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Comparison of Two Combination Chemotherapy Regimens in Treating Non-small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00006004
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : August 20, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Eastern Cooperative Oncology Group

Tracking Information
First Submitted Date  ICMJE July 5, 2000
First Posted Date  ICMJE January 27, 2003
Last Update Posted Date August 20, 2013
Study Start Date  ICMJE May 2000
Actual Primary Completion Date January 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
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 Comparison of Two Combination Chemotherapy Regimens in Treating Non-small Cell Lung Cancer
Official Title  ICMJE A Randomized Phase II Trial of Paclitaxel-Carboplatin or Gemicitabine-Cisplatin in ECOG Performance Status 2 Non-Small Cell Lung Cancer Patients
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. It is not yet known which combination chemotherapy regimen is more effective for treating non-small cell lung cancer.

PURPOSE: Randomized phase II trial to compare the effectiveness of two combination chemotherapy regimens in treating patients who have non-small cell lung cancer.

Detailed Description

OBJECTIVES:

  • Compare overall survival, response rate, and time to progression of patients with non-small cell lung cancer treated with paclitaxel and carboplatin versus gemcitabine and cisplatin.
  • Compare the toxicities of each of these 2 regimens in this patient population.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to weight loss in the past 6 months (less than 5% vs at least 5%) and disease stage (stage IIIB with pleural or pericardial effusion or pleural implants vs stage IV/recurrent). Patients are randomized to one of two treatment arms.

  • Arm I: Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 15-30 minutes on day 1.
  • Arm II: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 followed by cisplatin IV over 1 hour on day 1 only.

Treatment continues in both arms every 21 days for up to 6 courses in the absence of unacceptable toxicity or disease progression.

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

PROJECTED ACCRUAL: Approximately 40-90 patients (20-45 per arm) will be accrued for this study within 12 months.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Primary Purpose: Treatment
Condition  ICMJE Lung Cancer
Intervention  ICMJE
  • Drug: carboplatin
  • Drug: cisplatin
  • Drug: gemcitabine hydrochloride
  • Drug: paclitaxel
Study Arms  ICMJE Not Provided
Publications *

*   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
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date January 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed non-small cell lung carcinoma of any of the following subtypes:

    • Squamous cell
    • Adenocarcinoma
    • Large cell anaplastic
    • Bronchioalveolar
    • Non-small cell carcinoma not otherwise specified
  • No small cell anaplastic elements allowed
  • Must have:

    • Recurrent disease after prior radiotherapy or surgery OR
    • Stage IV disease with distant metastases OR
    • Stage IIIB disease presenting with pleural or pericardial effusion on CT or chest x-ray or pleural implants documented pathologically or on CT or chest x-ray
  • Bidimensionally measurable or evaluable disease
  • Brain metastases allowed provided clinically stable after treatment with surgery and/or radiotherapy

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 2

Life expectancy:

  • Not specified

Hematopoietic:

  • Absolute neutrophil count at least 1,500/mm3
  • Platelet count at least 100,000/mm3

Hepatic:

  • Bilirubin no greater than 1.5 mg/dL
  • SGOT no greater than 5 times upper limit of normal

Renal:

  • Creatinine no greater than 1.5 mg/dL OR
  • Creatinine clearance at least 60 mL/min

Cardiovascular:

  • No uncontrolled high blood pressure, unstable angina, or congestive heart failure
  • No myocardial infarction within the past 6 months
  • No serious ventricular arrhythmias requiring medication

Other:

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No other active malignancies requiring ongoing treatment
  • No uncontrolled serious active infections
  • No suspected hypersensitivity to agents that utilize Cremophor
  • No evidence of neuropathy grade 2 or greater by history or physical examination

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior chemotherapy for non-small cell lung cancer

Endocrine therapy:

  • Not specified

Radiotherapy:

  • See Disease Characteristics
  • No prior radiotherapy to only site of measurable or evaluable disease unless subsequent progression documented by physical exam, radiograph, or pathology
  • Recovered from prior radiotherapy
  • No concurrent radiotherapy except for whole brain radiation for developing brain metastases

Surgery:

  • See Disease Characteristics
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (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,   Peru,   Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00006004
Other Study ID Numbers  ICMJE CDR0000068012
E-1599
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: Corey J. Langer, MD Fox Chase Cancer Center
PRS Account Eastern Cooperative Oncology Group
Verification Date August 2013

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