Second-Line Therapy Study For Potentially Platinum-Sensitive Relapsed Ovarian Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00316173
First received: April 19, 2006
Last updated: November 21, 2012
Last verified: November 2012
Results First Received: October 20, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Ovarian Cancer
Neoplasms, Ovarian
Interventions: Drug: topotecan
Drug: CARBOPLATIN

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The run-in phase was conducted to find a safe dose of drug, before the treatment phase of the study began. Different doses were given to 22 participants (enrolled a few at a time) to find the safest dose. Once the safe dose was found, 55 new participants were enrolled in the treatment phase, and all were to start their treatment at this safe dose.

Reporting Groups
  Description
Dose-finding Phase Starting dose of 2.0 milligrams (mg)/square meter (m2) topotecan (Days 1 and 8, every 21 days) and area under the curve (AUC) 5 carboplatin (Day 1 every 21 days)
Activity Assessment Phase Topotecan 2.5 mg/m2 (starting dose determined from the dose-finding phase) administered as a 30 minute intravenous (IV) infusion on Days 1 and 8, every 21 days. Carboplatin AUC 5 administered as a 30 minute IV infusion on Day 1, every 21 days.

Participant Flow for 2 periods

Period 1:   Run-in Phase
    Dose-finding Phase     Activity Assessment Phase  
STARTED     22     0  
COMPLETED     15     0  
NOT COMPLETED     7     0  
Adverse Event                 1                 0  
Protocol Violation                 1                 0  
Study Follow-up Stopped                 5                 0  

Period 2:   Treatment Phase
    Dose-finding Phase     Activity Assessment Phase  
STARTED     0     55  
COMPLETED     0     13  
NOT COMPLETED     0     42  
Adverse Event                 0                 1  
Lack of Efficacy                 0                 3  
Lost to Follow-up                 0                 3  
Withdrawal by Subject                 0                 1  
Study Follow-up Stopped                 0                 34  



  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.
No text entered.

Reporting Groups
  Description
Dose-finding Phase Starting dose of 2.0 milligrams (mg)/square meter (m2) topotecan (Days 1 and 8, every 21 days) and area under the curve (AUC) 5 carboplatin (Day 1 every 21 days)
Activity Assessment Phase Topotecan 2.5 mg/m2 (starting dose determined from the dose-finding phase) administered as a 30 minute intravenous (IV) infusion on Days 1 and 8, every 21 days. Carboplatin AUC 5 administered as a 30 minute IV infusion on Day 1, every 21 days.
Total Total of all reporting groups

Baseline Measures
    Dose-finding Phase     Activity Assessment Phase     Total  
Number of Participants  
[units: participants]
  22     55     77  
Age  
[units: years]
Mean ± Standard Deviation
  63.8  ± 10.94     62.2  ± 11.13     62.6  ± 11.03  
Gender  
[units: participants]
     
Female     22     55     77  
Male     0     0     0  
Race/Ethnicity, Customized  
[units: participants]
     
African American/African Heritage     2     2     4  
American Indian or Alaska Native     0     1     1  
Asian     1     3     4  
White     19     48     67  
Missing     0     1     1  
Number of participants with the indicated ECOG Performance Status [1]
[units: participants]
     
Grade 0     15     42     57  
Grade 1     7     9     16  
Grade 2     0     4     4  
[1] Eastern Cooperative Oncology Group (ECOG) performance status assesses the effect of disease on daily living abilities, graded as: Grade 0: fully active, able to carry on all pre-disease performance without restriction; Grade 1: Restricted in physically strenuous activity; Grade 2: Capable of all selfcare, but unable to carry out any work activities.



  Outcome Measures
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1.  Primary:   Number of Participants With the Indicated Response   [ Time Frame: From start of treatment to evidence of CR or PR (up to 39.3 weeks). ]

2.  Secondary:   Time to Response   [ Time Frame: From start of treatment to evidence of PR or CR (up to 39.3 weeks) ]

3.  Secondary:   Duration of Response   [ Time Frame: From time of PR or CR to disease progression/death (up to 56.0 weeks) ]

4.  Secondary:   Progression-free Survival   [ Time Frame: From start of treatment to disease progression/death (up to 67.7 weeks) ]

5.  Secondary:   Number of Participants Who Died From the Start of Treatment to Follow-up   [ Time Frame: From start of treatment to death (up to 110.4 weeks). ]

6.  Secondary:   The Number of Participants Classified as Responders in Cancer Antigen 125 (CA-125)   [ Time Frame: Baseline to end of study (up to 54.7 weeks). ]

7.  Secondary:   Time to Disease Progression   [ Time Frame: From start of treatment to disease progression/death ]


  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
As only 17 of 55 participants had CR/PR, the treatment was not effective. The follow up of participants for survival was thus stopped early (original plan: every 3 months for 2 years; then every 6 months for 3-5 years; then annually/until death).


  More Information
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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 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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


Publications:
Schwartz PE, Rose PG, Monk BJ, et al. An open-label, single arm, phase II study of IV weekly (days 1 and 8) topotecan in combination with carboplatin (day 1) every 21 days as second-line therapy in subjects with platinum sensitive relapsed ovarian cancer: First stage results. J Clin Oncol. 2008; 26 (May 20 suppl). Abstract 16518


Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00316173     History of Changes
Other Study ID Numbers: 104864/902
Study First Received: April 19, 2006
Results First Received: October 20, 2009
Last Updated: November 21, 2012
Health Authority: Canada: Canadian Institutes of Health Research
United States: Food and Drug Administration