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Sponsors and Collaborators: |
Cancer and Leukemia Group B National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00126581 |
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving erlotinib together with carboplatin and paclitaxel may kill more tumor cells.
PURPOSE: This randomized phase II trial is studying how well giving erlotinib alone or together with carboplatin and paclitaxel works in treating patients with stage III or stage IV non-small cell lung cancer.
Condition | Intervention | Phase |
---|---|---|
Lung Cancer |
Drug: carboplatin Drug: erlotinib hydrochloride Drug: paclitaxel |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
Official Title: | A Phase II Randomized Study of OSI-774 (ERLOTINIB) (NSC #718781; IND#63, 383) With or Without Carboplatin/Paclitaxel in Patients With Previously Untreated Adenocarcinoma of the Lung Who Never Smoked or Were Former Light Smokers |
Estimated Enrollment: | 180 |
Study Start Date: | August 2005 |
Estimated Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Arm I: Experimental
Patients receive oral erlotinib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
Drug: erlotinib hydrochloride
Given orally
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Arm II: Experimental
Patients receive erlotinib as in arm I. Patients also receive paclitaxel IV over 1-3 hours and carboplatin IV over 15-30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses of treatment, patients may continue to receive erlotinib alone as above
|
Drug: carboplatin
Given IV
Drug: erlotinib hydrochloride
Given orally
Drug: paclitaxel
Given IV
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OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
PROJECTED ACCRUAL: A total of 180 patients (80 for arm I and 100 for arm II) will be accrued for this study within 1.5 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed primary non-small cell lung cancer (NSCLC)
Adenocarcinoma histology, including any of the following histologic variants:
Pathology block or unstained slides from initial or subsequent diagnosis available
Meets 1 of the following stage criteria:
Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR
10 mm by spiral CT scan
The following are considered non-measurable disease:
Meets 1 of the following criteria for smoking history:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Gastrointestinal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
No concurrent hormonal therapy except for the following:
Radiotherapy
Surgery
Other
Study Chair: | Pasi Janne, MD, PhD | Dana-Farber Cancer Institute |
Investigator: | Vincent A. Miller, MD | Memorial Sloan-Kettering Cancer Center |
Responsible Party: | Cancer and Leukemia Group B ( Richard L. Schilsky ) |
Study ID Numbers: | CDR0000437097, CALGB-30406 |
Study First Received: | August 2, 2005 |
Last Updated: | August 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00126581 History of Changes |
Health Authority: | United States: Food and Drug Administration |
adenocarcinoma of the lung adenosquamous cell lung cancer bronchoalveolar cell lung cancer |
stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer recurrent non-small cell lung cancer |
Erlotinib Thoracic Neoplasms Adenocarcinoma, Bronchiolo-Alveolar Antimitotic Agents Carboplatin Protein Kinase Inhibitors Recurrence Carcinoma Respiratory Tract Diseases Lung Neoplasms |
Paclitaxel Lung Diseases Tubulin Modulators Non-small Cell Lung Cancer Adenocarcinoma of Lung Adenocarcinoma Antineoplastic Agents, Phytogenic Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |
Erlotinib Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Mitosis Modulators Enzyme Inhibitors Antimitotic Agents Carboplatin Protein Kinase Inhibitors Pharmacologic Actions |
Carcinoma Neoplasms Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Paclitaxel Therapeutic Uses Lung Diseases Tubulin Modulators Antineoplastic Agents, Phytogenic Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |