results First Received: October 4, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Ovarian Cancer
Intervention: Drug: Paclitaxel

  Participant Flow
  Hide 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: July 2003 - December 2004

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 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
  Hide 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 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]
 
Female   105 
Male   0 
Region of Enrollment 
[Units: Participants]
 
Germany   105 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Progression-free Survival   [ Time Frame: every 3 months ]

2.  Secondary:   Toxicity   [ Time Frame: after every cycle ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
No text entered.


  More Information
  Hide 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: 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: October 4, 2016
Health Authority: Germany: Federal Institute for Drugs and Medical Devices