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Trial record 1 of 1 for:    NCT00635323
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Safety And Efficacy Of Irinotecan Plus Capecitabine As First-Line Treatment In Asian Subjects With Hepatocellular Carcinoma

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.
 
ClinicalTrials.gov Identifier: NCT00635323
Recruitment Status : Completed
First Posted : March 13, 2008
Last Update Posted : April 7, 2008
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE March 5, 2008
First Posted Date  ICMJE March 13, 2008
Last Update Posted Date April 7, 2008
Study Start Date  ICMJE November 2002
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: March 5, 2008)
Overall response rate [ Time Frame: Week 6 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 5, 2008)
  • Time to progression [ Time Frame: Weeks 6, 12, 18, 24, 36, and 1 year ]
  • Duration of overall response [ Time Frame: Weeks 6, 12, 18, 24, 36, and 1 year ]
  • Overall tumour growth control rate [ Time Frame: Weeks 6, 12, 18, 24, 36, and 1 year ]
  • Overall survival [ Time Frame: Weeks 6, 12, 18, 24, 36, and 1 year ]
  • Adverse events [ Time Frame: Weeks 6, 12, 18, 24, 36, and 1 year ]
  • Physical exam [ Time Frame: Weeks 6, 12, 18, 24, 36, and 1 year ]
  • Laboratory tests [ Time Frame: Weeks 6, 12, 18, 24, 36, and 1 year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety And Efficacy Of Irinotecan Plus Capecitabine As First-Line Treatment In Asian Subjects With Hepatocellular Carcinoma
Official Title  ICMJE A Phase 2 Study of the Efficacy and Safety of Irinotecan (Campto®) in Combination With Capecitabine (Xeloda®) as First-Line Chemotherapy in Asian Subjects With Inoperable Hepatocellular Carcinoma
Brief Summary To evaluate the safety and efficacy of irinotecan and capecitabine in Asian subjects with inoperable hepatocellular carcinoma.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Carcinoma, Hepatocellular
Intervention  ICMJE Drug: Irinotecan plus capecitabine
Irinotecan 200-250 mg/m2 intravenous infusion over 30 to 90 minutes on day 1 of a 3-week cycle. Capecitabine 1000 mg/m2 oral tablet twice daily for 14 days followed by a 7 day rest throughout the treatment period for
Study Arms  ICMJE Experimental: A
Intervention: Drug: Irinotecan plus capecitabine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: March 5, 2008)
73
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Asian subjects with histologically or cytologically confirmed hepatocellular carcinoma
  • Inoperable disease (unable to completely remove surgically, presence of extra-hepatic disease, main portal vein or hepatic vein involvement)
  • Eastern Cooperative Oncology Group performance status of ?2

Exclusion Criteria:

  • Decompensated cirrhosis or stage C (Index>10) according to the Child-Pugh Classification
  • Current history of chronic diarrhoea
  • Reproductive potential not using adequate contraceptive measures
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China,   Hong Kong,   Korea, Republic of,   Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00635323
Other Study ID Numbers  ICMJE XRP4174/2501
A5961080
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP