Combination Chemotherapy With or Without Filgrastim in Treating Patients With Previously Untreated Extensive-Stage Small Cell Lung Cancer

• Status: Completed
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy.

PURPOSE: Phase II trial to compare the effectiveness of combination chemotherapy with or without filgrastim in treating patients who have extensive-stage small cell lung cancer that has not been previously treated.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alliance for Clinical Trials in Oncology
• Collaborator: National Cancer Institute (NCI)
• Treatments: Carboplatin; Lenograstim; Topotecan

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed extensive stage small cell lung cancer

• Previously untreated with chemotherapy

• No mixed histology

• Metastatic disease outside the chest

• Contralateral supraclavicular or hilar nodes that cannot be included in a single radiation port OR

• Cytologically proven malignant pleural effusion

• Measurable disease

• No untreated CNS metastases

• CNS metastases treated with whole-brain radiotherapy (WBRT) allowed after completion of WBRT

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

Hepatic:

• AST no greater than 5 times upper limit of normal (ULN)

• Alkaline phosphatase no greater than 5 times ULN

• Bilirubin no greater than 1.5 times ULN OR

• Direct bilirubin no greater than ULN

Renal:

• Creatinine no greater than 1.5 times ULN OR

• Creatinine clearance at least 50 mL/min

Cardiovascular:

• No uncontrolled angina pectoris

• No congestive heart failure within the past 3 months unless ejection fraction is greater than 40%

• No uncontrolled cardiac arrhythmias

• No myocardial infarction within the past 3 months

Other:

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No clinically significant infection

• No hypersensitivity to E. coli-derived proteins

• No other malignancy within the past 3 years except non-melanoma skin cancer, carcinoma in situ of the cervix, or localized prostate cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• See Disease Characteristics

• At least 5 years since prior chemotherapy for another malignancy

• No prior nitrosoureas

Endocrine therapy:

• Not specified

Radiotherapy:

• See Disease Characteristics

• No prior thoracic radiotherapy

• At least 1 day since prior palliative radiotherapy (except to chest)

• No more than 3 fractions to chest for superior vena cava syndrome allowed

• No concurrent radiotherapy (including thoracic radiotherapy)

Surgery:

• More than 3 weeks since prior major surgery