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


Phase 2
18 Years
N/A
Not Enrolling
Both
Lung Cancer

Thank you

Trial Information

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


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)


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Description:

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.

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Wallace Akerley, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Utah

Authority:

United States: Institutional Review Board

Study ID:

HCI12555

NCT ID:

NCT00585533

Start Date:

June 2004

Completion Date:

March 2012

Related Keywords:

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

Name

Location
University of Utah Salt Lake City, Utah