Phase 2
Completed N=51
A Study of Tarceva (Erlotinib) and Avastin (Bevacizumab) in Patients With Advanced or Metastatic Liver Cancer.
Source: ClinicalTrials.gov NCT00605722 ↗Enrolled (actual)
51
Serious AEs
37.3%
Results posted
Jul 2014
Primary outcomePrimary: Percentage of Participants With Progression-free Survival (PFS) — 35.3 percentage of participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Progression-free Survival (PFS) |
35.3 | — |
| SECONDARY Overall Response Rate (ORR) |
0.0; 5.9 | — |
| SECONDARY Disease Control Rate (DCR) |
52.9 | — |
| SECONDARY Time to Tumor Progression |
2.9 | — |
| SECONDARY Progression-free Survival (PFS) |
2.9 | — |
| SECONDARY Overall Survival (OS) |
10.7 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) |
19; 51 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00605722). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.