Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	18 and over	NCI	CALGB-30203 NCT00070486

Objectives

Primary

1. 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

1. Compare the response rate, distribution of survival, and failure-free survival time of patients treated with these regimens.
2. Correlate CYFRA and serum vascular endothelial growth factor levels with response and survival of patients treated with these regimens.
3. Correlate cyclo-oxygenase-2 and 5-lipoxygenase expression with survival of patients treated with these regimens.

Entry 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

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)

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Granulocyte count at least 1,500/mm³
• Platelet count at least 100,000/mm³

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

Expected Enrollment

A total of 117 patients (39 per treatment arm) will be accrued for this study within 11-12 months.

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.

Edelman MJ, Watson D, Wang X, et al.: Eicosanoid modulation in advanced lung cancer: cyclooxygenase-2 expression is a positive predictive factor for celecoxib + chemotherapy--Cancer and Leukemia Group B Trial 30203. J Clin Oncol 26 (6): 848-55, 2008.[PUBMED Abstract]

Edelman, MJ, Watson DM, Wang X, et al.: Eicosanoid modulation in advanced non-small cell lung cancer (NSCLC): CALGB 30203. [Abstract] J Clin Oncol 24 (Suppl 18): A-7025, 370s, 2006.

Trial Contact Information

Trial Lead Organizations

Cancer and Leukemia Group B

Martin Edelman, MD, Protocol chair		Ph: 410-328-2703; 800-888-8823 Email: medelman@umm.edu

Registry Information
Official Title		Randomized Phase II Study of Eicosanoid Pathway Modulators and Cytotoxic Chemotherapy in Advanced Non-Small Cell Lung Cancer
Trial Start Date		2003-12-15
Trial Completion Date		2008-02-20
Registered in ClinicalTrials.gov		NCT00070486
Date Submitted to PDQ		2003-09-02
Information Last Verified		2004-07-22
NCI Grant/Contract Number		CA31946

Back to Top