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NCT00006004 · CITED IN SOURCE DOCUMENTS

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

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE2
Status at capture
COMPLETED
Registry last update
2023-06-15

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
eligibility Criteria
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
healthy Volunteers
false
maximum Age
120 Years
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
interventions
  1. name
    carboplatin
    type
    DRUG
  2. name
    cisplatin
    type
    DRUG
  3. name
    gemcitabine hydrochloride
    type
    DRUG
  4. name
    paclitaxel
    type
    DRUG
Study design
allocation
RANDOMIZED
primary Purpose
TREATMENT
EnrollmentSource null
Registered outcome plans (not posted results)
Full study description
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.
Source references
references
  1. citation
    Langer C, Li S, Schiller J, Tester W, Rapoport BL, Johnson DH; Eastern Cooperative Oncology Group. Randomized phase II trial of paclitaxel plus carboplatin or gemcitabine plus cisplatin in Eastern Cooperative Oncology Group performance status 2 non-small-cell lung cancer patients: ECOG 1599. J Clin Oncol. 2007 Feb 1;25(4):418-23. doi: 10.1200/JCO.2005.04.9452.
    pmid
    17264337
    type
    RESULT
  2. citation
    Tester WJ, Stephenson P, Langer CJ, et al.: ECOG 1599: randomized phase II study of paclitaxel/carboplatin or gemcitabine/cisplatin in performance status (PS) 2 patients with advanced non-small cell lung cancer (NSCLC). [Abstract] J Clin Oncol 22 (Suppl 14): A-7055, 630s, 2004.
    type
    RESULT
  3. citation
    Langer CJ, Stephenson P, Schiller J, et al.: ECOG 1599: randomized phase II study of paclitaxel/carboplatin vs cisplatin/gemcitabine in performance status (PS) 2 patients with treatment-naive advanced NSCLC. [Abstract] Lung Cancer 41 (Suppl 2): A-O52, S18, 2003.
    type
    RESULT
Source notices and limitations
    Discovery and provenance
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        l were substantially inferior to the patients with performance status of 0 to 1.</li></ul></div></li><li>A phase II randomized trial (<a href="/clinicaltrials/NCT00006004">E-1599</a> [NCT00006004]) of attenuated dosages of cisplatin plus gemcitabine and carboplatin plus paclitaxel included 102 patients with a performance status
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      2. context exact
        rior to the patients with performance status of 0 to 1.</li></ul></div></li><li>A phase II randomized trial (<a href="/clinicaltrials/NCT00006004">E-1599</a> [NCT00006004]) of attenuated dosages of cisplatin plus gemcitabine and carboplatin plus paclitaxel included 102 patients with a performance status of 2.[<a href="#cit/secti
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      source retrieved at
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      source title
      Non-Small Cell Lung Cancer Treatment (PDQ®)–Health Professional Version
      source update dates
      1. context
        Updated: May 15, 2025
        datetime
        2025-05-15T12:00:00Z
        display
        May 15, 2025

    Preserved source evidence · Not medical advice