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Clinical Trial Name - Carboplatin and Gemcitabine Combined With Celecoxib and/or Zileuton in Treating Patients With Adva
| Original Study ID : CDR0000334573 |
| Secondary ID : CALGB-30203 |
| NCT ID : NCT00070486 |
| Brief Title : Carboplatin and Gemcitabine Combined With Celecoxib and/or Zileuton in Treating Patients With Advanced Non-Small Cell Lung Cancer |
| Official Title : Randomized Phase II Study of Eicosanoid Pathway Modulators and Cytotoxic Chemotherapy in Advanced 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. |
| Source : National Cancer Institute (NCI) |
| 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. |
| Overall Status : Completed |
| Start Date : December 2003 |
| Official Title : Phase 2 |
| Phase : Interventional |
| Study Design : Treatment, Randomized, Active Control |
| Verification Date : July 2004 |
| First Received Date : October 3, 2003 |
| Trial Eligibility |
| 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) |
| Gender : Both |
| Minimum Age : 18 Years |
| Maximum Age : N/A |
| Healthy Volunteers : No |
| Facilities |
| Facility Name : Northeast Alabama Regional Medical Center |
| City : Anniston |
| State : Alabama |
| Zip Code : 36207 |
| Country : United States |
| Facility Name : Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center |
| City : Los Angeles |
| State : California |
| Zip Code : 90048 |
| Country : United States |
| Facility Name : Naval Medical Center - San Diego |
| City : San Diego |
| State : California |
| Zip Code : 92134-3202 |
| Country : United States |
| Facility Name : Rebecca and John Moores UCSD Cancer Center |
| City : La Jolla |
| State : California |
| Zip Code : 92093-0658 |
| Country : United States |
| Facility Name : UCSF Comprehensive Cancer Center |
| City : San Francisco |
| State : California |
| Zip Code : 94115 |
| Country : United States |
| Facility Name : Veterans Affairs Medical Center - San Diego |
| City : San Diego |
| State : California |
| Zip Code : 92161 |
| Country : United States |
| Facility Name : Veterans Affairs Medical Center - San Francisco |
| City : San Francisco |
| State : California |
| Zip Code : 94121 |
| Country : United States |
| Facility Name : CCOP - Christiana Care Health Services |
| City : Newark |
| State : Delaware |
| Zip Code : 19713 |
| Country : United States |
| Facility Name : Lombardi Cancer Center at Georgetown University Medical Center |
| City : Washington |
| State : District of Columbia |
| Zip Code : 20007 |
| Country : United States |
| Facility Name : Veterans Affairs Medical Center - Washington, DC |
| City : Washington |
| State : District of Columbia |
| Zip Code : 20422 |
| Country : United States |
| Facility Name : Walter Reed Army Medical Center |
| City : Washington |
| State : District of Columbia |
| Zip Code : 20307-5001 |
| Country : United States |
| Facility Name : Broward General Medical Center |
| City : Fort Lauderdale |
| State : Florida |
| Zip Code : 33316 |
| Country : United States |
| Facility Name : CCOP - Mount Sinai Medical Center |
| City : Miami Beach |
| State : Florida |
| Zip Code : 33140 |
| Country : United States |
| Facility Name : Memorial Regional Cancer Center at Memorial Regional Hospital |
| City : Hollywood |
| State : Florida |
| Zip Code : 33021 |
| Country : United States |
| Facility Name : Palm Beach Cancer Institute |
| City : West Palm Beach |
| State : Florida |
| Zip Code : 33401 |
| Country : United States |
| Facility Name : CCOP - Evanston |
| City : Evanston |
| State : Illinois |
| Zip Code : 60201 |
| Country : United States |
| Facility Name : CCOP - Illinois Oncology Research Association |
| City : Peoria |
| State : Illinois |
| Zip Code : 61602 |
| Country : United States |
| Facility Name : Louis A. Weiss Memorial Hospital |
| City : Chicago |
| State : Illinois |
| Zip Code : 60640 |
| Country : United States |
| Facility Name : MBCCOP - University of Illinois at Chicago |
| City : Chicago |
| State : Illinois |
| Zip Code : 60612 |
| Country : United States |
| Facility Name : University of Chicago Cancer Research Center |
| City : Chicago |
| State : Illinois |
| Zip Code : 60637-1470 |
| Country : United States |
| Facility Name : Veterans Affairs Medical Center - Chicago (Westside Hospital) |
| City : Chicago |
| State : Illinois |
| Zip Code : 60612 |
| Country : United States |
| Facility Name : West Suburban Center for Cancer Care |
| City : River Forest |
| State : Illinois |
| Zip Code : 60305 |
| Country : United States |
| Facility Name : CCOP - Northern Indiana CR Consortium |
| City : South Bend |
| State : Indiana |
| Zip Code : 46601 |
| Country : United States |
| Facility Name : Fort Wayne Medical Oncology and Hematology, Incorporated |
| City : Fort Wayne |
| State : Indiana |
| Zip Code : 46885-5099 |
| Country : United States |
| Facility Name : Holden Comprehensive Cancer Center at University of Iowa |
| City : Iowa City |
| State : Iowa |
| Zip Code : 52242-1009 |
| Country : United States |
| Facility Name : Baptist Hospital East - Louisville |
| City : Louisville |
| State : Kentucky |
| Zip Code : 40207 |
| Country : United States |
| Facility Name : Greenebaum Cancer Center at University of Maryland Medical Center |
| City : Baltimore |
| State : Maryland |
| Zip Code : 21201 |
| Country : United States |
| Facility Name : Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute |
| City : Boston |
| State : Massachusetts |
| Zip Code : 02115 |
| Country : United States |
| Facility Name : University of Massachusetts Memorial Medical Center - University Campus |
| City : Worcester |
| State : Massachusetts |
| Zip Code : 01655 |
| Country : United States |
| Facility Name : Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph |
| City : Saint Joseph |
| State : Michigan |
| Zip Code : 49085 |
| Country : United States |
| Facility Name : University of Minnesota Cancer Center |
| City : Minneapolis |
| State : Minnesota |
| Zip Code : 55455 |
| Country : United States |
| Facility Name : Veterans Affairs Medical Center - Minneapolis |
| City : Minneapolis |
| State : Minnesota |
| Zip Code : 55417 |
| Country : United States |
| Facility Name : CCOP - Kansas City |
| City : Kansas City |
| State : Missouri |
| Zip Code : 64131 |
| Country : United States |
| Facility Name : Ellis Fischel Cancer Center at University of Missouri - Columbia |
| City : Columbia |
| State : Missouri |
| Zip Code : 65203 |
| Country : United States |
| Facility Name : Missouri Baptist Cancer Center |
| City : Saint Louis |
| State : Missouri |
| Zip Code : 63131 |
| Country : United States |
| Facility Name : Siteman Cancer Center |
| City : Saint Louis |
| State : Missouri |
| Zip Code : 63110 |
| Country : United States |
| Facility Name : Veterans Affairs Medical Center - Columbia (Truman Memorial) |
| City : Columbia |
| State : Missouri |
| Zip Code : 65201 |
| Country : United States |
| Facility Name : UNMC Eppley Cancer Center at the University of Nebraska Medical Center |
| City : Omaha |
| State : Nebraska |
| Zip Code : 68198-7680 |
| Country : United States |
| Facility Name : CCOP - Southern Nevada Cancer Research Foundation |
| City : Las Vegas |
| State : Nevada |
| Zip Code : 89106 |
| Country : United States |
| Facility Name : Veterans Affairs Medical Center - Las Vegas |
| City : Las Vegas |
| State : Nevada |
| Zip Code : 89106 |
| Country : United States |
| Facility Name : New Hampshire Oncology-Hematology, PA - Hooksett |
| City : Hooksett |
| State : New Hampshire |
| Zip Code : 03106 |
| Country : United States |
| Facility Name : Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center |
| City : Lebanon |
| State : New Hampshire |
| Zip Code : 03756-0002 |
| Country : United States |
| Facility Name : Cooper University Hospital |
| City : Camden |
| State : New Jersey |
| Zip Code : 08103 |
| Country : United States |
| Facility Name : CCOP - North Shore University Hospital |
| City : Manhasset |
| State : New York |
| Zip Code : 11030 |
| Country : United States |
| Facility Name : CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. |
| City : East Syracuse |
| State : New York |
| Zip Code : 13057 |
| Country : United States |
| Facility Name : Memorial Sloan-Kettering Cancer Center |
| City : New York |
| State : New York |
| Zip Code : 10021 |
| Country : United States |
| Facility Name : Mount Sinai Medical Center |
| City : New York |
| State : New York |
| Zip Code : 10029 |
| Country : United States |
| Facility Name : New York Weill Cornell Cancer Center at Cornell University |
| City : New York |
| State : New York |
| Zip Code : 10021 |
| Country : United States |
| Facility Name : North Shore University Hospital |
| City : Manhasset |
| State : New York |
| Zip Code : 11030 |
| Country : United States |
| Facility Name : Queens Cancer Center of Queens Hospital |
| City : Jamaica |
| State : New York |
| Zip Code : 11432 |
| Country : United States |
| Facility Name : University Hospital at State University of New York - Upstate Medical University |
| City : Syracuse |
| State : New York |
| Zip Code : 13210 |
| Country : United States |
| Facility Name : Veterans Affairs Medical Center - Buffalo |
| City : Buffalo |
| State : New York |
| Zip Code : 14215 |
| Country : United States |
| Facility Name : Veterans Affairs Medical Center - Syracuse |
| City : Syracuse |
| State : New York |
| Zip Code : 13210 |
| Country : United States |
| Facility Name : Cape Fear Valley Health System |
| City : Fayetteville |
| State : North Carolina |
| Zip Code : 28302-2000 |
| Country : United States |
| Facility Name : CCOP - Southeast Cancer Control Consortium |
| City : Goldsboro |
| State : North Carolina |
| Zip Code : 27534-9479 |
| Country : United States |
| Facility Name : Comprehensive Cancer Center at Wake Forest University |
| City : Winston-Salem |
| State : North Carolina |
| Zip Code : 27157-1082 |
| Country : United States |
| Facility Name : Duke Comprehensive Cancer Center |
| City : Durham |
| State : North Carolina |
| Zip Code : 27710 |
| Country : United States |
| Facility Name : FirstHealth Moore Regional Hospital |
| City : Pinehurst |
| State : North Carolina |
| Zip Code : 28374 |
| Country : United States |
| Facility Name : Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill |
| City : Chapel Hill |
| State : North Carolina |
| Zip Code : 27599-7295 |
| Country : United States |
| Facility Name : NorthEast Oncology Associates - Concord |
| City : Concord |
| State : North Carolina |
| Zip Code : 28025 |
| Country : United States |
| Facility Name : Veterans Affairs Medical Center - Asheville |
| City : Asheville |
| State : North Carolina |
| Zip Code : 28805 |
| Country : United States |
| Facility Name : Veterans Affairs Medical Center - Durham |
| City : Durham |
| State : North Carolina |
| Zip Code : 27705 |
| Country : United States |
| Facility Name : Zimmer Cancer Center at New Hanover Regional Medical Center |
| City : Wilmington |
| State : North Carolina |
| Zip Code : 28402-9025 |
| Country : United States |
| Facility Name : Arthur G. James Cancer Hospital at Ohio State University |
| City : Columbus |
| State : Ohio |
| Zip Code : 43210-1240 |
| Country : United States |
| Facility Name : Oklahoma University Medical Center |
| City : Oklahoma City |
| State : Oklahoma |
| Zip Code : 73104 |
| Country : United States |
| Facility Name : Western Pennsylvania Hospital |
| City : Pittsburgh |
| State : Pennsylvania |
| Zip Code : 15224 |
| Country : United States |
| Facility Name : Lifespan: The Miriam Hospital |
| City : Providence |
| State : Rhode Island |
| Zip Code : 02906 |
| Country : United States |
| Facility Name : Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas |
| City : Dallas |
| State : Texas |
| Zip Code : 75390-8852 |
| Country : United States |
| Facility Name : Veterans Affairs Medical Center - Dallas |
| City : Dallas |
| State : Texas |
| Zip Code : 75219 |
| Country : United States |
| Facility Name : Vermont Cancer Center at University of Vermont |
| City : Burlington |
| State : Vermont |
| Zip Code : 05401-3498 |
| Country : United States |
| Facility Name : Martha Jefferson Hospital |
| City : Charlottesville |
| State : Virginia |
| Zip Code : 22902 |
| Country : United States |
| Facility Name : MBCCOP - Massey Cancer Center |
| City : Richmond |
| State : Virginia |
| Zip Code : 23298-0037 |
| Country : United States |
| Facility Name : Oncology and Hematology Associates of Southwest Virginia, Incorporated - Roanoke |
| City : Roanoke |
| State : Virginia |
| Zip Code : 24014 |
| Country : United States |
| Facility Name : Virginia Oncology Associates - Norfolk |
| City : Norfolk |
| State : Virginia |
| Zip Code : 23502 |
| Country : United States |
| Facility Name : St. Mary's Medical Center |
| City : Huntington |
| State : West Virginia |
| Zip Code : 25701 |
| Country : United States |
| Interventions |
| Type : Drug |
| Name : carboplatin |
| Type : Drug |
| Name : celecoxib |
| Type : Drug |
| Name : gemcitabine hydrochloride |
| Type : Drug |
| Name : zileuton |
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