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

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Roche

Status and phase

Completed
Phase 2

Conditions

Liver Cancer

Treatments

Drug: erlotinib (Tarceva)
Drug: bevacizumab (Avastin)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00605722
ML21213

Details and patient eligibility

About

This single arm study evaluated the efficacy and safety of a combination of Tarceva and Avastin in patients with advanced or metastatic liver cancer. Patients were treated with Tarceva 150 mg po daily plus Avastin 5 mg/kg intravenous (iv) every 2 weeks. The anticipated time on study treatment was until disease progression, and the target sample size was <100 individuals.

Enrollment

51 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

51 participants in 1 patient group

bevacizumab + erlotinib
Experimental group
Description:
Participants received bevacizumab (Avastin) 5 mg/kg intravenous (iv) on day 1 of each 2 week cycle plus erlotinib (Tarceva) 150 mg orally once a day until disease progression or unmanageable toxicity.
Treatment:
Drug: bevacizumab (Avastin)
Drug: erlotinib (Tarceva)

Trial contacts and locations

6

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Data sourced from clinicaltrials.gov

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