Study of Erlotinib in Combination With Bortezomib

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT00895687
Phase
PHASE1
Status
Completed

Conditions

  • Advanced Cancer

Eligibility Criteria

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

Interventions

  • Erlotinib Hydrochloride — DRUG
    Beginning dose of 150 mg taken by mouth daily for 21-day cycle.
  • Bortezomib — DRUG
    Beginning dose of 1. mg/m\^2 by vein over about 1-5 minutes on Days 1, 4, 8, and 11 of each 21-day cycle.

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 Velcade (bortezomib). 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
24 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Erlotinib + Bortezomib
    Up to 4 dose levels of study drug combination tested with 3-6 participants enrolled at each dose level. Erlotinib beginning dose of 150 mg taken by mouth daily for 21-day cycle. Bortezomib beginning dose of 1. mg/m\^2 by vein over about 1-5 minutes on Days 1, 4, 8, and 11 of each 21-day cycle.

Primary Outcome Measure

Tumor Response [ Time Frame: Evaluation of response after two 21-day cycles of treatment ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas MD Anderson Cancer CenterHoustonTexas77030-

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University of Texas MD Anderson Cancer Center· Houston, TX

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