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Erlotinib (Tarceva) as a Single Agent or Intercalated With Combination Chemotherapy in Patients With EGFR Positive NSCLC

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( OSI Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00294762
First received: February 17, 2006
Last updated: August 6, 2012
Last verified: August 2012
  Purpose

This will be the first prospective study where patients will be selected on the basis of two measures of the epidermal growth factor receptor (EGFR) pathway. The study will assess prospectively the efficacy of erlotinib as a single agent or intercalated with chemotherapy in highly selected patients with EGFR overexpression and/or EGFR amplification.


Condition Intervention Phase
Carcinoma, Non-Small-Cell Lung
Drug: Tarceva
Drug: carboplatin
Drug: 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 Phase 2 Randomized Study of Tarceva (Erlotinib) as a Single Agent or Intercalated With Combination Chemotherapy in Patients With Newly Diagnosed Advanced Non-small Cell Lung Cancer Who Have Tumors With EGFR Protein Overexpression and/or Increased EGFR Gene Copy Numbers

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • 6-month Progression-free Survival [ Time Frame: 6 months after first dose ] [ Designated as safety issue: No ]
    Percentage of patients who's disease had not progressed at 6 months. Disease progression defined as radiological and/or symptomatic disease progression or death in absence of progression.


Secondary Outcome Measures:
  • Progression-free Survival [ Time Frame: Until time of disease progression, as assessed every 21 days (maximum 28.8 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.

  • Overall Survival at 12 Months [ Time Frame: 12 months from 1st dose ] [ Designated as safety issue: No ]
    Percentage of patients alive after 12 months of study treatment

  • Overall Survival [ Time Frame: From first study treatment until time of death (maximum 29.0 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; assessed every 21 days until progression (maximum 28.8 months) ] [ 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 larger than at baseline

  • Duration of Tumor Response [ Time Frame: While receiving study treatment; assessed every 21 days until progression (maximum 28.8 months). ] [ Designated as safety issue: No ]
    Median length of time that tumor showed any type of response, ie, CR, PR, or SD


Enrollment: 143
Study Start Date: January 2006
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Erlotinib
150 mg erlotinib daily
Drug: Tarceva
oral tablet
Other Names:
  • erlotinib
  • OSI-774
Experimental: Erlotinib + chemotherapy (intercalated)
carboplatin AUC 6 on Day 1 to 21 days, paclitaxel 200 mg/m2 on Day 1 to 21 days, erlotinib 150 mg Days 2-15 for 4 cycles then erlotinib 150 mg daily until progression, withdrawal of consent, or unacceptable toxicity
Drug: Tarceva
oral tablet
Other Names:
  • erlotinib
  • OSI-774
Drug: carboplatin
IV
Drug: paclitaxel
IV

  Eligibility

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

Inclusion Criteria:

  • Age >= 18
  • Histologically or cytologically documented non-small cell lung cancer (NSCLC)
  • Eastern Cooperative Oncology Group (ECOG)performance status (PS)0, 1, 2
  • Radiologically measurable or evaluable disease No prior chemotherapy
  • 1 or 2 epithelial growth factor receptor (EGFR) pathway markers positive at screening
  • Tumor tissue block or fine needle aspirate

Exclusion Criteria:

  • Any concurrent anticancer therapy or radiation
  • Other active malignancy
  • Uncontrolled brain metastases
  • GI abnormalities
  • Severe abnormalities of the cornea
  • Significant cardiac disease
  • Active infection
  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: NCT00294762

  Show 43 Study Locations
Sponsors and Collaborators
OSI Pharmaceuticals
  More Information

Additional Information:
No publications provided

Responsible Party: Astellas Pharma Inc ( OSI Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00294762     History of Changes
Other Study ID Numbers: OSI-774-203
Study First Received: February 17, 2006
Results First Received: October 5, 2010
Last Updated: August 6, 2012
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Astellas Pharma Inc:
NSCLC
Erlotinib
Tarceva
Lung Cancer

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

ClinicalTrials.gov processed this record on November 27, 2014