Skip to main content
OpenTrials
Completed

NCT Number: NCT00072631

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Advanced Non Small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Failed Prior Chemotherapy Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Institute for Drug Development Cancer Therapy and Research Center

San Antonio, Texas, 78229, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Drug

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

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

Sponsors and collaborators

Lead sponsor

OSI Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2003
Primary completion
2007
Study completion
2007
First posted
Nov 7, 2003
Registry last updated
Feb 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.