Erlotinib Hydrochloride With or Without Cixutumumab in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer

Part of paid clinical trials in Denver, Colorado.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00778167
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Recurrent Non-small Cell Lung Cancer
  • Stage IIIA Non-small Cell Lung Cancer
  • Stage IIIB Non-small Cell Lung Cancer
  • Stage IV Non-small Cell Lung Cancer

Eligibility Criteria

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

Interventions

  • cixutumumab — BIOLOGICAL
    Given IV
  • erlotinib hydrochloride — DRUG
    Given PO
  • laboratory biomarker analysis — OTHER
    Correlative studies

Study Details

This randomized phase I/II trial is studying the side effects and best dose of cixutumumab and to see how well erlotinib hydrochloride works when given together with or without cixutumumab in treating patients with stage III or stage IV non-small cell lung cancer. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as cixutumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether erlotinib hydrochloride is more effective when given together with or without cixutumumab in treating non-small cell lung cancer.

Key Dates

First listed
Oct 23, 2008
Start date
Oct 31, 2008
Status verified
Mar 2013
Primary completion
May 31, 2012
Completion
May 31, 2012

Study Design

Enrollment
18 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm I (Enzyme inhibitor therapy)
    Patients receive erlotinib hydrochloride PO once daily on days 1-21. Patients with documented disease progression may cross over and receive treatment on arm II.
  • Experimental: Arm II (Enzyme inhibitor and monoclonal antibody therapy)
    Patients receive erlotinib hydrochloride PO as in arm I and cixutumumab IV over 1 hour on days 1, 8, and 15.

Primary Outcome Measure

Safety and Tolerability of IMC-A12 in Combination With Erlotinib Hydrochloride as Graded by Common Terminology Criteria for Adverse Event (CTCAE) Version 3.0 (DLTs During Cycle One) [ Time Frame: From time of first dose up to 28 days ]

Locations (2)

FacilityCityStateZIPSite coordinators
University of ColoradoDenverColorado80217-3364-
Roswell Park Cancer InstituteBuffaloNew York14263-

Find similar trials in Denver, CO

By research site
University of Colorado· Denver, CORoswell Park Cancer Institute· Buffalo, NY

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