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

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 II

MedlinePlus related topics:

Cancer Liver Cancer

ChemIDplus related topics:

Irinotecan Irinotecan hydrochloride Capecitabine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

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

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
A: Experimental	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

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
	Taipei, Taiwan, 112
	Pfizer Investigational Site
	Keelung, Taiwan, 204
	Pfizer Investigational Site
	Taipei, Taiwan

Sponsors and Collaborators

Pfizer

Investigators


Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Link to ClinicalStudyResults.org Posting This link exits the ClinicalTrials.gov site

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

Study placed in the following topic categories:

Liver Diseases

Capecitabine

Digestive System Neoplasms

Carcinoma, Hepatocellular

Irinotecan

Liver neoplasms

Carcinoma

Liver Neoplasms

Digestive System Diseases

Gastrointestinal Neoplasms

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Hepatocellular carcinoma

Additional relevant MeSH terms:

Antimetabolites

Neoplasms

Antimetabolites, Antineoplastic

Neoplasms by Site

Neoplasms by Histologic Type

Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents

Therapeutic Uses

Enzyme Inhibitors

Antineoplastic Agents, Phytogenic

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 23, 2008

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00635323