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OpenTrials
Completed

NCT Number: NCT00635323

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

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

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Key information

Conditions

Carcinoma, Hepatocellular Adenocarcinoma Carcinoma Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Pfizer Investigational Site, Shanghai, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Irinotecan plus capecitabine

Drug

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 outcomes

  1. Overall response rate

    Time frame: Week 6

Secondary outcomes

  1. Time to progression

    Time frame: Weeks 6, 12, 18, 24, 36, and 1 year

  2. Duration of overall response

    Time frame: Weeks 6, 12, 18, 24, 36, and 1 year

  3. Overall tumour growth control rate

    Time frame: Weeks 6, 12, 18, 24, 36, and 1 year

  4. Overall survival

    Time frame: Weeks 6, 12, 18, 24, 36, and 1 year

  5. Adverse events

    Time frame: Weeks 6, 12, 18, 24, 36, and 1 year

  6. Physical exam

    Time frame: Weeks 6, 12, 18, 24, 36, and 1 year

  7. Laboratory tests

    Time frame: Weeks 6, 12, 18, 24, 36, and 1 year

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2002
Study completion
2005
First posted
Mar 13, 2008
Registry last updated
Apr 7, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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