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A Study of Tarceva (Erlotinib) and Gemcitabine in Treatment-Naive Patients With Advanced Non-Small Cell Lung Cancer.

This study has been completed.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00518011
First received: August 16, 2007
Last updated: November 17, 2009
Last verified: November 2009
History of Changes
  Purpose

This 2 arm study will assess the efficacy and safety of Tarceva plus gemcitabine, compared with gemcitabine alone, in the treatment of chemotherapy-naive patients with advanced non-small cell lung cancer. Patients will be randomized to receive either Tarceva 150mg po daily plus gemcitabine on days 1, 8, 15 and every 4 weeks subsequently, or with gemcitabine monotherapy. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.


Condition Intervention Phase
Non-small Cell Lung Cancer
 Drug: erlotinib [Tarceva]
Drug: Gemcitabine
 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, Open Label Study Comparing the Effect of First-line Therapy With Tarceva + Gemcitabine Versus Gemcitabine Monotherapy on Treatment Response in Treatment-naïve Patients With Advanced Non-small Cell Lung Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Progression free survival [ Time Frame: Event driven ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall response rate, disease control rate, duration of response, overall survival. [ Time Frame: Event driven ] [ Designated as safety issue: No ]
  • AEs, SAEs, vital signs. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 17
Study Completion Date: July 2009
Arms Assigned Interventions
Experimental: 1 Drug: erlotinib [Tarceva]
150mg po daily
Drug: Gemcitabine
As prescribed
Active Comparator: 2 Drug: Gemcitabine
As prescribed

  Eligibility

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

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • non-small cell lung cancer, stage IIIb (with effusion) or stage IV with measurable disease ;
  • ECOG PS 2;
  • adequate organ function.

Exclusion Criteria:

  • prior chemotherapy or systemic anti-tumor therapy;
  • hypersensitivity to erlotinib;
  • any condition contraindicating the use of the study medication and/or impairing the interpretation of results and/or leading to treatment-related complications.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00518011

Locations
Australia
Brisbane, Australia, 4066
Chermside, Australia, 4032
Footscray, Australia, 3011
Greenslopes, Australia, 4120
Lismore, Australia, 2480
Melbourne, Australia, 3002
Melbourne, Australia, 3084
Parkville, Australia, 3052
Randwick, Australia, 2031
Richmond, Australia, 3121
St. Leonards, Australia, 2065
Sydney, Australia, 2139
Wodonga, Australia, 3690
Wollongong, Australia, 2500
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00518011     History of Changes
Other Study ID Numbers: ML20063
Study First Received: August 16, 2007
Last Updated: November 17, 2009
Health Authority: Australia: Cancer Trials Australia, Royal Melbourne Hospital

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
Gemcitabine
Erlotinib
Antimetabolites, Antineoplastic
 Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on May 19, 2013