Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Combination Chemotherapy in Treating Patients With Advanced Non-Small Cell Lung Cancer

This study has been completed.
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: July 8, 2002
Last updated: June 6, 2009
Last verified: August 2002

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of carboplatin, gemcitabine, and exisulind in treating patients who have advanced non-small cell lung cancer.

Condition Intervention Phase
Lung Cancer
Drug: carboplatin
Drug: exisulind
Drug: gemcitabine hydrochloride
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase II Trial Of Carboplatin And Gemcitabine With Exisulind In Patients With Advanced Non-Small Cell Lung Cancer

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: August 2002
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
Detailed Description:


  • 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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00041314

  Show 79 Study Locations
Sponsors and Collaborators
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Study Chair: Gregory A. Masters, MD NorthShore University HealthSystem Research Institute
  More Information

Publications: Identifier: NCT00041314     History of Changes
Other Study ID Numbers: CDR0000069467  E-E1501 
Study First Received: July 8, 2002
Last Updated: June 6, 2009
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Sulindac sulfone
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anticarcinogenic Agents
Protective Agents
Cyclooxygenase Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents processed this record on October 26, 2016