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

Advanced Non Small Cell Lung Cancer Clinical Trial

Official title:

A Phase II, Open-label, Intra-patient Dose-escalation Study of Erlotinib in Patients With Advanced Non-small Cell Lung Cancer Who Have Failed Prior Chemotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00072631
• Other study ID #: OSI-774-202
• Secondary ID: Dose to Rash
• Status: Completed
• Phase: Phase 2
• First received: November 5, 2003
• Last updated: February 6, 2018
• Start date: November 5, 2003
• Est. completion date: March 14, 2007

Study information

• Verified date: June 2015
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: March 14, 2007
• Est. primary completion date: March 14, 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Non Small Cell Lung Cancer
• Carcinoma, Non-Small-Cell Lung
• Failed Prior Chemotherapy
• Lung Neoplasms

Intervention

Drug:
• Tarceva (Trademark) (erlotinib HCl, OSI-774)
Intrapatient dose escalation of oral single agent daily erlotinib until intolerable rash

Locations

Country	Name	City	State
United States	Institute for Drug Development Cancer Therapy and Research Center	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
OSI Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Feasibility of correlating objective response rate and duration of response to grade of rash		3 years

External Links

•   Link to results on Astellas Clinical Study Results website