Erlotinib (Tarceva) as a Single Agent or Intercalated With Combination Chemotherapy in Patients With EGFR Positive NSCLC
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Interventions
- Registration Number
- NCT00294762
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 143
- 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
- Any concurrent anticancer therapy or radiation
- Other active malignancy
- Uncontrolled brain metastases
- GI abnormalities
- Severe abnormalities of the cornea
- Significant cardiac disease
- Active infection
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Erlotinib Tarceva 150 mg erlotinib daily Erlotinib + chemotherapy (intercalated) Tarceva 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 Erlotinib + chemotherapy (intercalated) paclitaxel 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 Erlotinib + chemotherapy (intercalated) carboplatin 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
- Primary Outcome Measures
Name Time Method 6-month Progression-free Survival 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
Name Time Method Progression-free Survival 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.
Overall Survival at 12 Months 12 months from 1st dose Percentage of patients alive after 12 months of study treatment
Overall Survival From first study treatment until time of death (maximum 29.0 months) Median number of months from first study treatment until time of death
Best Tumor Response 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
Duration of Tumor Response 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
Trial Locations
- Locations (43)
Alegent Healthcare
🇺🇸Omaha, Nebraska, United States
Hematology-Oncology Associates, SJ, PA - Virtua Health
🇺🇸Mount Holly, New Jersey, United States
Boston Baskin Cancer Groupd/b/a U. of Tennessee Cancer Inst.
🇺🇸Memphis, Tennessee, United States
Central Hematology Oncology Medical Group Inc.
🇺🇸Alhambra, California, United States
Comprehensive Blood and Cancer Center(Part of TORI network)
🇺🇸Bakersfield, California, United States
Bay Area Cancer Research Group
🇺🇸Concord, California, United States
Virginia K. Crosson Cancer Center
🇺🇸Fullerton, California, United States
Comprehensive Cancer Centers of Nevada
🇺🇸Henderson, Nevada, United States
Sansum Santa Barbara Medical Foundation Clinic
🇺🇸Santa Barbara, California, United States
Fletcher Allen Health Care
🇺🇸Burlington, Vermont, United States
The West Cancer Clinic
🇺🇸Memphis, Tennessee, United States
Norton Healthcare, Inc.
🇺🇸Louisville, Kentucky, United States
Cancer Specialists of Tidewater, Ltd.
🇺🇸Chesapeake, Virginia, United States
Mount Vernon Hospital
🇬🇧Middlesex, United Kingdom
University of Chicago Medical Center
🇺🇸Chicago, Illinois, United States
Hematology Oncology Centers of Northern Rockies Research
🇺🇸Billings, Montana, United States
Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Fred Hutchinson Cancer Research Center
🇺🇸Seattle, Washington, United States
Rush-Presbyterian-St.Luke's Med Ctr
🇺🇸Chicago, Illinois, United States
ACORN
🇺🇸Memphis, Tennessee, United States
Peterborough District Hospital
🇬🇧Cambridge, United Kingdom
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Providence Portland Medical Center
🇺🇸Portland, Oregon, United States
Pottsville Cancer Clinic
🇺🇸Pottsville, Pennsylvania, United States
CR UK
🇬🇧Cambridge, United Kingdom
Rocky Mountain Cancer CenterResearch Department
🇺🇸Denver, Colorado, United States
Univ. of Minnesota Cancer Center
🇺🇸Minneapolis, Minnesota, United States
University of Colorado Cancer Center
🇺🇸Aurora, Colorado, United States
Ventura County Hematology-Oncology Specialists
🇺🇸Oxnard, California, United States
Wilshire Oncology Medical GroupThe Robert and Beverly Lewis Family Cancer Care Center
🇺🇸Pomona, California, United States
Cancer Care Associates Medical Group, Inc.
🇺🇸Redondo Beach, California, United States
North Valley Hematology/Oncology Medical GroupThe Thomas and Dorothy Leavey Cancer Center
🇺🇸Northridge, California, United States
Pacific Shores Medical Group
🇺🇸Long Beach, California, United States
UCLA Medical Center
🇺🇸Los Angeles, California, United States
Santa Barbara Hematology Oncology Medical Group, Inc.
🇺🇸Santa Barbara, California, United States
Eastern Connecticut Hematology and Oncology Associates
🇺🇸Norwich, Connecticut, United States
Suburban Hematology-Oncology Associates
🇺🇸Lawrenceville, Georgia, United States
Gulfcoast Oncology Associates
🇺🇸Tampa, Florida, United States
MD Anderson Cancer Ctr - Orlando
🇺🇸Orlando, Florida, United States
Central Georgia Cancer Care, P.C.
🇺🇸Macon, Georgia, United States
Birmingham Heartlands Hospital
🇬🇧Birmingham, United Kingdom
University of Texas M.D. Anderson Cancer Center
🇺🇸Houston, Texas, United States
Beatson Oncology Centre
🇬🇧Glasgow, United Kingdom