Combination Chemotherapy in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer

Fox Chase Cancer Center

Overview

RATIONALE: Drugs used in chemotherapy such as gemcitabine, carboplatin, and paclitaxel 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 chemotherapy regimen is more effective in treating non-small cell lung cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of different combination chemotherapy regimens in treating patients who have stage IIIB, stage IV, or recurrent non-small cell lung cancer.

OBJECTIVES: * Compare the overall survival of patients with stage IIIB or IV or recurrent non-small cell lung cancer treated with gemcitabine and carboplatin vs gemcitabine and paclitaxel vs paclitaxel and carboplatin. * Compare the overall response rate and time to progression in patients treated with these regimens. * Compare the toxic effects of these regimens in these patients. * Compare the quality of life of patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to weight loss within the past 6 months (less than 5% vs at least 5%), disease stage (IIIB vs IV), and brain metastases (present vs absent). Patients are randomized to 1 of 3 treatment arms. * Arm I: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and carboplatin IV over 15-30 minutes on day 1. * Arm II: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and paclitaxel IV over 3 hours on day 1. * Arm III: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 15-30 minutes on day 1. In all arms, treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, every 6 weeks during study treatment, and then every 3 months until progressive disease is documented. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 1,134 patients (378 per treatment arm) will be accrued for this study within 2 years.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Conditions

Lung Cancer

Interventions

carboplatinDRUG

gemcitabine hydrochlorideDRUG

paclitaxelDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

DISEASE CHARACTERISTICS: * Histologically confirmed non-small cell lung cancer (NSCLC) of 1 of the following types: * Squamous cell * Adenocarcinoma * Large cell anaplastic * Bronchoalveolar * Non-small cell carcinoma not otherwise specified NOTE: Mixed tumors are categorized by the predominant cell type (tumors with small-cell anaplastic elements are ineligible) * Evidence of at least 1 of the following: * Clinically documented recurrent disease after prior radiation or surgery * Stage IV disease (distant metastases) * Stage IIIB disease presenting with 1 of the following: * Pleural or pericardial effusion by CT scan or chest x-ray * Pleural implants documented pathologically or seen on CT scan or x-ray * Measurable or evaluable disease * No brain metastases unless clinically stable after surgery and/or radiotherapy PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-1 Life expectancy * Not specified Hematopoietic * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic * Bilirubin no greater than 1.5 mg/dL * AST less than 5 times upper limit of normal Renal * Creatinine no greater than 1.5 mg/dL OR * Creatinine clearance at least 40 mL/min Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No hypersensitivity to agents that contain Cremophor EL (polyoxyethylated castor oil) PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior chemotherapy for advanced NSCLC Endocrine therapy * Not specified Radiotherapy * See Disease Characteristics * Recovered from prior radiotherapy * No prior radiotherapy to the only site of measurable disease, unless the site had subsequent progression of disease documented by physical exam, radiography, or pathology * No concurrent radiotherapy (except for brain metastases) Surgery * See Disease Characteristics Other * No concurrent aminoglycoside antibiotics

Locations (57)

Outcomes

Primary Outcomes

Survival

Secondary Outcomes

Tumor response rate

Time to disease progression

Quality of life as measured by the Functional Assessment of Cancer -Lung (FACT-L) questionnaire at baseline, every 6 weeks during study treatment, and then every 3 months thereafter

Data from ClinicalTrials.gov

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