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CompletedNCT00072631Updated Feb 8, 2018

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

A Phase 2 interventional study of Tarceva (Trademark) (erlotinib HCl, OSI-774) in Advanced Non Small Cell Lung Cancer and Failed Prior Chemotherapy, sponsored by OSI Pharmaceuticals. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-02-08.

Sponsored by OSI Pharmaceuticals · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
43
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

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

02

Conditions studied

  • Advanced Non Small Cell Lung Cancer
  • Failed Prior Chemotherapy

Keywords

  • Tarceva
  • erlotinib
  • NSCLC
  • Non-Small Cell Lung Cancer
  • EGFR
  • OSI-774
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's enrollment of 43 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

OSI Pharmaceuticals is the lead sponsor of 15 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
43 participants (actual)

Study arms

  • Experimental
    1 erlotinib

    Drug: Tarceva (Trademark) (erlotinib HCl, OSI-774)

Interventions

  • DrugTarceva (Trademark) (erlotinib HCl, OSI-774)

    Intrapatient dose escalation of oral single agent daily erlotinib until intolerable rash

06

What researchers measure

Primary outcomes

  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 outcomes

  1. Feasibility of correlating objective response rate and duration of response to grade of rash

    Time frame: 3 years

07

Study locations

1 site
  • Institute for Drug Development Cancer Therapy and Research Center
    San Antonio, Texas 78229, United States
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 8, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00072631
Lead sponsor
OSI Pharmaceuticals
Responsible party
Sponsor
First posted
Nov 7, 2003
Start date
Nov 5, 2003
Primary completion
Mar 14, 2007
Completion
Mar 14, 2007
Last update
Feb 8, 2018

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.

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