Erlotinib Re-Challenge for Recurrent EGFR-mutant Lung Cancer in Patients Who Previously Received Adjuvant Erlotinib or Gefitinib

Part of paid clinical trials in New York, New York.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT01189435
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • erlotinib — DRUG
    After baseline evaluation, patients will initiate treatment with erlotinib 150 mg daily, or at maximum previous tolerated dose. Initial response assessment will be done during the fourth week of therapy, during the eighth week of therapy, and then every 8 weeks thereafter. Patients will continue on therapy until disease progression by RECIST.

Study Details

The purpose of this study is to measure the ability of erlotinib to effectively treat recurrent lung cancer which carries an EGFR mutation lung cancer after prior treatment with erlotinib or gefitinib received in the post-surgical or post-radiation setting.

Key Dates

First listed
Aug 26, 2010
Start date
Aug 31, 2010
Status verified
Oct 2015
Primary completion
Jan 31, 2012
Completion
Jan 31, 2012

Study Design

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

Arms

  • Experimental: erlotinib
    This will be a single institution, single-arm, two-stage, open-label study of erlotinib in the treatment of patients with recurrent EGFR-mutant lung cancer following completion of adjuvant erlotinib or gefitinib therapy.

Primary Outcome Measure

To Examine the Objective Response Rate (ORR) of Single-agent Erlotinib [ Time Frame: 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-

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