Erlotinib Re-Challenge for Recurrent EGFR-mutant Lung Cancer in Patients Who Previously Received Adjuvant Erlotinib or Gefitinib
This study has been terminated.
(Lack of accrual)
Sponsor:
Memorial Sloan-Kettering Cancer Center
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01189435
First received: August 25, 2010
Last updated: November 8, 2011
Last verified: November 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Drug: erlotinib |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 2 Trial of Erlotinib Re-Challenge for Recurrent EGFR-mutant Lung Cancer in Patients Who Previously Received Adjuvant Erlotinib or Gefitinib |
Resource links provided by NLM:
Further study details as provided by Memorial Sloan-Kettering Cancer Center:
Primary Outcome Measures:
- To examine the objective response rate (ORR) of single-agent erlotinib [ Time Frame: 2 years ] [ Designated as safety issue: No ]in recurrent EGFR-mutant lung cancer, given to patients who previously received adjuvant erlotinib or gefitinib
Secondary Outcome Measures:
- To examine the progression free survival (PFS) [ Time Frame: 2 years ] [ Designated as safety issue: No ]of patients receiving single-agent erlotinib for recurrent EGFR-mutant lung cancer following previous adjuvant erlotinib or gefitinib
- To examine overall survival (OS) [ Time Frame: 2 years ] [ Designated as safety issue: No ]of patients receiving single-agent erlotinib for recurrent EGFR-mutant lung cancer following previous adjuvant erlotinib or gefitinib
- To estimate the prevalence of EGFR T790M mutation [ Time Frame: 2 years ] [ Designated as safety issue: No ]in patients who have recurrent lung cancer after stopping adjuvant erlotinib or gefitinib
- To examine the correlation of T790M mutation [ Time Frame: 2 years ] [ Designated as safety issue: No ]with ORR and PFS in patients receiving erlotinib or gefitinib
- To estimate the accuracy of circulating tumor cells (CTCs) [ Time Frame: Within 2 weeks of starting erlotinib or gefitinib ] [ Designated as safety issue: No ]at non-invasively detecting EGFR and T790M mutations in patients with recurrent lung cancer.
| Enrollment: | 2 |
| Study Start Date: | August 2010 |
| Estimated Study Completion Date: | August 2012 |
| Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Drug: erlotinib
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.
|
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01189435
Locations
| United States, New York | |
| Memorial Sloan Kettering Cancer Center | |
| New York, New York, United States, 10065 | |
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
| Principal Investigator: | Christopher Azzoli, MD | Memorial Sloan-Kettering Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Memorial Sloan-Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01189435 History of Changes |
| Other Study ID Numbers: | 10-097 |
| Study First Received: | August 25, 2010 |
| Last Updated: | November 8, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Memorial Sloan-Kettering Cancer Center:
|
OSI-774, TARCEVA (ERLOTINIB) Lung recurrent 10-097 Gefitinib |
Additional relevant MeSH terms:
|
Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Adjuvants, Immunologic Gefitinib |
Erlotinib Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013