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

February 6, 2018 updated by: OSI Pharmaceuticals

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78229
        • Institute for Drug Development Cancer Therapy and Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Feasibility of correlating objective response rate and duration of response to grade of rash
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

OSI Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 5, 2003

Primary Completion (Actual)

March 14, 2007

Study Completion (Actual)

March 14, 2007

Study Registration Dates

First Submitted

November 5, 2003

First Submitted That Met QC Criteria

November 6, 2003

First Posted (Estimate)

November 7, 2003

Study Record Updates

Last Update Posted (Actual)

February 8, 2018

Last Update Submitted That Met QC Criteria

February 6, 2018

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OSI-774-202
  • Dose to Rash

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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