Irinotecan Study For Cervical Cancer

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00136955
First received: August 25, 2005
Last updated: August 26, 2009
Last verified: July 2009
Results First Received: May 7, 2009  
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: Uterine Cervical Neoplasms
Intervention: Drug: Irinotecan

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All 41 subjects had a primary diagnosis of squamous cell carcinoma of the cervix with a mean duration of 2.8 years (range: 0-12.9 years) since first diagnosis. No subject had a history of other cancer.

Reporting Groups
  Description
Irinotecan/Cisplatin Intravenous irinotecan (60 milligrams [mg]/metered square [m2]) on days 1, 8, and 15 plus cisplatin (60mg/m2) on day 1. Treatment cycle was repeated every 4 weeks.

Participant Flow:   Overall Study
    Irinotecan/Cisplatin  
STARTED     41  
COMPLETED     18  
NOT COMPLETED     23  
Adverse Event                 8  
Lost to Follow-up                 1  
Withdrawal by Subject                 2  
Incl. prog. disease, protocol violation                 12  



  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
Irinotecan/Cisplatin Intravenous irinotecan (60 milligrams [mg]/metered square [m2]) on days 1, 8, and 15 plus cisplatin (60mg/m2) on day 1. Treatment cycle was repeated every 4 weeks.

Baseline Measures
    Irinotecan/Cisplatin  
Number of Participants  
[units: participants]
  41  
Age  
[units: years]
Mean ± Standard Deviation
  55.9  ± 9.6  
Gender  
[units: participants]
 
Female     41  
Male     0  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Response to Treatment Based on Response Evaluation Criteria in Solid Tumors (RECIST) Criteria (Evaluable Population)   [ Time Frame: At baseline and every 8 weeks through end of treatment (21-28 days after last administration of study treatment) ]

2.  Primary:   Response to Treatment Based on RECIST Criteria (Intent-to-Treat [ITT] Population)   [ Time Frame: At baseline and every 8 weeks through end of treatment (21-28 days after last administration of study treatment) ]

3.  Secondary:   Overall Survival (OS) and Time to Tumor Progression (TTP) (Evaluable Population)   [ Time Frame: Tumor response measurements were made at baseline, according to RECIST criteria. After end of treatment, subject was followed-up every 12 weeks plus or minus 2 weeks. ]

4.  Secondary:   Overall Survival (OS) and Time to Tumor Progression (ITT Population)   [ Time Frame: Tumor response measurements were made at baseline, according to RECIST criteria. After end of treatment, subject was followed-up every 12 weeks plus or minus 2 weeks. ]


  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 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: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.govCallCenter@pfizer.com


No publications provided


Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00136955     History of Changes
Other Study ID Numbers: XRP4174/2502, A5961083
Study First Received: August 25, 2005
Results First Received: May 7, 2009
Last Updated: August 26, 2009
Health Authority: Taiwan: Department of Health