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
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
Trial Locations
- Locations (43)
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
Pacific Shores Medical Group
🇺🇸Long Beach, California, United States
UCLA Medical Center
🇺🇸Los Angeles, California, United States
North Valley Hematology/Oncology Medical GroupThe Thomas and Dorothy Leavey Cancer Center
🇺🇸Northridge, California, 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
Scroll for more (33 remaining)Central Hematology Oncology Medical Group Inc.🇺🇸Alhambra, California, United States