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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00072631
Recruitment Status : Completed
First Posted : November 7, 2003
Last Update Posted : February 8, 2018
Information provided by (Responsible Party):
Astellas Pharma Inc ( 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.

Condition or disease Intervention/treatment Phase
Advanced Non Small Cell Lung Cancer Failed Prior Chemotherapy Drug: Tarceva (Trademark) (erlotinib HCl, OSI-774) Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : November 5, 2003
Actual Primary Completion Date : March 14, 2007
Actual Study Completion Date : March 14, 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rashes

Arm Intervention/treatment
Experimental: 1 erlotinib Drug: Tarceva (Trademark) (erlotinib HCl, OSI-774)
Intrapatient dose escalation of oral single agent daily erlotinib until intolerable rash

Primary Outcome Measures :
  1. Feasibility of intrapatient dose escalation of erlotinib HCI to introduce a characteristic, target rash, and evaluate the effect on objective response rate [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Feasibility of correlating objective response rate and duration of response to grade of rash [ Time Frame: 3 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00072631

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United States, Texas
Institute for Drug Development Cancer Therapy and Research Center
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
OSI Pharmaceuticals
Additional Information:
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Responsible Party: OSI Pharmaceuticals Identifier: NCT00072631    
Other Study ID Numbers: OSI-774-202
Dose to Rash
First Posted: November 7, 2003    Key Record Dates
Last Update Posted: February 8, 2018
Last Verified: June 2015
Keywords provided by Astellas Pharma Inc ( OSI Pharmaceuticals ):
Non-Small Cell Lung Cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action