Erlotinib vs. Standard Chemotherapy in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) and Eastern Cooperative Oncology Group (ECOG)Performance Status (PS) 2
This study has been completed.
Sponsor:
OSI Pharmaceuticals
Information provided by (Responsible Party):
Astellas Pharma Inc ( OSI Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00085839
First received: June 15, 2004
Last updated: August 6, 2012
Last verified: August 2012
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Purpose
The purpose of this noncomparative study is to obtain preliminary estimates of the efficacy of erlotinib and standard chemotherapy in patients with advanced, previously untreated nonsmall cell lung cancer (NSCLC) and an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 2. The study will also evaluate the safety of single-agent erlotinib in this patient population.
| Condition | Intervention | Phase |
|---|---|---|
|
Non-Small Cell Lung Cancer |
Drug: Tarceva (Trademark) (erlotinib HCl, OSI-774) Drug: Combination carboplatin and 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 Randomized Phase II Study of Single Agent Erlotinib [Tarceva (TM), OSI-774] Versus Standard Chemotherapy in Patients With Previously Untreated Advanced NSCLC and a Poor Performance Status |
Resource links provided by NLM:
Further study details as provided by Astellas Pharma Inc:
Primary Outcome Measures:
- Progression-free Survival [ Time Frame: Until time of disease progression (maximum 5 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.
Secondary Outcome Measures:
- Overall Survival [ Time Frame: From first study treatment until time of death (maximum 26.8 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 (maximum 60 weeks) ] [ 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 20% larger than at baseline.
| Enrollment: | 103 |
| Study Start Date: | February 2004 |
| Study Completion Date: | March 2007 |
| Primary Completion Date: | March 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Erlotinib
Erlotinib tablets administered orally, 150 mg/day (starting dose) or 100 mg/day (reduced dose), continuous therapy
|
Drug: Tarceva (Trademark) (erlotinib HCl, OSI-774)
Erlotinib tablets administered orally, 150 mg/day (starting dose) or 100 mg/day (reduced dose), continuous therapy
|
|
Active Comparator: Standard Chemotherapy
Paclitaxel 200 mg/m^2 IV infusion over 3 hours and carboplatin AUC 6 mg/mL x min IV over 15 - 30 minutes, both given on Day 1 every 21 days for 4 cycles
|
Drug: Combination carboplatin and paclitaxel
Paclitaxel 200 mg/m^2 IV infusion over 3 hours and carboplatin AUC 6 mg/mL x min IV over 15 - 30 minutes, both given on Day 1 every 21 days for 4 cycles
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Stage IIIB or IV Nonsmall cell lung cancer (NSCLC)
- No prior chemotherapy
- Eastern Cooperative Oncology Group (ECOG) Performance Status 2
- Clinically or radiologically measurable disease per RECIST criteria
Exclusion Criteria:
- Gastro-intestinal abnormalities
- Any concurrent anticancer therapy
- Prior treatment with epidermal growth factor receptor (EGFR) inhibitors of any kind
- Other active malignancies
- Uncontrolled brain metastases
- Severe abnormalities of the cornea
- Significant cardiac disease
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00085839
Locations
| United States, California | |
| California Cancer Care, Inc. | |
| Greenbrae, California, United States, 94904 | |
| Sharp Clinical Oncology Research | |
| San Diego, California, United States, 92123 | |
| United States, Florida | |
| Holy Cross Hospital | |
| Fort Lauderdale, Florida, United States, 33308 | |
| University of Miami | |
| Miami, Florida, United States, 33136 | |
| Mount Sinai Cancer Center | |
| Miami Beach, Florida, United States, 33140 | |
| United States, Illinois | |
| Evanston Northwestern Healthcare | |
| Evanston, Illinois, United States, 60201 | |
| Oncology/Hematology Associates of Central Illinois | |
| Peoria, Illinois, United States, 61615 | |
| United States, Kentucky | |
| Norton Healthcare, Inc. | |
| Louisville, Kentucky, United States, 40202 | |
| United States, Maryland | |
| Maryland Hematology/Oncology Associates | |
| Baltimore, Maryland, United States, 21237 | |
| United States, Nevada | |
| VA Sierra Nevada Health Care System | |
| Reno, Nevada, United States, 89502 | |
| United States, New York | |
| Weill Medical College of Cornell University | |
| New York, New York, United States, 10021 | |
| United States, North Dakota | |
| FEK Addo, PC | |
| Bismarck, North Dakota, United States, 58503 | |
| United States, Ohio | |
| Gabrail Cancer Center | |
| Canton, Ohio, United States, 44718 | |
| University Hospitals of Cleveland | |
| Cleveland, Ohio, United States, 44106 | |
| Ohio State University | |
| Columbus, Ohio, United States, 43210-1240 | |
| United States, Pennsylvania | |
| Thomas Jefferson University Hospital | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| United States, South Carolina | |
| Charleston Hematology Oncology | |
| Charleston, South Carolina, United States, 29403 | |
| United States, Tennessee | |
| East Tennessee Oncology/Hematology, PC | |
| Knoxville, Tennessee, United States, 37920 | |
| Sarah Cannon Cancer Center | |
| Nashville, Tennessee, United States, 37203 | |
Sponsors and Collaborators
OSI Pharmaceuticals
More Information
Additional Information:
Publications:
| Responsible Party: | Astellas Pharma Inc ( OSI Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT00085839 History of Changes |
| Other Study ID Numbers: | OSI-774-201 |
| Study First Received: | June 15, 2004 |
| Results First Received: | March 28, 2011 |
| Last Updated: | August 6, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Astellas Pharma Inc:
|
Tarceva NSCLC EGFR ECOG Performance Status 2 |
erlotinib Non-Small Cell Lung Cancer OSI-774 |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms 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 May 23, 2013