A Study of Tarceva (Erlotinib) and Avastin (Bevacizumab) in Patients With Advanced or Metastatic Liver Cancer.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00605722
First received: January 18, 2008
Last updated: October 7, 2013
Last verified: October 2013
  Purpose

This single arm study will evaluate the efficacy and safety of a combination of Tarceva and Avastin in patients with advanced or metastatic liver cancer. Patients will be treated with Tarceva 150mg po daily plus Avastin 5mg/kg i.v. every 2 weeks. The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals.


Condition Intervention Phase
Liver Cancer
Drug: bevacizumab [Avastin]
Drug: Tarceva
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 Single Arm, Open Label Study of First Line Treatment With Tarceva Plus Avastin on Progression-free Survival in Patients With Advanced or Metastatic Liver Cancer

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: Week 16 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall response rate, disease control rate, time to tumor progression, progression-free survival, overall survival. [ Time Frame: Event driven ] [ Designated as safety issue: No ]
  • AEs, laboratory parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 51
Study Start Date: March 2008
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: bevacizumab [Avastin]
5mg/kg iv on day 1 of each 2 week cycle
Drug: Tarceva
150mg po daily

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • advanced or metastatic liver cancer;
  • >=1 measurable lesion, not previously treated with local therapy within 4 weeks of enrollment.

Exclusion Criteria:

  • prior or concomitant systemic anti-cancer treatment for advanced disease;
  • patients at high risk of variceal bleeding;
  • clinically significant cardiovascular disease;
  • major surgery, open biopsy, or significant traumatic injury within 4 weeks of study start.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00605722

Locations
Korea, Republic of
Seoul, Korea, Republic of, 138-736
Philippines
Manila, Philippines, 1000
Taiwan
Kueishan, Taiwan, 333
Tainan, Taiwan, 704
Taipei, Taiwan, 106
Taipei, Taiwan, 00112
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00605722     History of Changes
Other Study ID Numbers: ML21213
Study First Received: January 18, 2008
Last Updated: October 7, 2013
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases
Bevacizumab
Erlotinib
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014