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Sponsors and Collaborators: |
Cancer and Leukemia Group B National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00070486 |
RATIONALE: Drugs used in chemotherapy, such as carboplatin and gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Celecoxib and zileuton may stop the growth of tumor cells by stopping blood flow to the tumor and may block the enzymes necessary for tumor cell growth. Combining chemotherapy with celecoxib and/or zileuton may kill more tumor cells.
PURPOSE: Randomized phase II trial to study the effectiveness of combining celecoxib and/or zileuton with carboplatin and gemcitabine in treating patients who have advanced non-small cell lung cancer.
Condition | Intervention | Phase |
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Lung Cancer |
Drug: carboplatin Drug: celecoxib Drug: gemcitabine hydrochloride Drug: zileuton |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | Randomized Phase II Study of Eicosanoid Pathway Modulators and Cytotoxic Chemotherapy in Advanced Non-Small Cell Lung Cancer |
Study Start Date: | December 2003 |
Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 3 treatment arms.
Arm I: Patients receive gemcitabine IV over 30 minutes on days 1 and 8, carboplatin IV over 30 minutes on day
1, and oral zileuton 4 times daily on days 1-21.
Patients are followed monthly for 1 year, every 2 months for 2 years, and then every 4 months for 3 years or until disease progression.
PROJECTED ACCRUAL: A total of 117 patients (39 per treatment arm) will be accrued for this study within 11-12 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) of 1 of the following cellular types:
Meets 1 of the following staging criteria:
Stage IIIB disease with malignant pleural effusion, supraclavicular node involvement, or contralateral hilar nodes
Measurable or nonmeasurable disease
The following are considered nonmeasurable disease:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
None of the following within the past 6 months:
Pulmonary
Gastrointestinal
Other
No currently active second malignancy other than nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
No concurrent chronic oral steroids
Radiotherapy
Surgery
Other
At least 1 week since prior nonsteroidal anti-inflammatory drugs (NSAIDs), including any of the following:
No concurrent chronic aspirin
Study Chair: | Martin J. Edelman, MD | University of Maryland Greenebaum Cancer Center |
Study ID Numbers: | CDR0000334573, CALGB-30203 |
Study First Received: | October 3, 2003 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00070486 History of Changes |
Health Authority: | United States: Federal Government |
stage IV non-small cell lung cancer adenocarcinoma of the lung squamous cell lung cancer large cell lung cancer stage IIIB non-small cell lung cancer |
Thoracic Neoplasms Antimetabolites Anti-Inflammatory Agents Anti-Infective Agents Immunologic Factors Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Hormones Leukotriene Antagonists Respiratory Tract Diseases Lung Neoplasms Anti-Inflammatory Agents, Non-Steroidal Analgesics Gemcitabine Celecoxib |
Cyclooxygenase Inhibitors Carboplatin Antiviral Agents Immunosuppressive Agents Lipoxygenase Inhibitors Carcinoma Radiation-Sensitizing Agents Analgesics, Non-Narcotic Zileuton Lung Diseases Non-small Cell Lung Cancer Adenocarcinoma of Lung Peripheral Nervous System Agents Antirheumatic Agents Adenocarcinoma |
Anti-Inflammatory Agents Thoracic Neoplasms Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Leukotriene Antagonists Neoplasms by Site Respiratory Tract Diseases Sensory System Agents |
Lung Neoplasms Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Gemcitabine Respiratory Tract Neoplasms Neoplasms by Histologic Type Celecoxib Cyclooxygenase Inhibitors Enzyme Inhibitors Carboplatin Antiviral Agents Immunosuppressive Agents Lipoxygenase Inhibitors Pharmacologic Actions |