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

Primary Purpose

Carcinoma, Hepatocellular

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Irinotecan plus capecitabine

About this trial

This is an interventional treatment trial for Carcinoma, Hepatocellular

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Overall response rate

Secondary Outcome Measures

Time to progression

Duration of overall response

Overall tumour growth control rate

Overall survival

Adverse events

Physical exam

Laboratory tests

Full Information

NCT ID

NCT00635323

First Posted

March 5, 2008

Last Updated

April 2, 2008

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00635323

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2008

Overall Recruitment Status

Completed

Study Start Date

November 2002 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

May 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Carcinoma, Hepatocellular

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

73 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Irinotecan plus capecitabine

Intervention Description

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

Primary Outcome Measure Information:

Title

Overall response rate

Time Frame

Week 6

Secondary Outcome Measure Information:

Title

Time to progression

Time Frame