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 (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00518011
First received: August 16, 2007
Last updated: August 26, 2014
Last verified: August 2014
  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 patien ts with advanced non-small cell lung cancer. Patients will be randomized to rece ive 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 stu dy treatment is until disease progression, and the target sample size is 100-500 individuals.


Condition Intervention Phase
Non-Small Cell Lung Cancer
Drug: Gemcitabine
Drug: erlotinib [Tarceva]
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:


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 Start Date: August 2007
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Gemcitabine
As prescribed
Drug: erlotinib [Tarceva]
150mg po daily
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
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: NCT00518011

Locations
Australia
Auchenflower, Australia, 4066
Chermside, Australia, 4032
Footscray, Australia, 3011
Greenslopes, Australia, 4120
Lismore, Australia, 2480
Melbourne, Australia, 3084
Melbourne, Australia, 3002
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: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00518011     History of Changes
Other Study ID Numbers: ML20063
Study First Received: August 16, 2007
Last Updated: August 26, 2014
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 September 16, 2014