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A Phase II Trial Of Carboplatin And Gemcitabine With Exisulind In Patients With Advanced Non-Small Cell Lung Cancer

Phase 2
18 Years
Not Enrolling
Lung Cancer

Thank you

Trial Information

A Phase II Trial Of Carboplatin And Gemcitabine With Exisulind In Patients With Advanced Non-Small Cell Lung Cancer


- Determine the 18-month survival rate in patients with advanced non-small cell lung
cancer treated with carboplatin, gemcitabine, and exisulind.

- Determine the feasibility and toxicity of this regimen in these patients.

- Determine the response rate, progression-free survival, and overall median survival of
patients treated with this regimen.

OUTLINE: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and carboplatin IV
over 30 minutes on day 1. Chemotherapy repeats every 21 days for up to 6 courses. Patients
also receive oral exisulind twice daily beginning on day 1 of course 1 and continuing until
disease progression or unacceptable toxicity occurs.

Patients are followed every 3 months for 2 years and then every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study within 6 months.

Inclusion Criteria


- Histologically confirmed non-small cell lung cancer (NSCLC)

- Unresectable stage IIIB (e.g., pleural effusion) not suitable for combined
modality therapy OR

- Stage IV

- Prior brain metastases are allowed provided the following are true:

- Patient completed radiotherapy and/or surgery at least 3 weeks prior to study

- Objective evidence of resolution or significant improvement of brain lesions
exists on follow-up CT scan or MRI

- Patient is neurologically improved or stable



- 18 and over

Performance status:

- ECOG 0-1

Life expectancy:

- Not specified


- Absolute granulocyte count at least 1,500/mm^3

- WBC at least 3,000/mm^3

- Hemoglobin at least 9 g/L

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


- Bilirubin no greater than 1.25 mg/dL

- SGOT no greater than 1.5 times upper limit of normal


- Creatinine no greater than 2.0 mg/dL OR

- Creatinine clearance at least 50 mL/min


- No prior uncontrolled cardiovascular disease

- No hospitalization for acute myocardial infarction, arrhythmia, or congestive heart
failure within the past 3 months


- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective nonhormonal contraception

- No serious active infection

- No dementia or active psychoses

- No other prior malignancy except nonmetastatic nonmelanoma skin cancer, carcinoma in
situ of the cervix, or cancer curatively treated with surgery or small-field
radiotherapy within the past 5 years


Biologic therapy:

- Not specified


- No prior chemotherapy

Endocrine therapy:

- Not specified


- See Disease Characteristics

- At least 3 weeks since prior radiotherapy


- See Disease Characteristics


- At least 1 month since prior investigational agents

- More than 7 days since prior aspirin, sulindac, cyclo-oxygenase-2 (COX-2) inhibitors,
or nonsteroidal anti-inflammatory drugs (except ibuprofen or naproxen)

- No concurrent sulindac or COX-2 inhibitors

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Gregory A. Masters, MD

Investigator Role:

Study Chair

Investigator Affiliation:

NorthShore University HealthSystem Research Institute


United States: Federal Government

Study ID:




Start Date:

August 2002

Completion Date:

Related Keywords:

  • Lung Cancer
  • recurrent non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



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CCOP - Ann Arbor Regional Ann Arbor, Michigan  48106
University of Minnesota Cancer Center Minneapolis, Minnesota  55455
Ireland Cancer Center Cleveland, Ohio  44106-5065
University of Pennsylvania Cancer Center Philadelphia, Pennsylvania  19104
Fox Chase Cancer Center Philadelphia, Pennsylvania  19111
Robert H. Lurie Comprehensive Cancer Center, Northwestern University Chicago, Illinois  60611
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University of Alabama at Birmingham Comprehensive Cancer Center Birmingham, Alabama  35294-3300
NYU School of Medicine's Kaplan Comprehensive Cancer Center New York, New York  10016
Medical College of Wisconsin Milwaukee, Wisconsin  53226
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Holden Comprehensive Cancer Center Iowa City, Iowa  52242-1009
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Cancer Institute of New Jersey New Brunswick, New Jersey  08901
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City of Hope Comprehensive Cancer Center Duarte, California  91010
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