Comparing Cyclophosphamide, Doxorubicin, Etoposide versus Carboplatin and Paclitaxel in Extensive Stage Small Cell Lung Cancer
This study aims to compare the effectiveness of two treatment regimens, Cyclophosphosphamide, Doxorubicin, Etoposide and Carboplatin with Paclitaxel, in terms of progression-free survival in individuals with extensive stage small cell lung cancer.
carboplatin
+ cyclophosphamide
+ doxorubicin hydrochloride
Lung Diseases+4
+ Neoplasms
+ Neoplasms by Site
Treatment Study
Summary
Study start date: October 1, 1998
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.250 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Vrije Universiteit Medisch Centrum
Amsterdam, NetherlandsOpen Vrije Universiteit Medisch Centrum in Google Maps