Phase III Study of Cyclophosphamide, Doxorubicin and Etoposide Compared to Carboplatin and Taxol in Patients With Extensive Disease Small Cell Lung Cancer
18 Years
N/A
Both
Lung Cancer
Trial Information
Phase III Study of Cyclophosphamide, Doxorubicin and Etoposide Compared to Carboplatin and Taxol in Patients With Extensive Disease 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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Outcome Measure:
Progression-free survival
Safety Issue:
No
Principal Investigator
Egbert F. Smit, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Free University Medical Center
Authority:
United States: Federal Government
Study ID:
CDR0000066803
NCT ID:
NCT00003696
Start Date:
October 1998
Completion Date:
Related Keywords:
- Lung Cancer
- extensive stage small cell lung cancer
- Lung Neoplasms
- Small Cell Lung Carcinoma
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