Erlotinib (Tarceva (Trademark), OSI-774) in Treating Patients With Advanced Non-Small Cell Lung Cancer

Phase 2

Completed

• Conditions: Advanced Non Small Cell Lung Cancer; Failed Prior Chemotherapy
• Interventions: Drug: Tarceva (Trademark) (erlotinib HCl, OSI-774)

• Registration Number: NCT00072631
• Lead Sponsor: OSI Pharmaceuticals

Brief Summary

The purpose of this study is to determine if erlotinib will improve disease at doses that produce its characteristic rash in patients with advanced Non-Small Cell Lung Cancer.

Detailed Description

Only patients with 0 to 1 performance status on the ECOG scale are eligible.

Study Timeline

• Study Start: 2003-11-05
• Study First Submitted: 2003-11-05
• Study First Submitted QC: 2003-11-06
• Study First Posted: 2003-11-07
• Primary Completion: 2007-03-14
• Study Completion: 2007-03-14
• Status Verified: 2015-06
• Last Update Submitted: 2018-02-06
• Last Update Posted: 2018-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

• Confirmed diagnosis of Stage IIIB or IV non-small cell lung cancer (histological or cytological).
• Received prior chemotherapy treatment for advanced, metastatic non-small cell lung cancer.
• Measurable disease per RECIST criteria.
• Adequate bone marrow, hepatic and renal function.

Exclusion Criteria

• Breast cancer or skin cancer at any time in the past or any other cancer in the past 5 years.
• Brain metastases that are unstable, require steroids, are life-threatening or required radiation in the last 28 days.
• Known hypersensitivity to minocycline.
• History of serious cardiac disease that is not controlled.
• Serious eye conditions.
• Prior treatment with inhibitors of EGFR of any kind.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1 erlotinib	Tarceva (Trademark) (erlotinib HCl, OSI-774)	-

Primary Outcome Measures

Name	Time	Method
Feasibility of intrapatient dose escalation of erlotinib HCI to introduce a characteristic, target rash, and evaluate the effect on objective response rate	3 years

Secondary Outcome Measures

Name	Time	Method
Feasibility of correlating objective response rate and duration of response to grade of rash	3 years

Trial Locations

Locations (1)

Institute for Drug Development Cancer Therapy and Research Center; 🇺🇸 San Antonio, Texas, United States