Therapy With Topotecan and Carboplatin by Patients With Relapsed Ovarian Cancer

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. Identifier: NCT00170625
Recruitment Status : Completed
First Posted : September 15, 2005
Results First Posted : February 6, 2017
Last Update Posted : February 6, 2017
Information provided by (Responsible Party):
North Eastern Germany Society of Gynaecologic Oncology

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Ovarian Cancer
Intervention: Drug: Hycamtin

  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: 2.6.2004 – 30.8.2005

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
2 patients missed the inclusion criteria

Reporting Groups
Hycamtin Topotecan 1mg/m2/d on day 1-3, q 21 Carboplatin AUC 5 on day 3, q 21

Participant Flow:   Overall Study

  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
Hycamtin Topotecan 1mg/m2/d on day 1-3, q 21d

Baseline Measures
Overall Participants Analyzed 
[Units: Participants]
[Units: Years]
Median (Full Range)
 (28 to 75) 
[Units: Participants]
Count of Participants
Female      26 100.0% 
Male      0   0.0% 
Region of Enrollment 
[Units: Participants]
Germany   26 

  Outcome Measures

1.  Primary:   Toxicity   [ Time Frame: after each cycle for up to one year ]

2.  Secondary:   Progression-free Survival   [ Time Frame: after every third cycle, for up to one year ]

  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
No text entered.

  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI 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

Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: North Eastern Germany Society of Gynaecologic Oncology Identifier: NCT00170625     History of Changes
Other Study ID Numbers: 310300
First Submitted: September 9, 2005
First Posted: September 15, 2005
Results First Submitted: October 4, 2016
Results First Posted: February 6, 2017
Last Update Posted: February 6, 2017