Erlotinib and Cetuximab in Treating Patients With Advanced Solid Tumors With Emphasis on Non-Small Cell Lung Cancer

Part of paid clinical trials in Sacramento, California.

Sponsor
University of California, Davis
Study ID
NCT00408499
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Lung Cancer
  • Unspecified Adult Solid Tumor, Protocol Specific

Eligibility Criteria

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

Interventions

  • cetuximab — DRUG
    Cetuximab will be administered intravenously weekly at the maximum tolerated dose (determined in Phase I portion of the study) on a 28 day cycle. Participants will be in this study for at least 2 cycles (8 weeks). If the evaluations show that this treatment has been effective against the participant's cancer, he/she will continue the therapy.
  • erlotinib — DRUG
    Erlotinib will be taken by mouth daily on a 28 day cycle. It is in tablet form. The dose will be determined in Phase I portion of the study. Participants will be in this study for at least 2 cycles (8 weeks). If the evaluations show that this treatment has been effective against the participant's cancer, he/she will continue the therapy.

Study Details

RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as cetuximab, 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. Giving erlotinib together with cetuximab may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of erlotinib and cetuximab and to see how well they work in treating patients with advanced solid tumors or progressive or recurrent stage III or stage IV non-small cell lung cancer.

Key Dates

First listed
Dec 7, 2006
Start date
Aug 31, 2006
Status verified
Jan 2017
Primary completion
Apr 30, 2009
Completion
Jan 31, 2013

Study Design

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

Arms

  • Experimental: Erlotinib + Cetuximab
    Daily erlotinib combined with weekly cetuximab

Primary Outcome Measure

Number of Patients Experiencing a DLT [ Time Frame: baseline through cycle 1 of treatment ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of California Davis Cancer CenterSacramentoCalifornia95817-

Find similar trials in Sacramento, CA

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
University of California Davis Cancer Center· Sacramento, CA

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