A Phase 2 Study of Tarceva for Untreated, Good Prognosis Patients With Advanced Non-Small Cell Lung Cancer

NCT00585533 | Completed Phase 2 Results DMC

• 2 other identifiers: HCI12555IRB# 00012555
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate Tarceva in a selected population of patients with untreated advanced non-small cell lung cancer who are anticipated to have a relatively good (indolent) prognosis based on clinical criteria. It is anticipated that selection will enrich for tumor characteristic that are likely to be benefited by EGFR inhibitor treatment (survival greater than 90 days). The goal of this strategy is to provide a less toxic, oral treatment for patients with advanced NSCLC that will not interfere with patients receiving chemotherapy at some point in the future and may prolong the time to chemotherapy related progression. Patients will remain on study until disease progresses, a decline in performance status, if patient cannot tolerate the side effects or develops symptoms requiring conventional chemotherapy.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Survival Rate at 6-months Chemotherapy-progression-free (CP-free)

  Will determine if 6-month chemotherapy-progression-free (CP-free) survival rate (using RECIST) is significantly higher than the historically observed 31%. A one-sided binomial test at a 5% nominal significance was used.

  6 months

Secondary Outcomes (1)

• Overall Survival

  24 months

Study Arms (1)

A

OTHER

Drug: Erlotinib (Tarceva)

Interventions

Erlotinib (Tarceva) DRUG

Erlotinib

Also known as: Tarceva

A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Performance status 0-1.
• Weight Loss \< 10% in preceding 3 months
• Age 18 years and older.
• Adjuvant chemotherapy allowed if \> 6 months from protocol entry
• Adequate Organ Function
• Liver enzymes \< 2X normal, bilirubin = normal
• Oxygen saturation\> 89% on room air unless chronically oxygen dependent (not cancer related)
• Creatinine \<2.0 mg

You may not qualify if:

• Not pregnant or lactating.
• No Clinical Brain Metastases
• No prior chemotherapy for systemic disease
• Imminent need for chemotherapy for impending organ dysfunction is not allowed

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Wallace Akerley, MD
• Organization: Huntsman Cancer Institute/University of Utah

wallace.akerley@hci.utah.edu

801-585-5986

Study Officials

• Wallace Akerley, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2007
• First Posted: January 3, 2008
• Study Start: June 1, 2004
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: July 30, 2013
• Results First Posted: November 21, 2012

Record last verified: 2013-07

Locations

US (1)