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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier:
NCT00006004
First received: July 5, 2000
Last updated: August 16, 2013
Last verified: August 2013

July 5, 2000
August 16, 2013
May 2000
January 2005   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00006004 on ClinicalTrials.gov Archive Site
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Comparison of Two Combination Chemotherapy Regimens in Treating Non-small Cell Lung Cancer
A Randomized Phase II Trial of Paclitaxel-Carboplatin or Gemicitabine-Cisplatin in ECOG Performance Status 2 Non-Small Cell Lung Cancer Patients

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.

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.

Interventional
Phase 2
Allocation: Randomized
Primary Purpose: Treatment
Lung Cancer
  • Drug: carboplatin
  • Drug: cisplatin
  • Drug: gemcitabine hydrochloride
  • Drug: paclitaxel
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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January 2005   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Peru,   Puerto Rico,   Australia
 
NCT00006004
CDR0000068012, E-1599
Not Provided
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Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Study Chair: Corey J. Langer, MD Fox Chase Cancer Center
Eastern Cooperative Oncology Group
August 2013

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