Dasatinib in Treating Patients With Advanced Lung Cancer That Is No Longer Responding to Erlotinib or Gefitinib

Phase 2

Completed

• Conditions: Lung Cancer
• Interventions: Drug: dasatinib

• Registration Number: NCT00570401
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

RATIONALE: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying how well dasatinib works in treating patients with advanced lung cancer that is no longer responding to erlotinib or gefitinib.

Detailed Description

OBJECTIVES:

Primary

* To determine the overall response rate (complete response and partial response) in patients with acquired erlotinib hydrochloride- or gefitinib-resistant advanced adenocarcinoma of the lung treated with dasatinib.

Secondary

* To determine the progression-free survival and overall survival of patients treated with this drug.

* To determine the overall response rate in patients with EGFR T790M lung adenocarcinomas treated with this drug.

* To determine the progression-free survival and overall survival of patients with EGFR T790M lung adenocarcinomas treated with this drug.

* To determine the toxicity profile of dasatinib in these patients.

OUTLINE: Beginning 1 week after completion of erlotinib hydrochloride or gefitinib therapy, patients receive oral dasatinib twice daily. Treatment continues in the absence of disease progression or unacceptable toxicity.

Response is assessed by CT scan at 4 weeks, 8 weeks, and then every 8 weeks thereafter.

Study Timeline

• Study Start: 2006-06
• Study First Submitted: 2007-12-07
• Study First Submitted QC: 2007-12-07
• Study First Posted: 2007-12-10
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2015-12
• Results First Submitted: 2015-12-16
• Results First Submitted QC: 2015-12-16
• Last Update Submitted: 2015-12-16
• Results First Posted: 2016-01-22
• Last Update Posted: 2016-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dasatinib	dasatinib	Beginning 1 week after completion of erlotinib hydrochloride or gefitinib therapy, patients receive oral dasatinib twice daily. Treatment continues in the absence of disease progression or unacceptable toxicity. Response is assessed by CT scan at 4 weeks, 8 weeks, and then every 8 weeks thereafter.

Primary Outcome Measures

Name	Time	Method
Determine the Overall Objective Response	2 years	To determine the overall response rate in patients with acquired erlotinib hydrochloride- or gefitinibresistant advanced adenocarcinoma of the lung treated with dasatinib using the RECIST criteria. Response and progression will be evaluated in this study using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee.22 Changes in only the largest diameter (uni-dimensional measurement) of the tumor lesions are used in the RECIST.

Trial Locations

Locations (1)

Memorial Sloan-Kettering Cancer Center; 🇺🇸 New York, New York, United States