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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
History of Changes

March 5, 2008
April 2, 2008
November 2002
Not Provided
Overall response rate [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
  • Duration of overall response [ Time Frame: Weeks 6, 12, 18, 24, 36, and 1 year ] [ Designated as safety issue: No ]
  • Overall tumour growth control rate [ Time Frame: Weeks 6, 12, 18, 24, 36, and 1 year ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Weeks 6, 12, 18, 24, 36, and 1 year ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: Weeks 6, 12, 18, 24, 36, and 1 year ] [ Designated as safety issue: Yes ]
  • Physical exam [ Time Frame: Weeks 6, 12, 18, 24, 36, and 1 year ] [ Designated as safety issue: Yes ]
  • Laboratory tests [ Time Frame: Weeks 6, 12, 18, 24, 36, and 1 year ] [ Designated as safety issue: Yes ]
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
Endpoint Classification: Safety/Efficacy Study
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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
China,   Hong Kong,   Korea, Republic of,   Taiwan
 
NCT00635323
XRP4174/2501, A5961080
No
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