Combination Chemotherapy in Treating Patients Who Have Extensive-Stage Small Cell Lung Cancer

Commissie Voor Klinisch Toegepast Onderzoek250 enrolled

Overview

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 most effective for extensive-stage small cell lung cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens in treating patients with extensive-stage small cell lung cancer.

OBJECTIVES: * Compare the effect of cyclophosphamide, doxorubicin, and etoposide with carboplatin and paclitaxel on progression free survival in patients with extensive stage small cell lung cancer. * Compare the overall survival, response rate, duration of response, and toxic effects of these regimens in these patients. OUTLINE: This is a randomized study. Patients are stratified according to institute and performance status (0-1 vs 2-3). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive cyclophosphamide IV and doxorubicin IV on day 1, and etoposide IV on days 1-3 every 3 weeks. * Arm II: Patients receive carboplatin IV followed by paclitaxel IV over 3 hours on day 1 every 3 weeks. Patients with stable or responding disease are treated for up to 5 courses. Patients are followed every 4 weeks. PROJECTED ACCRUAL: A total of 250 patients (125 per treatment arm) will be accrued within 24 months for this study.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Enrollment

250

Conditions

Lung Cancer

Interventions

carboplatinDRUG

cyclophosphamideDRUG

doxorubicin hydrochlorideDRUG

etoposideDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

DISEASE CHARACTERISTICS: * Histologically or cytologically proven extensive stage small cell lung cancer, not previously treated with chemotherapy or radiotherapy except for symptomatic brain metastases * Measurable or evaluable disease * Ascites, pleural effusions, osteolytic and osteoblastic bone metastases are not measurable or evaluable PATIENT CHARACTERISTICS: Age: * Over 18 Performance status: * ECOG 0-3 Life expectancy: * Not specified Hematopoietic: * Platelet count at least 100,000/mm\^3 * Absolute neutrophil count at least 2,000/mm\^3 Hepatic: * Bilirubin no greater than 1.25 times upper limit of normal (unless due to liver metastases) Renal: * Creatinine clearance at least 60 mL/min Cardiovascular: * No cardiac failure or rhythm disturbances requiring medication Other: * No history of hypersensitivity to castor oil * No active uncontrolled infection * No nonmalignant disease presenting a poor medical risk * Not pregnant * Fertile patients must use effective contraception during and for 3 months after the study PRIOR CONCURRENT THERAPY: Biologic therapy: * No concurrent immunotherapy Chemotherapy: * See Disease Characteristics * No other concurrent chemotherapy Endocrine therapy: * No concurrent hormonal therapy Radiotherapy: * See Disease Characteristics * Palliative radiotherapy allowed (indicator lesion should be outside of irradiated field) Surgery: * Not specified

Locations (1)

Vrije Universiteit Medisch Centrum

Amsterdam, Netherlands

Outcomes

Primary Outcomes

Progression-free survival

Secondary Outcomes

Overall survival

Response rate

Duration of response

Toxicity

Data from ClinicalTrials.gov

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