Skip to content

Carboplatin and Gemcitabine Combined With Celecoxib and/or Zileuton in Treating Patients With Advanced Non-Small Cell Lung Cancer

Randomized Phase II Study of Eicosanoid Pathway Modulators and Cytotoxic Chemotherapy in Advanced Non-Small Cell Lung Cancer

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00070486
Enrollment
140
Registered
2003-10-07
Start date
2003-12-31
Completion date
2011-05-31
Last updated
2016-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Keywords

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

Brief summary

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.

Detailed description

OBJECTIVES: Primary * Compare the efficacy of carboplatin and gemcitabine with celecoxib and/or zileuton, in terms of 7-month progression-free survival, in patients with advanced non-small cell lung cancer. Secondary * Compare the response rate, distribution of survival, and failure-free survival time of patients treated with these regimens. * Correlate CYFRA and serum vascular endothelial growth factor levels with response and survival of patients treated with these regimens. * Correlate cyclo-oxygenase-2 and 5-lipoxygenase expression with survival of patients treated with these regimens. 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. * Arm II: Patients receive gemcitabine and carboplatin as in arm I and oral celecoxib twice daily on days 1-21. * Arm III: Patients receive gemcitabine and carboplatin as in arm I, oral celecoxib as in arm II, and oral zileuton as in arm I. In all arms, treatment repeats every 21 days for 6 courses. Patients with responding or stable disease continue courses of zileuton and/or celecoxib in the absence of disease progression or unacceptable toxicity. 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.

Interventions

DRUGcarboplatin

given IV

DRUGcelecoxib

given PO

DRUGgemcitabine hydrochloride

given IV

given PO

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Alliance for Clinical Trials in Oncology
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No

Inclusion criteria

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) of 1 of the following cellular types: * Adenocarcinoma * Large cell * Squamous cell * Mixed * Meets 1 of the following staging criteria: * Stage IIIB disease with malignant pleural effusion, supraclavicular node involvement, or contralateral hilar nodes * Stage IIIB patients eligible for Cancer and Leukemia Group B protocols of combined chemotherapy and chest irradiation are not allowed * Stage IV disease * Measurable or nonmeasurable disease * Unidimensionally measurable lesions at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan * The following are considered nonmeasurable disease: * Bone lesions * Ascites * Pleural/pericardial effusion * Lymphangitis cutis/pulmonis * Abdominal masses that are not confirmed and followed by imaging techniques * Cystic lesions * Small lesions * No leptomeningeal disease * Symptomatic CNS metastases must be treated (e.g., surgery, radiotherapy, or gamma knife), neurologically stable, and off steroids PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 Life expectancy * Not specified Hematopoietic * Granulocyte count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic * Bilirubin no greater than 1.5 mg/dL * AST no greater than 2.0 times upper limit of normal Renal * Creatinine no greater than 1.5 mg/dL Cardiovascular * None of the following within the past 6 months: * Myocardial infarction * Unstable angina * Symptomatic congestive heart failure * Serious uncontrolled cardiac arrhythmia * Cerebrovascular accident * Transient ischemic attack * Symptomatic carotid artery or peripheral vascular disease * Deep vein thrombosis * Significant thromboembolic event Pulmonary * No pulmonary embolism within the past 6 months Gastrointestinal * No history of gastrointestinal (GI) bleeding * No history of peptic ulcer disease * No active GI bleeding Other * Not pregnant or nursing * No known hypersensitivity to aspirin, NSAIDs, or sulfonamides * No currently active second malignancy other than nonmelanoma skin cancer * Patients are not considered to have a currently active malignancy if they have completed therapy and are considered by their physician to be at less than 30% risk of relapse PRIOR CONCURRENT THERAPY: Biologic therapy * No prior immunotherapy for NSCLC Chemotherapy * No prior chemotherapy for NSCLC * No other concurrent chemotherapy Endocrine therapy * See Disease Characteristics * No concurrent chronic oral steroids * Concurrent episodic steroids for antiemetic purposes allowed * No concurrent hormonal therapy * Concurrent inhaled steroids allowed when medically indicated * Concurrent megestrol for appetite stimulation is allowed Radiotherapy * See Disease Characteristics * At least 2 weeks since prior radiotherapy and recovered Surgery * See Disease Characteristics * At least 2 weeks since prior surgery and recovered Other * No prior systemic treatments for NSCLC * No other concurrent investigational therapy * At least 1 week since prior nonsteroidal anti-inflammatory drugs (NSAIDs), including any of the following: * Rofecoxib * Choline magnesium trisalicylate * Ibuprofen * Naproxen * Etodolac * Oxaprozin * Diflunisal * Nabumetone * Tolmetin * Valdecoxib * No concurrent NSAIDs * No concurrent chronic aspirin * Concurrent aspirin no greater than 325 mg/day is allowed * No concurrent fluconazole * No concurrent leukotriene antagonists (e.g., zafirlukast, montelukast, or pranlukast)

Design outcomes

Primary

MeasureTime frame
Disease free survival9 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026