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

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ClinicalTrials.gov Identifier: NCT00294762
Recruitment Status : Completed
First Posted : February 22, 2006
Results First Posted : February 14, 2011
Last Update Posted : August 9, 2012
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( OSI Pharmaceuticals )

Brief Summary:
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 or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Drug: Tarceva Drug: carboplatin Drug: paclitaxel Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 143 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : January 2006
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 6-month Progression-free Survival [ Time Frame: 6 months after first dose ]
    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 :
  1. Progression-free Survival [ Time Frame: Until time of disease progression, as assessed every 21 days (maximum 28.8 months) ]
    Median time until disease progression. Disease progression defined as radiological and/or symptomatic disease progression or death in absence of progression.

  2. Overall Survival at 12 Months [ Time Frame: 12 months from 1st dose ]
    Percentage of patients alive after 12 months of study treatment

  3. Overall Survival [ Time Frame: From first study treatment until time of death (maximum 29.0 months) ]
    Median number of months from first study treatment until time of death

  4. Best Tumor Response [ Time Frame: While receiving study treatment; assessed every 21 days until progression (maximum 28.8 months) ]
    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

  5. Duration of Tumor Response [ Time Frame: While receiving study treatment; assessed every 21 days until progression (maximum 28.8 months). ]
    Median length of time that tumor showed any type of response, ie, CR, PR, or SD



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00294762


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Sponsors and Collaborators
OSI Pharmaceuticals

Additional Information:
Responsible Party: OSI Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00294762     History of Changes
Other Study ID Numbers: OSI-774-203
First Posted: February 22, 2006    Key Record Dates
Results First Posted: February 14, 2011
Last Update Posted: August 9, 2012
Last Verified: August 2012

Keywords provided by Astellas Pharma Inc ( OSI Pharmaceuticals ):
NSCLC
Erlotinib
Tarceva
Lung Cancer

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