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

Information source: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Lung Cancer

Intervention: carboplatin (Drug); celecoxib (Drug); gemcitabine hydrochloride (Drug); zileuton (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Alliance for Clinical Trials in Oncology

Official(s) and/or principal investigator(s):
Martin J. Edelman, MD, Study Chair, Affiliation: University of Maryland Greenebaum Cancer Center

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.

Clinical Details

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

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Disease free survival

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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)

Locations and Contacts

Northeast Alabama Regional Medical Center, Anniston, Alabama 36207, United States

Rebecca and John Moores UCSD Cancer Center, La Jolla, California 92093-0658, United States

Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center, Los Angeles, California 90048, United States

Naval Medical Center - San Diego, San Diego, California 92134-3202, United States

Veterans Affairs Medical Center - San Diego, San Diego, California 92161, United States

UCSF Comprehensive Cancer Center, San Francisco, California 94115, United States

Veterans Affairs Medical Center - San Francisco, San Francisco, California 94121, United States

CCOP - Christiana Care Health Services, Newark, Delaware 19713, United States

Lombardi Cancer Center at Georgetown University Medical Center, Washington, District of Columbia 20007, United States

Veterans Affairs Medical Center - Washington, DC, Washington, District of Columbia 20422, United States

Walter Reed Army Medical Center, Washington, District of Columbia 20307-5001, United States

Broward General Medical Center, Fort Lauderdale, Florida 33316, United States

Memorial Regional Cancer Center at Memorial Regional Hospital, Hollywood, Florida 33021, United States

CCOP - Mount Sinai Medical Center, Miami Beach, Florida 33140, United States

Palm Beach Cancer Institute, West Palm Beach, Florida 33401, United States

Louis A. Weiss Memorial Hospital, Chicago, Illinois 60640, United States

MBCCOP - University of Illinois at Chicago, Chicago, Illinois 60612, United States

University of Chicago Cancer Research Center, Chicago, Illinois 60637-1470, United States

Veterans Affairs Medical Center - Chicago (Westside Hospital), Chicago, Illinois 60612, United States

CCOP - Evanston, Evanston, Illinois 60201, United States

CCOP - Illinois Oncology Research Association, Peoria, Illinois 61602, United States

West Suburban Center for Cancer Care, River Forest, Illinois 60305, United States

Fort Wayne Medical Oncology and Hematology, Incorporated, Fort Wayne, Indiana 46885-5099, United States

CCOP - Northern Indiana CR Consortium, South Bend, Indiana 46601, United States

Holden Comprehensive Cancer Center at University of Iowa, Iowa City, Iowa 52242-1009, United States

Baptist Hospital East - Louisville, Louisville, Kentucky 40207, United States

Greenebaum Cancer Center at University of Maryland Medical Center, Baltimore, Maryland 21201, United States

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute, Boston, Massachusetts 02115, United States

University of Massachusetts Memorial Medical Center - University Campus, Worcester, Massachusetts 01655, United States

Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph, Saint Joseph, Michigan 49085, United States

University of Minnesota Cancer Center, Minneapolis, Minnesota 55455, United States

Veterans Affairs Medical Center - Minneapolis, Minneapolis, Minnesota 55417, United States

Ellis Fischel Cancer Center at University of Missouri - Columbia, Columbia, Missouri 65203, United States

Veterans Affairs Medical Center - Columbia (Truman Memorial), Columbia, Missouri 65201, United States

CCOP - Kansas City, Kansas City, Missouri 64131, United States

Missouri Baptist Cancer Center, Saint Louis, Missouri 63131, United States

Siteman Cancer Center, Saint Louis, Missouri 63110, United States

UNMC Eppley Cancer Center at the University of Nebraska Medical Center, Omaha, Nebraska 68198-7680, United States

CCOP - Southern Nevada Cancer Research Foundation, Las Vegas, Nevada 89106, United States

Veterans Affairs Medical Center - Las Vegas, Las Vegas, Nevada 89106, United States

New Hampshire Oncology-Hematology, PA - Hooksett, Hooksett, New Hampshire 03106, United States

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire 03756-0002, United States

Cooper University Hospital, Camden, New Jersey 08103, United States

Veterans Affairs Medical Center - Buffalo, Buffalo, New York 14215, United States

CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C., East Syracuse, New York 13057, United States

Queens Cancer Center of Queens Hospital, Jamaica, New York 11432, United States

CCOP - North Shore University Hospital, Manhasset, New York 11030, United States

North Shore University Hospital, Manhasset, New York 11030, United States

Memorial Sloan-Kettering Cancer Center, New York, New York 10021, United States

Mount Sinai Medical Center, New York, New York 10029, United States

New York Weill Cornell Cancer Center at Cornell University, New York, New York 10021, United States

University Hospital at State University of New York - Upstate Medical University, Syracuse, New York 13210, United States

Veterans Affairs Medical Center - Syracuse, Syracuse, New York 13210, United States

Veterans Affairs Medical Center - Asheville, Asheville, North Carolina 28805, United States

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill, North Carolina 27599-7295, United States

NorthEast Oncology Associates - Concord, Concord, North Carolina 28025, United States

Duke Comprehensive Cancer Center, Durham, North Carolina 27710, United States

Veterans Affairs Medical Center - Durham, Durham, North Carolina 27705, United States

Cape Fear Valley Health System, Fayetteville, North Carolina 28302-2000, United States

CCOP - Southeast Cancer Control Consortium, Goldsboro, North Carolina 27534-9479, United States

FirstHealth Moore Regional Hospital, Pinehurst, North Carolina 28374, United States

Zimmer Cancer Center at New Hanover Regional Medical Center, Wilmington, North Carolina 28402-9025, United States

Comprehensive Cancer Center at Wake Forest University, Winston-Salem, North Carolina 27157-1082, United States

Arthur G. James Cancer Hospital at Ohio State University, Columbus, Ohio 43210-1240, United States

Oklahoma University Medical Center, Oklahoma City, Oklahoma 73104, United States

Western Pennsylvania Hospital, Pittsburgh, Pennsylvania 15224, United States

Lifespan: The Miriam Hospital, Providence, Rhode Island 02906, United States

Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas, Dallas, Texas 75390-8852, United States

Veterans Affairs Medical Center - Dallas, Dallas, Texas 75219, United States

Vermont Cancer Center at University of Vermont, Burlington, Vermont 05401-3498, United States

Martha Jefferson Hospital, Charlottesville, Virginia 22902, United States

Virginia Oncology Associates - Norfolk, Norfolk, Virginia 23502, United States

MBCCOP - Massey Cancer Center, Richmond, Virginia 23298-0037, United States

Oncology and Hematology Associates of Southwest Virginia, Incorporated - Roanoke, Roanoke, Virginia 24014, United States

St. Mary's Medical Center, Huntington, West Virginia 25701, United States

Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: December 2003
Last updated: September 28, 2013

Page last updated: August 23, 2015

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