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

This study is ongoing, but not recruiting participants.

Sponsored by: OSI Pharmaceuticals
Information provided by: OSI Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00072631
  Purpose

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 Intervention Phase
Advanced Non Small Cell Lung Cancer
Failed Prior Chemotherapy
Drug: Tarceva (Trademark) (erlotinib HCl, OSI-774)
Phase II

MedlinePlus related topics:   Cancer    Lung Cancer    Rashes   

Drug Information available for:   Erlotinib    Erlotinib hydrochloride   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by OSI Pharmaceuticals:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Feasibility of correlating objective response rate and duration of response to grade of rash [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Enrollment:   50
Study Start Date:   August 2003
Estimated Study Completion Date:   May 2008
Estimated Primary Completion Date:   May 2008 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental Drug: Tarceva (Trademark) (erlotinib HCl, OSI-774)
Intrapatient dose escalation of oral single agent daily erlotinib until intolerable rash

Detailed Description:

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

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00072631

Locations
United States, Texas
Institute for Drug DevelopmentCancer Therapy and Research Center    
      San Antonio, Texas, United States, 78229

Sponsors and Collaborators
OSI Pharmaceuticals
  More Information


Responsible Party:   OSI Pharmaceuticals, Inc. ( Karsten Witt, MD )
Study ID Numbers:   OSI-774-202, Dose to Rash
First Received:   November 5, 2003
Last Updated:   October 2, 2008
ClinicalTrials.gov Identifier:   NCT00072631
Health Authority:   United States: Food and Drug Administration;   Netherlands: Ministry of Health

Keywords provided by OSI Pharmaceuticals:
Tarceva  
erlotinib  
NSCLC  
Non-Small Cell Lung Cancer
EGFR
OSI-774

Study placed in the following topic categories:
Erlotinib
Thoracic Neoplasms
Non-small cell lung cancer
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2008




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