CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 62 enrolled
Drug / intervention
Bevacizumab (Avastin) +1 moredrug
Likely dose
Bevacizumab 10 mg/kg IV every 14 days (28-day cycle) plus erlotinib 150 mg orally dailyAI-extracted
Key inclusion· 6
  • Histologically confirmed hepatocellular carcinoma not amenable to curative resection
  • Measurable disease per RECIST criteria
  • Up to one prior systemic therapy allowed, with any prior therapy completed ≥30 days prior to study entry
  • ECOG performance status ≤2
Key exclusion· 22
  • Prior VEGF- or EGFR-targeted therapy
  • Prior malignancy other than non-melanoma skin cancer or cervical dysplasia within 5 years
  • History of ruptured HCC or HCC with large necrotic areas
  • Corneal abnormalities (dry eye syndrome, Sjögren's syndrome, Fuchs' dystrophy)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00242502
NCT00242502Phase 2Completed

A Phase II Study of the Combination of Bevacizumab and Erlotinib in Patients With Unresectable Hepatocellular Carcinoma

M.D. Anderson Cancer Center·interventional·Posted Oct 20, 2005·Updated May 6, 2013

In Brief

A Phase 2 clinical trial evaluating Bevacizumab (Avastin) and Erlotinib for Hepatocellular Carcinoma and Liver Cancer. Completed, enrolled 62 participants across 1 site.

Detailed Summary

The primary objective will be to assess progression-free survival (PFS) measured at 16 weeks following initiation of therapy with the combination of Avastin and erlotinib in patients with unresectable hepatocellular carcinoma (HCC). Progression-free survival is defined as the time from initiation of therapy until documented disease progression or death. Secondary objectives include: response rate, median and overall survival, toxicity and tolerability, and to ascertain whether there is any correlation of response with prior treatment status and underlying HCC risk factor(s).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsGenentech, Inc.

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 20, 2005
Enrollment StartOct 1, 2005
Primary CompletionOct 1, 2011
TodayJul 2, 2026
Enrollment to primary: 6 yearsPosted 20.7 years ago

Interventions

Bevacizumab (Avastin)drug

10 mg/kg IV every 14 days, repeat cycle every 28 days

Erlotinibdrug

150 mg orally every day continuous dosing, repeat cycle every 28 days