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
  Purpose

To evaluate the safety and efficacy of irinotecan and capecitabine in Asian subjects with inoperable hepatocellular carcinoma.


Condition Intervention Phase
Carcinoma, Hepatocellular
Drug: Irinotecan plus capecitabine
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Overall response rate [ Time Frame: Week 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 73
Study Start Date: November 2002
Study Completion Date: May 2005
Arms Assigned Interventions
Experimental: A 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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00635323

Locations
China
Pfizer Investigational Site
Shanghai, China, 200433
Hong Kong
Pfizer Investigational Site
Hong Kong SAR, Hong Kong
Korea, Republic of
Pfizer Investigational Site
Seoul, Korea, Republic of, 135-710
Pfizer Investigational Site
Seoul, Korea, Republic of, 138-736
Pfizer Investigational Site
Seoul, Korea, Republic of, 152-703
Pfizer Investigational Site
Seoul, Korea, Republic of, 136-705
Taiwan
Pfizer Investigational Site
Keelung, Taiwan, 204
Pfizer Investigational Site
Taipei, Taiwan, 112
Pfizer Investigational Site
Taipei, Taiwan
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00635323     History of Changes
Other Study ID Numbers: XRP4174/2501, A5961080
Study First Received: March 5, 2008
Last Updated: April 2, 2008
Health Authority: Korea: Independent Review Committee

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Carcinoma
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Capecitabine
Fluorouracil
Irinotecan
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Radiation-Sensitizing Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 22, 2014