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Safety And Efficacy Of Irinotecan Plus Capecitabine As First-Line Treatment In Asian Subjects With Hepatocellular Carcinoma

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00635323
First received: March 5, 2008
Last updated: April 2, 2008
Last verified: April 2008

March 5, 2008
April 2, 2008
November 2002
Not Provided
Overall response rate [ Time Frame: Week 6 ]
Same as current
Complete list of historical versions of study NCT00635323 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Safety And Efficacy Of Irinotecan Plus Capecitabine As First-Line Treatment In Asian Subjects With Hepatocellular Carcinoma
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
To evaluate the safety and efficacy of irinotecan and capecitabine in Asian subjects with inoperable hepatocellular carcinoma.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Carcinoma, Hepatocellular
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
Experimental: A
Intervention: Drug: Irinotecan plus capecitabine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
73
May 2005
Not Provided

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
China,   Hong Kong,   Korea, Republic of,   Taiwan
 
 
NCT00635323
XRP4174/2501, A5961080
No
Not Provided
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2008

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