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

OSI Pharmaceuticals103 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

103

Conditions

Non-Small Cell Lung Cancer

Interventions

Tarceva (Trademark) (erlotinib HCl, OSI-774)DRUG

Erlotinib tablets administered orally, 150 mg/day (starting dose) or 100 mg/day (reduced dose), continuous therapy

Combination carboplatin and paclitaxelDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (19)

California Cancer Care, Inc.

Greenbrae, California, United States

Sharp Clinical Oncology Research

San Diego, California, United States

Outcomes

Primary Outcomes

Progression-free Survival

Median time until disease progression. Disease progression defined as radiological and/or symptomatic disease progression or death in absence of progression.

Time frame: Until time of disease progression (maximum 5 months)

Secondary Outcomes

Overall Survival

Median number of months from first study treatment until time of death

Time frame: From first study treatment until time of death (maximum 26.8 months)

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.

Time frame: While receiving study treatment (maximum 60 weeks)

Data from ClinicalTrials.gov

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