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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00585533
• Other study ID #: HCI12555
• Secondary ID: IRB# 00012555
• Status: Completed
• Phase: Phase 2
• First received: December 26, 2007
• Last updated: July 23, 2013
• Start date: June 2004
• Est. completion date: March 2012

Study information

• Verified date: July 2013
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

Primary Objective To determine Time to Chemotherapy Progression (ie includes time on Tarceva monotherapy and chemotherapy) in advanced NSCLC

Secondary Objectives To evaluate survival and response rate associated with Tarceva treatment To study the frequency of symptom improvement (Lung Cancer Subscale)

Other known NCT identifiers

• NCT00204724

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• Erlotinib (Tarceva)
Erlotinib

Locations

Country	Name	City	State
United States	University of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Overall Survival	Estimated via a Kaplan-Meier curves. Survival will be counted from the first dose of Tarceva.	24 months	No