Phase III Randomized Study of Standard CDE (Cyclophosphamide, Doxorubicin, and Etoposide) vs Intensified CDE and Filgrastim (G-CSF) in Patients With Small Cell Lung Cancer
Combination Chemotherapy in Treating Patients With Small Cell Lung Cancer
Basic Trial Information
|Phase III||Treatment||Closed||18 to 69||EORTC-08923|
I. Assess survival of patients with small cell lung cancer treated with standard CDE (cyclophosphamide, doxorubicin, and etoposide) vs intensified CDE and filgrastim (G-CSF). II. Assess the effect of 100% dose intensity on response rate in these patients.
Histologically or cytologically proven small cell lung cancer Limited and extensive stage eligible Measurable or evaluable disease required No symptomatic cerebral metastases
No prior treatment Biologic: Not specified Chemotherapy: Not specified Endocrine: Not specified Radiotherapy: Not specified Surgery: Not specified
Age: 18 to 69 Performance status: ECOG 0 or 1 Hematopoietic: WBC at least 4,000/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 4 g/dL Hepatic: Bilirubin no greater than 2.0 mg/dL Renal: Creatinine no greater than 1.6 mg/dL Cardiovascular: No symptomatic cardiovascular disease within the past 3 months No uncontrolled hypertension Other: No history or evidence of hypersensitivity to study drugs No other contraindication to the study drugs No evidence of active infection No temperature of 38.3 C or greater No previous malignancy except nonmelanoma skin cancer or adequately treated carcinoma in situ of the cervix Mentally and geographically able to undergo treatment and follow-up
A total of 240 patients will be accrued for this study within approximately 2 years.
This is a randomized study. Patients are stratified by center, age (under 60 vs 60 and over), and extent of disease (limited vs extensive). Patients are randomized to one of two treatment arms. Arm I: Patients receive cyclophosphamide IV and doxorubicin IV on day 1 and etoposide IV over 30 minutes on days 1-3. Filgrastim (G-CSF) is administered subcutaneously on days 4-13. Treatment repeats every 2 weeks for 4 courses. Arm II: Patients receive cyclophosphamide, doxorubicin, and etoposide as in arm I. Treatment repeats every 3 weeks for 5 courses. Treatment in both arms continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 weeks for at least 2 years.
Timmer-Bonte JN, de Boo TM, Smit HJ, et al.: Prevention of chemotherapy-induced febrile neutropenia by prophylactic antibiotics plus or minus granulocyte colony-stimulating factor in small-cell lung cancer: a Dutch Randomized Phase III Study. J Clin Oncol 23 (31): 7974-84, 2005.[PUBMED Abstract]
Tjan-Heijnen VC, Caleo S, Postmus PE, et al.: Economic evaluation of antibiotic prophylaxis in small-cell lung cancer patients receiving chemotherapy: an EORTC double-blind placebo-controlled phase III study (08923). Ann Oncol 14 (2): 248-57, 2003.[PUBMED Abstract]
Ardizzoni A, Tjan-Heijnen VC, Postmus PE, et al.: Standard versus intensified chemotherapy with granulocyte colony-stimulating factor support in small-cell lung cancer: a prospective European Organization for Research and Treatment of Cancer-Lung Cancer Group Phase III Trial-08923. J Clin Oncol 20 (19): 3947-55, 2002.[PUBMED Abstract]
Trial Contact Information
Trial Lead Organizations
European Organization for Research and Treatment of Cancer
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.