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

Phase 2

Completed

• Conditions: Non-Small Cell Lung Cancer
• Interventions: Drug: Tarceva (Trademark) (erlotinib HCl, OSI-774); Drug: Combination carboplatin and paclitaxel

• Registration Number: NCT00085839
• Lead Sponsor: OSI Pharmaceuticals

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-02
• Study First Submitted: 2004-06-15
• Study First Submitted QC: 2004-06-16
• Study First Posted: 2004-06-17
• Primary Completion: 2007-03
• Study Completion: 2007-03
• Results First Submitted: 2011-03-28
• Results First Submitted QC: 2011-03-28
• Results First Posted: 2011-04-22
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-06
• Last Update Posted: 2012-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Erlotinib	Tarceva (Trademark) (erlotinib HCl, OSI-774)	Erlotinib tablets administered orally, 150 mg/day (starting dose) or 100 mg/day (reduced dose), continuous therapy
Standard Chemotherapy	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

Primary Outcome Measures

Name	Time	Method
Progression-free Survival	Until time of disease progression (maximum 5 months)	Median time until disease progression. Disease progression defined as radiological and/or symptomatic disease progression or death in absence of progression.

Secondary Outcome Measures

Name	Time	Method
Overall Survival	From first study treatment until time of death (maximum 26.8 months)	Median number of months from first study treatment until time of death
Best Tumor Response	While receiving study treatment (maximum 60 weeks)	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.

Trial Locations

Locations (19)

California Cancer Care, Inc.; 🇺🇸 Greenbrae, California, United States

Sharp Clinical Oncology Research; 🇺🇸 San Diego, California, United States

Holy Cross Hospital; 🇺🇸 Fort Lauderdale, Florida, United States

Mount Sinai Cancer Center; 🇺🇸 Miami Beach, Florida, United States

University of Miami; 🇺🇸 Miami, Florida, United States

Evanston Northwestern Healthcare; 🇺🇸 Evanston, Illinois, United States

Oncology/Hematology Associates of Central Illinois; 🇺🇸 Peoria, Illinois, United States

Norton Healthcare, Inc.; 🇺🇸 Louisville, Kentucky, United States

Maryland Hematology/Oncology Associates; 🇺🇸 Baltimore, Maryland, United States

VA Sierra Nevada Health Care System; 🇺🇸 Reno, Nevada, United States

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