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

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ClinicalTrials.gov Identifier: NCT00041314
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : January 1, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Eastern Cooperative Oncology Group

Tracking Information
First Submitted Date  ICMJE July 8, 2002
First Posted Date  ICMJE January 27, 2003
Last Update Posted Date January 1, 2019
Actual Study Start Date  ICMJE August 2002
Actual Primary Completion Date July 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00041314 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Combination Chemotherapy in Treating Patients With Advanced Non-Small Cell Lung Cancer
Official Title  ICMJE A Phase II Trial Of Carboplatin And Gemcitabine With Exisulind In Patients With Advanced Non-Small Cell Lung Cancer
Brief Summary

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.

Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Primary Purpose: Treatment
Condition  ICMJE Lung Cancer
Intervention  ICMJE
  • Drug: carboplatin
  • Drug: exisulind
  • Drug: gemcitabine hydrochloride
Study Arms  ICMJE Not Provided
Publications * Masters GA, Li S, Dowlati A, Madajewicz S, Langer C, Schiller J, Johnson D. A phase II trial of carboplatin and gemcitabine with exisulind (IND #65,056) in patients with advanced non-small cell lung cancer: an Eastern Cooperative Oncology Group study (E1501). J Thorac Oncol. 2006 Sep;1(7):673-8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE June 15, 2007
Actual Primary Completion Date July 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 120 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Puerto Rico,   South Africa,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00041314
Other Study ID Numbers  ICMJE CDR0000069467
E-E1501
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Eastern Cooperative Oncology Group
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: Gregory A. Masters, MD NorthShore University HealthSystem
PRS Account Eastern Cooperative Oncology Group
Verification Date December 2018

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