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A Study of Tarceva (Erlotinib) in Elderly Patients With Advanced Non-Small Cell Lung Cancer

This study has been completed.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01196078
First received: September 3, 2010
Last updated: March 15, 2011
Last verified: March 2011
History of Changes
  Purpose

This study will compare the efficacy and safety of Tarceva (erlotinib) and vinorelbine in chemo-naive elderly patients with advanced non-small cell lung cancer. Patients will be randomized to receive either Tarceva (150 mg po daily) or vinorelbine (60 mg/m2 on days 1 and 8 of cycle 1 and 80 mg/m2 for the other 21 days cycles). The anticipated time on study treatment is until disease progression.


Condition Intervention Phase
Non-Small Cell Lung Cancer
 Drug: erlotinib [Tarceva]
Drug: vinorelbine
 Phase 4

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 Phase II Randomized Trial of Erlotinib or Vinorelbine in Chemo-naive, Advanced, Non-Small-Cell Lung Cancer Patients Aged 70 Years or Older in Taiwan

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:
  • Response rate (partial and complete response) [ Time Frame: From baseline up to 6 months ] [ Designated as safety issue: No ]
  • Time to disease progression [ Time Frame: From baseline up to 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: From baseline up to 6 months ] [ Designated as safety issue: No ]
  • Progression-free survival [ Time Frame: From baseline up to 6 months ] [ Designated as safety issue: No ]
  • Incidence of adverse events [ Time Frame: From baseline up to 6 months ] [ Designated as safety issue: No ]

Enrollment: 116
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: erlotinib [Tarceva]
150 mg, orally once a day for up to 6 cycles of 21 days each
Active Comparator: 2 Drug: vinorelbine
60 mg/m2, orally on days 1 and 8 of cycle 1, 80 mg/m2 for the other cycles

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients, >=70 years of age
  • Non-small cell lung cancer
  • Naive to prior chemotherapy or specific immunotherapy
  • Presence of at least 1 measurable lesion

Exclusion Criteria:

  • Active non-controlled infection or disease
  • CNS metastases
  • Any other malignancies (other than adequately treated basal cell cancer of skin, or in situ cancer of the cervix)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01196078

Locations
Taiwan
Taipei, Taiwan
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Chair: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01196078     History of Changes
Other Study ID Numbers: ML20322
Study First Received: September 3, 2010
Last Updated: March 15, 2011
Health Authority: Taiwan: Department of Health

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
 Vinorelbine
Erlotinib
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013