Topotecan in Treating Patients With Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00114166
First received: June 13, 2005
Last updated: May 27, 2014
Last verified: May 2014
Results First Received: May 27, 2014  
Study Type: Interventional
Study Design: Masking: Open Label;   Primary Purpose: Treatment
Conditions: Fallopian Tube Cancer
Ovarian Cancer
Primary Peritoneal Cavity Cancer
Intervention: Drug: topotecan hydrochloride

  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
Study amended 12/11/06 to discontinue Regimen I for lack of interest by institutions.

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
Topotecan Includes both Regimen I Topotecan 1.25 mg/m2 IV days 1-5 of a 21-day cycle until disease progression or adverse effects prohibit further therapy and Regimen II Topotecan 4.0 mg/m2 IV day 1, 8 and 15 of a 28-day cycle until disease progression or adverse effects prohibit further therapy

Participant Flow:   Overall Study
    Topotecan  
STARTED     81 [1]
Registered to Regimen I     15  
Registered to Regimen II     65  
COMPLETED     80 [2]
NOT COMPLETED     1  
Wrong primary                 1  
[1] total number of participants enrolled
[2] total numbers of eligible and evaluable participants



  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.
Total number eligible and evaluable participants from Regimen I and Regimen II

Reporting Groups
  Description
Topotecan Includes both Regimen I Topotecan 1.25 mg/m2 IV days 1-5 of a 21-day cycle until disease progression or adverse effects prohibit further therapy and Regimen II Topotecan 4.0 mg/m2 IV day 1, 8 and 15 of a 28-day cycle until disease progression or adverse effects prohibit further therapy

Baseline Measures
    Topotecan  
Number of Participants  
[units: participants]
  80  
Age, Customized  
[units: years]
Mean ± Standard Deviation
  61.7  ± 9.4  
Age, Customized  
[units: participants]
 
40-49 years     7  
50-59 years     32  
60-69 years     21  
70-79 years     17  
80-89 years     3  
Gender  
[units: participants]
 
Female     80  
Male     0  
Region of Enrollment  
[units: participants]
 
United States     80  
Cell Type  
[units: participants]
 
Adenocarcinoma, Unspecified     5  
Clear Cell Carcinoma     2  
Endometrioid Adenocarcinoma     2  
Mixed Epithelial Carcinoma     6  
Undifferentiated Carcinoma     1  
Serous Adenocarcinoma     63  
Other Carcinoma     1  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Objective Tumor Response   [ Time Frame: Every other cycle for the first 6 months, then every 3 months x2, then every 6 months until disease progression or study withdrawal ]

2.  Secondary:   Reason Off Study Therapy   [ Time Frame: study entry through end of study treatment ]

3.  Primary:   Frequency and Severity of Observed Adverse Effects   [ Time Frame: Study entry through disease progression or study withdrawal ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes


  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: Jessalyn Reboy
Organization: NRG Oncology, Statistics and Data Management Center - Buffalo Office
phone: 716-845-7738
e-mail: ReboyJ@nrgoncology.org


Publications of Results:

Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00114166     History of Changes
Other Study ID Numbers: GOG-0146Q, GOG-0146Q, CDR0000434848
Study First Received: June 13, 2005
Results First Received: May 27, 2014
Last Updated: May 27, 2014
Health Authority: United States: Federal Government