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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00041314
First received: July 8, 2002
Last updated: June 6, 2009
Last verified: August 2002

July 8, 2002
June 6, 2009
August 2002
July 2005   (final data collection date for primary outcome measure)
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Not Provided
Complete list of historical versions of study NCT00041314 on ClinicalTrials.gov Archive Site
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Combination Chemotherapy in Treating Patients With Advanced Non-Small Cell Lung Cancer
A Phase II Trial Of Carboplatin And Gemcitabine With Exisulind In Patients With Advanced Non-Small Cell Lung Cancer

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.

OBJECTIVES:

  • 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.

Interventional
Phase 2
Primary Purpose: Treatment
Lung Cancer
  • Drug: carboplatin
  • Drug: exisulind
  • Drug: gemcitabine hydrochloride
Not Provided
Masters GA, Xu R, Langer C, et al.: A phase II trial of carboplatin and gemcitabine with exisulind (IND # 65,056) in patients with advanced non-small cell lung cancer: Eastern Cooperative Oncology Group trial 1501. [Abstract] J Clin Oncol 22 (Suppl 14): A-7037, 626s, 2004.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
Not Provided
July 2005   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-1

Life expectancy:

  • Not specified

Hematopoietic:

  • 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

Hepatic:

  • Bilirubin no greater than 1.25 mg/dL
  • SGOT no greater than 1.5 times upper limit of normal

Renal:

  • Creatinine no greater than 2.0 mg/dL OR
  • Creatinine clearance at least 50 mL/min

Cardiovascular:

  • No prior uncontrolled cardiovascular disease
  • No hospitalization for acute myocardial infarction, arrhythmia, or congestive heart failure within the past 3 months

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • See Disease Characteristics
  • At least 3 weeks since prior radiotherapy

Surgery:

  • See Disease Characteristics

Other:

  • 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Puerto Rico,   South Africa
 
NCT00041314
CDR0000069467, E-E1501
Not Provided
Not Provided
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Study Chair: Gregory A. Masters, MD NorthShore University HealthSystem Research Institute
National Cancer Institute (NCI)
August 2002

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP