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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( OSI Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00085839
First received: June 15, 2004
Last updated: August 6, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Non-Small Cell Lung Cancer
Drug: Tarceva (Trademark) (erlotinib HCl, OSI-774)
Drug: Combination carboplatin and paclitaxel
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Progression-free Survival [ Time Frame: Until time of disease progression (maximum 5 months) ] [ Designated as safety issue: No ]
    Median time until disease progression. Disease progression defined as radiological and/or symptomatic disease progression or death in absence of progression.


Secondary Outcome Measures:
  • Overall Survival [ Time Frame: From first study treatment until time of death (maximum 26.8 months) ] [ Designated as safety issue: No ]
    Median number of months from first study treatment until time of death

  • Best Tumor Response [ Time Frame: While receiving study treatment (maximum 60 weeks) ] [ Designated as safety issue: No ]
    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.


Enrollment: 103
Study Start Date: February 2004
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Erlotinib
Erlotinib tablets administered orally, 150 mg/day (starting dose) or 100 mg/day (reduced dose), continuous therapy
Drug: Tarceva (Trademark) (erlotinib HCl, OSI-774)
Erlotinib tablets administered orally, 150 mg/day (starting dose) or 100 mg/day (reduced dose), continuous therapy
Active Comparator: Standard Chemotherapy
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
Drug: 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00085839

Locations
United States, California
California Cancer Care, Inc.
Greenbrae, California, United States, 94904
Sharp Clinical Oncology Research
San Diego, California, United States, 92123
United States, Florida
Holy Cross Hospital
Fort Lauderdale, Florida, United States, 33308
University of Miami
Miami, Florida, United States, 33136
Mount Sinai Cancer Center
Miami Beach, Florida, United States, 33140
United States, Illinois
Evanston Northwestern Healthcare
Evanston, Illinois, United States, 60201
Oncology/Hematology Associates of Central Illinois
Peoria, Illinois, United States, 61615
United States, Kentucky
Norton Healthcare, Inc.
Louisville, Kentucky, United States, 40202
United States, Maryland
Maryland Hematology/Oncology Associates
Baltimore, Maryland, United States, 21237
United States, Nevada
VA Sierra Nevada Health Care System
Reno, Nevada, United States, 89502
United States, New York
Weill Medical College of Cornell University
New York, New York, United States, 10021
United States, North Dakota
FEK Addo, PC
Bismarck, North Dakota, United States, 58503
United States, Ohio
Gabrail Cancer Center
Canton, Ohio, United States, 44718
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106
Ohio State University
Columbus, Ohio, United States, 43210-1240
United States, Pennsylvania
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
United States, South Carolina
Charleston Hematology Oncology
Charleston, South Carolina, United States, 29403
United States, Tennessee
East Tennessee Oncology/Hematology, PC
Knoxville, Tennessee, United States, 37920
Sarah Cannon Cancer Center
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
OSI Pharmaceuticals
  More Information

Additional Information:
Publications:
Responsible Party: Astellas Pharma Inc ( OSI Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00085839     History of Changes
Other Study ID Numbers: OSI-774-201
Study First Received: June 15, 2004
Results First Received: March 28, 2011
Last Updated: August 6, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:
Tarceva
NSCLC
EGFR
ECOG Performance Status 2
erlotinib
Non-Small Cell Lung Cancer
OSI-774

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carboplatin
Paclitaxel
Erlotinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 14, 2014