Erlotinib vs. Standard Chemotherapy in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) and Eastern Cooperative Oncology Group (ECOG)Performance Status (PS) 2

Non-Small Cell Lung Cancer Clinical Trial

Official title:

A Randomized Phase II Study of Single Agent Erlotinib [Tarceva (TM), OSI-774] Versus Standard Chemotherapy in Patients With Previously Untreated Advanced NSCLC and a Poor Performance Status

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00085839
• Other study ID #: OSI-774-201
• Status: Completed
• Phase: Phase 2
• First received: June 15, 2004
• Last updated: August 6, 2012
• Start date: February 2004
• Est. completion date: March 2007

Study information

• Verified date: August 2012
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this noncomparative study is to obtain preliminary estimates of the efficacy of erlotinib and standard chemotherapy in patients with advanced, previously untreated nonsmall cell lung cancer (NSCLC) and an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 2. The study will also evaluate the safety of single-agent erlotinib in this patient population.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: March 2007
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Stage IIIB or IV Nonsmall cell lung cancer (NSCLC)

• No prior chemotherapy

• Eastern Cooperative Oncology Group (ECOG) Performance Status 2

• Clinically or radiologically measurable disease per RECIST criteria

Exclusion Criteria:

• Gastro-intestinal abnormalities

• Any concurrent anticancer therapy

• Prior treatment with epidermal growth factor receptor (EGFR) inhibitors of any kind

• Other active malignancies

• Uncontrolled brain metastases

• Severe abnormalities of the cornea

• Significant cardiac disease

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• Tarceva (Trademark) (erlotinib HCl, OSI-774)
Erlotinib tablets administered orally, 150 mg/day (starting dose) or 100 mg/day (reduced dose), continuous therapy
• Combination carboplatin and paclitaxel
Paclitaxel 200 mg/m^2 IV infusion over 3 hours and carboplatin AUC 6 mg/mL x min IV over 15 - 30 minutes, both given on Day 1 every 21 days for 4 cycles

Locations

Country	Name	City	State
United States	Maryland Hematology/Oncology Associates	Baltimore	Maryland
United States	FEK Addo, PC	Bismarck	North Dakota
United States	Gabrail Cancer Center	Canton	Ohio
United States	Charleston Hematology Oncology	Charleston	South Carolina
United States	University Hospitals of Cleveland	Cleveland	Ohio
United States	Ohio State University	Columbus	Ohio
United States	Evanston Northwestern Healthcare	Evanston	Illinois
United States	Holy Cross Hospital	Fort Lauderdale	Florida
United States	California Cancer Care, Inc.	Greenbrae	California
United States	East Tennessee Oncology/Hematology, PC	Knoxville	Tennessee
United States	Norton Healthcare, Inc.	Louisville	Kentucky
United States	University of Miami	Miami	Florida
United States	Mount Sinai Cancer Center	Miami Beach	Florida
United States	Sarah Cannon Cancer Center	Nashville	Tennessee
United States	Weill Medical College of Cornell University	New York	New York
United States	Oncology/Hematology Associates of Central Illinois	Peoria	Illinois
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania
United States	VA Sierra Nevada Health Care System	Reno	Nevada
United States	Sharp Clinical Oncology Research	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
OSI Pharmaceuticals

Country where clinical trial is conducted

United States, 

References & Publications (1)

Lilenbaum R, Axelrod R, Thomas S, Dowlati A, Seigel L, Albert D, Witt K, Botkin D. Randomized phase II trial of erlotinib or standard chemotherapy in patients with advanced non-small-cell lung cancer and a performance status of 2. J Clin Oncol. 2008 Feb 2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free Survival	Median time until disease progression. Disease progression defined as radiological and/or symptomatic disease progression or death in absence of progression.	Until time of disease progression (maximum 5 months)	No
Secondary	Overall Survival	Median number of months from first study treatment until time of death	From first study treatment until time of death (maximum 26.8 months)	No
Secondary	Best Tumor Response	Change in size of tumor: Complete Response (CR) = no measurable tumor; Partial Response (PR) = 30% decrease in size of measurable tumor; Stable Disease (SD) = measurable tumor size has not changed; Progressive Disease (PD) = measurable tumor 20% larger than at baseline.	While receiving study treatment (maximum 60 weeks)	No

External Links

•   Link to Prescribing Information