Erlotinib in Combination With Cetuximab

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT00895362
Phase
PHASE1
Status
Completed

Conditions

  • Advanced Cancers

Eligibility Criteria

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

Interventions

  • Erlotinib — DRUG
    Starting dose 100 mg by mouth 1 time every day for 28-day cycle (Pediatric starting dose 50 mg).
  • Cetuximab — DRUG
    Loading dose of 200 mg/m\^2 (maintenance 125 mg/m\^2) by vein 1 day every week of 28-day cycle, on Days 1, 8, 15 and 22. First dose given over 2 hours and over 1 hour each subsequent time.

Study Details

The goal of this clinical research study is to find the highest tolerable dose of Tarceva (erlotinib hydrochloride) that can safely be given in combination with Erbitux (cetuximab). The safety of this drug combination will also be studied.

Key Dates

First listed
May 8, 2009
Start date
Apr 30, 2009
Status verified
Jul 2015
Primary completion
Jul 31, 2015

Study Design

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

Arms

  • Experimental: Erlotinib + Cetuximab
    Erlotinib in Combination with Cetuximab

Primary Outcome Measure

Maximum Tolerated Dose (MTD) of Erlotinib in Combination with Cetuximab [ Time Frame: 28 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas MD Anderson Cancer CenterHoustonTexas77030-

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