Gemcitabine in Ovarian Cancer

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00191334
First received: September 12, 2005
Last updated: February 24, 2009
Last verified: February 2009
Results First Received: December 17, 2008  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Ovarian Cancer
Interventions: Drug: gemcitabine
Drug: cisplatin

  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
No text entered.

Reporting Groups
  Description
Gemcitabine + Cisplatin

Gemcitabine: 1250 mg/m2, intravenous (IV) day 1 and day 8, every 21 days x 6 cycles or disease progression or unacceptable toxicity.

Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles or disease progression or unacceptable toxicity.


Participant Flow:   Overall Study
    Gemcitabine + Cisplatin  
STARTED     50  
COMPLETED     33  
NOT COMPLETED     17  
Adverse Event                 4  
Disease Progression or Relapse                 8  
Physician Decision                 1  
Withdrawal by Subject                 4  



  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
Gemcitabine + Cisplatin

Gemcitabine: 1250 mg/m2, intravenous (IV) day 1 and day 8, every 21 days x 6 cycles or disease progression or unacceptable toxicity.

Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles or disease progression or unacceptable toxicity.


Baseline Measures
    Gemcitabine + Cisplatin  
Number of Participants  
[units: participants]
  50  
Age  
[units: years]
Mean ± Standard Deviation
  54.9  ± 10.7  
Gender  
[units: participants]
 
Female     50  
Male     0  
Region of Enrollment  
[units: participants]
 
Russian Federation     50  
Disease Stage  
[units: participants]
 
Stage I - Tumor Limited to Ovaries     0  
Stage II - Pelvic Extension and/or Implants     0  
Stage IIIa - Microscopic Peritoneal Metastasis     1  
Stage IIIb - Macroscopic Peritoneal Metastasis     3  
Stage IIIc - Peritoneal Metastasis More Than 2 cm     21  
Stage IV - Distant Metastases     25  
Eastern Cooperative Oncology Group Performance Status Score  
[units: participants]
 
0 - Fully Active     28  
1 - Ambulatory, Restricted Strenuous Activity     20  
2 - Ambulatory, No Work Activities     2  
3 - Partially Confined to Bed, Limited Self Care     0  
4 - Completely Disabled     0  
Postoperational Pathomorphological Diagnosis  
[units: participants]
 
Serous Cystadenocarcinoma     37  
Mucinosa Cystadenocarcinoma     3  
Endometrioid Carcinoma     4  
Other     6  
Race/Ethnicity  
[units: participants]
 
Caucasian     49  
Other     1  
State of Patient Relative to Menopause  
[units: participants]
 
Fertile Period     4  
Post-Menopause     46  
Time from Initial Diagnosis to Study Entry  
[units: days]
Mean ± Standard Deviation
  14.0  ± 10.3  



  Outcome Measures
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1.  Primary:   Best Overall Tumor Response   [ Time Frame: every other 21 day cycle (6-8 cycles), every 3 months during long-term follow-up ]

2.  Secondary:   Duration of Response   [ Time Frame: every other 21 day cycle (6-8 cycles) and every 3 months during long-term follow-up ]

3.  Secondary:   Time to Progressive Disease   [ Time Frame: every other 21 day cycle (6-8 cycles) and every 3 months during long-term follow-up ]

4.  Secondary:   Time to Treatment Failure   [ Time Frame: every other 21 day cycle (6-8 cycles) and every 3 months during long-term follow-up ]

5.  Secondary:   Number of Patients With Maximum Common Toxicity Criteria - National Cancer Institute (CTC-NCI): Possibly Related to Study Drug by Grade   [ Time Frame: every 21 day cycle (6-8 cycles) and every 3 months during long-term follow-up ]


  Serious Adverse Events


  Other Adverse Events


  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 Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


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.  


Results Point of Contact:  
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 1-800-545-5979


No publications provided


Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00191334     History of Changes
Other Study ID Numbers: 9340, B9E-MW-S368
Study First Received: September 12, 2005
Results First Received: December 17, 2008
Last Updated: February 24, 2009
Health Authority: Russia: Pharmacological Committee, Ministry of Health