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

Phase 2
18 Years
Not Enrolling
Lung Cancer

Thank you

Trial Information

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



- 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.


- 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.

Inclusion Criteria


- 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



- 18 and over

Performance status

- ECOG 0-2

Life expectancy

- Not specified


- Granulocyte count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3


- Bilirubin no greater than 1.5 mg/dL

- AST no greater than 2.0 times upper limit of normal


- Creatinine no greater than 1.5 mg/dL


- 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


- No pulmonary embolism within the past 6 months


- No history of gastrointestinal (GI) bleeding

- No history of peptic ulcer disease

- No active GI bleeding


- 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


Biologic therapy

- No prior immunotherapy for NSCLC


- 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


- See Disease Characteristics

- At least 2 weeks since prior radiotherapy and recovered


- See Disease Characteristics

- At least 2 weeks since prior surgery and recovered


- 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)

Type of Study:


Study Design:

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

Outcome Measure:

Disease free survival

Outcome Time Frame:

9 months

Safety Issue:


Principal Investigator

Martin J. Edelman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Maryland Greenebaum Cancer Center


United States: Federal Government

Study ID:




Start Date:

December 2003

Completion Date:

May 2011

Related Keywords:

  • Lung Cancer
  • 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
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



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Martha Jefferson HospitalCharlottesville, Virginia  22901
MBCCOP - University of Illinois at ChicagoChicago, Illinois  60612
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Ellis Fischel Cancer Center at University of Missouri - ColumbiaColumbia, Missouri  65203
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire  03756-0002
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel Hill, North Carolina  27599-7570
North Shore University HospitalManhasset, New York  11030
Veterans Affairs Medical Center - Chicago (Westside Hospital)Chicago, Illinois  60612
Naval Medical Center - San DiegoSan Diego, California  92134-3202
Veterans Affairs Medical Center - San FranciscoSan Francisco, California  94121
Baptist Hospital East - LouisvilleLouisville, Kentucky  40207
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.Syracuse, New York  13217
Veterans Affairs Medical Center - MinneapolisMinneapolis, Minnesota  55417
Veterans Affairs Medical Center - Columbia (Truman Memorial)Columbia, Missouri  65201
Veterans Affairs Medical Center - BuffaloBuffalo, New York  14215
Veterans Affairs Medical Center - SyracuseSyracuse, New York  13210
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Broward General Medical CenterFort Lauderdale, Florida  33316
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer InstituteBoston, Massachusetts  02115
University of Massachusetts Memorial Medical Center - University CampusWorcester, Massachusetts  01655
Northeast Alabama Regional Medical CenterAnniston, Alabama  36207
Veterans Affairs Medical Center - San DiegoSan Diego, California  92161
UCSF Comprehensive Cancer CenterSan Francisco, California  94115
Veterans Affairs Medical Center - Washington, DCWashington, District of Columbia  20422
Louis A. Weiss Memorial HospitalChicago, Illinois  60640
West Suburban Center for Cancer CareRiver Forest, Illinois  60305
Fort Wayne Medical Oncology and Hematology, IncorporatedFort Wayne, Indiana  46885-5099
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Cooper University HospitalCamden, New Jersey  08103
Queens Cancer Center of Queens HospitalJamaica, New York  11432
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FirstHealth Moore Regional HospitalPinehurst, North Carolina  28374
Lifespan: The Miriam HospitalProvidence, Rhode Island  02906
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Virginia Oncology Associates - NorfolkNorfolk, Virginia  23502
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Mount Sinai Medical CenterNew York, New York  10029
Vermont Cancer Center at University of VermontBurlington, Vermont  05405-0075
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Greenebaum Cancer Center at University of Maryland Medical CenterBaltimore, Maryland  21201
UNMC Eppley Cancer Center at the University of Nebraska Medical CenterOmaha, Nebraska  68198-7680
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Lakeland Cancer Care Center at Lakeland Hospital - St. JosephSaint Joseph, Michigan  49085
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