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Completed

NCT Number: NCT00085839

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

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.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

California Cancer Care, Inc., Greenbrae, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 paclitaxel

Drug

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 outcomes

  1. Progression-free Survival

    Time frame: 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 outcomes

  1. Overall Survival

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

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

  2. Best Tumor Response

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

OSI Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Jun 17, 2004
Registry last updated
Aug 9, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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