Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information

Alternate Title

Combination Chemotherapy in Treating Patients With Small Cell Lung Cancer

Basic Trial Information

Objectives

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.

Entry Criteria

Disease Characteristics:

Histologically or cytologically proven small cell lung cancer
 Limited and extensive stage eligible

Measurable or evaluable disease required

No symptomatic cerebral metastases

Prior/Concurrent Therapy:

No prior treatment

Biologic:
 Not specified

Chemotherapy:
 Not specified

Endocrine:
 Not specified

Radiotherapy:
 Not specified

Surgery:
 Not specified

Patient Characteristics:

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

Expected Enrollment

A total of 240 patients will be accrued for this study within approximately 2 
years.

Outline

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

Vivianne Tjan-Heijnen, MD, Protocol chair		Ph: 31-24-361-111 Email: vtjan@onco.azn.nl

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