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

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:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Paclitaxel Carboplatin Erlotinib hydrochloride Erlotinib

U.S. FDA Resources

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00294762

Show 43 Study Locations

Sponsors and Collaborators

OSI Pharmaceuticals

More Information

Additional Information:

OSI Pharmaceuticals website This link exits the ClinicalTrials.gov site

Link to Prescribing Information This link exits the ClinicalTrials.gov site

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
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases

Carboplatin
Paclitaxel
Erlotinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Protein Kinase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on June 18, 2013