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A Randomized Phase III Double Blind Trial Evaluating Selective COX-2 Inhibition in COX-2 Expressing Advanced Non-Small Cell Lung Cancer

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Trial Conditions
  • Lung Cancer
What is the purpose of this trial?

RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Pemetrexed disodium and celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving gemcitabine hydrochloride or pemetrexed disodium together with carboplatin is more effective with or without celecoxib in treating non-small cell lung cancer. PURPOSE: This randomized phase III trial is studying gemcitabine hydrochloride, pemetrexed disodium, and carboplatin to compare how well they work when given together with celecoxib or a placebo in treating patients with advanced non-small cell lung cancer.

Date & Status

Active, not recruiting

Who can Participate?


18 and older




- Histologically or cytologically confirmed non-small cell carcinoma of the lung,
including the following cell types:

- Adenocarcinoma

- Large cell carcinoma

- Squamous cell carcinoma

- Mixture of these types

- A tissue block must be available at the time of registration

- Tumor expresses COX-2 (COX-2 index ≥ 2)

- Stage IIIB disease with malignant pleural effusion, supraclavicular node involvement,
or contralateral hilar node involvement OR stage IV disease

- Patients with stage IIIB disease who are eligible for clinical trials that
involve combined chemotherapy and chest irradiation are not eligible for this

- Patients with stage IV disease are eligible

- Patients with recurrent disease, not amenable to (or refusing) a potentially
"curative therapy," are eligible

- Measurable or non-measurable disease

- Measurable disease is defined as lesions that can be accurately measured in ≥ 1
dimension (longest diameter to be recorded) as ≥ 2 cm with conventional
techniques or as ≥ 1 cm with spiral CT scan

- Non-measurable disease is defined as all other lesions, including small lesions
(longest diameter < 20 mm with conventional techniques or < 10 mm with spiral CT
scan) and truly nonmeasurable lesions, including any of the following:

- Bone lesions

- Leptomeningeal disease

- Ascites

- Pleural/pericardial effusion

- Inflammatory breast disease

- Lymphangitis cutis/pulmonis

- Abdominal masses that are not confirmed and followed by imaging techniques

- Cystic lesions

- Patients with symptomatic CNS metastases are eligible provided they received prior
therapy (e.g., surgery, radiotherapy, or gamma knife), are neurologically stable, and
are off steroids for ≥ 14 days before study entry

- Patients with asymptomatic CNS metastases without associated edema, shift, or
requirement for steroids or antiseizure medications may be eligible after
discussion with the Study Chair

- Patients should be off steroids at least 7 days before preregistration

- No leptomeningeal disease or carcinomatous meningitis


- ECOG performance status 0-2

- Granulocytes ≥ 1,500/μL

- Platelet count ≥ 100,000/μL

- Creatinine clearance ≥ 45 mL/min

- Bilirubin ≤ 1.5 mg/dL

- AST and ALT ≤ 2.0 times upper limit of normal (ULN) (≤ 5.0 times ULN if liver
metastases are present)

- Serum albumin ≥ 2.5 mg/dL

- Not pregnant or nursing

- Negative pregnancy test

- No "currently active" second malignancy other than non-melanoma 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 < 30% risk of

- No known hypersensitivity to aspirin, NSAIDs, or sulfonamides

- No active ulcer disease

- No history of gastrointestinal bleeding within the past three years

- None of the following cardiovascular conditions within the past 6 months:

- Myocardial infarction

- Unstable angina

- Symptomatic congestive heart failure

- Serious uncontrolled cardiac arrhythmia

- Cerebrovascular accident or transient ischemic attack

- Pulmonary embolism

- Symptomatic carotid artery or peripheral vascular disease

- Deep vein thrombosis

- Other significant thromboembolic event


- See Disease Characteristics

- No prior chemotherapy, immunotherapy, or other systemic therapy for non-small cell
lung cancer, including adjuvant therapy

- At least 2 weeks since prior surgery and recovered

- At least 7 days since prior radiotherapy

- At least 14 days since prior NSAIDs (other than low-dose aspirin [≤ 325 mg daily]),
including any of the following:

- Celecoxib

- Choline Mg

- Trisalicylate (Trilisate®)

- Ibuprofen (Advil® or Motrin®)

- Naproxen (Aleve®, Naprosyn® or Anaprox®)

- Etodolac (Lodine®)

- Oxaprozin (Daypro®)

- Diflunisal (Dolobid®)

- Nabumetone (Relafen®)

- Tolmetin (Tolectin®)

- Valdecoxib (Bextra®)

- No chronic use of NSAIDs (i.e., > 4 weeks of daily use)

- Patients on low-dose aspirin are eligible

- No other concurrent chemotherapy or hormonal therapy (other than megestrol acetate
[Megace] for appetite stimulation)

- No other concurrent investigational therapy

Gender: Both
Steward Physician(s)
  • Martin J. Edelman, MD
  • St. Elizabeth's Medical Center - Active, not recruiting
Trial Interventions
  • carboplatin
  • celecoxib
  • gemcitabine hydrochloride
  • pemetrexed disodium
  • placebo
For more information about this trial, contact

Uma Narayanasami

Phone: 617-789-3000

Physician Researcher

Investigator Name:

  • Martin J. Edelman, MD

Other Information

Sponsor: Alliance for Clinical Trials in Oncology
Phase: Phase 3
Trial ID: NCT01041781
Volunteers:  Not Accepting Healthy Volunteers

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