Efficacy and Safety Study of Bevacizumab and Erlotinib to Treat Primary Liver Cancer That Cannot be Removed By Surgery

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT00242502
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab (Avastin) — DRUG
    10 mg/kg IV every 14 days, repeat cycle every 28 days
  • Erlotinib — DRUG
    150 mg orally every day continuous dosing, repeat cycle every 28 days

Study Details

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).

Key Dates

First listed
Oct 20, 2005
Start date
Oct 31, 2005
Status verified
Mar 2013
Primary completion
Oct 31, 2011
Completion
Oct 31, 2011

Study Design

Enrollment
62 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Bevacizumab + Erlotinib
    Bevacizumab 10 mg/kg intravenous every 14 days, repeat cycle every 28 days; Erlotinib 150 mg orally every day continuous dosing.

Primary Outcome Measure

Progression-free Survival (PFS) Rate [ Time Frame: Baseline to 16 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
UT MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Houston, TX

By condition
Liver cancer
By specialty
OncologyGI oncologyHepatology
By research site
UT MD Anderson Cancer Center· Houston, TX

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