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

NCT01189435 | Terminated Phase 2 Results DMC

• 1 other identifier: 10-097
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Cancer

Keywords

OSI-774, TARCEVA (ERLOTINIB); Lung; recurrent; 10-097; Gefitinib

Outcome Measures

Primary Outcomes (1)

• To Examine the Objective Response Rate (ORR) of Single-agent Erlotinib

  in recurrent EGFR-mutant lung cancer, given to patients who previously received adjuvant erlotinib or gefitinib

  2 years

Study Arms (1)

erlotinib

EXPERIMENTAL

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.

Drug: erlotinib

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.

erlotinib

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A history of stage I-IIIB NSCLC
• Previously underdone definitive surgery or radiation
• Received prior adjuvant treatment or neoadjuvant with erlotinib or gefitinib for a total of at least 3 months at any time
• Stopped adjuvant erlotinib or neoadjuvant at least 2 months prior to date of first imaging demonstrating recurrence
• Pathologic evidence of recurrent lung cancer, confirmed at MSKCC EGFR sensitizing mutation (point mutation in exons 18 or 21, or deletion in exon 19) must be documented in the primary or recurrent tumor
• Tissue from their recurrent tumor must be submitted for EGFR mutation testing, and to evaluate for the presence of the T790M mutation (results do not need to have been reported to be eligible)
• Measurable disease by RECIST; if received prior irradiation, then must have a target lesion outside the irradiated field
• Signed informed consent
• Age \> or = to 21 years old
• Persons of reproductive potential must agree to use an adequate method of contraception throughout treatment and for at least 4 weeks after study drug is stopped

You may not qualify if:

• Prior progressive disease while receiving erlotinib or gefitinib therapy
• Patients with known pre-existing interstitial lung disease
• Total bilirubin greater than 1.8 mg/dl, excepting patients known to have Gilbert's syndrome
• AST or ALT greater than five times the upper limit of normal
• Pregnant or lactating women
• Medically unfit for erlotinib therapy as determined by treating oncologist

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Lung Neoplasms; Recurrence

Interventions

Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Gregory Riely
• Organization: Memorial Sloan Kettering Cancer Center

rielyg@mskcc.org

646-888-4199

Study Officials

• Christopher Azzoli, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2010
• First Posted: August 26, 2010
• Study Start: August 1, 2010
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: November 18, 2015
• Results First Posted: April 21, 2015

Record last verified: 2015-10

Locations

US (1)