Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
About
RATIONALE: Drugs used in chemotherapy, such as cisplatin and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Colony-stimulating factors, such as G-CSF or pegfilgrastim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy and radiation therapy.
PURPOSE: This phase II trial is studying G-CSF and pegfilgrastim to see how well they work in treating neutropenia in patients undergoing combination chemotherapy and radiation therapy for limited stage small cell lung cancer.
Full description
OBJECTIVES:
Primary
Secondary
After completion of study therapy, patients are followed every 3 months for one year, every 6 months for 2-3 years, and then annually for up to 5 years.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed small cell carcinoma of the lung
Limited stage disease, defined as any of the following:
No complete tumor resection
Measurable or evaluable disease
Pleural effusion allowed provided the following conditions are present:
Must have certification by a Radiation Oncologist that the tumor can be encompassed by limited radiotherapy fields without significantly compromising pulmonary function
No distant metastases
PATIENT CHARACTERISTICS:
Zubrod performance status 0-1
ANC (absolute neutrophil count) ≥ 1,800 cells/mm³
Platelet count ≥ 100,000 cells/mm³
Hemoglobin ≥ 10.0 g/dL (transfusion or other intervention to achieve hemoglobin ≥ 8.0 g/dL allowed)
Total bilirubin ≤ 1.5 mg/dL
AST (aspartate aminotransferase) or ALT (alanine amino transferase ) ≤ 2 times the upper limit of normal (ULN)
Alkaline phosphatase < 2.5 times ULN (< 5 times ULN if judged by the investigator to be related to liver metastases)
Serum creatinine ≤ 1.5 mg/dL
Creatinine clearance ≥ 50 mL/min
FEV1 (Forced Expiratory Volume) obtained pre- or post-bronchodilator must be ≥ 1.5 liters/second
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for ≥ 60 days after the last study treatment
No prior invasive malignancy, except non-melanomatous skin cancer or other micro-invasive malignancy, or carcinoma in situ of the breast, oral cavity, or cervix, unless the patient has been disease-free for a minimum of 3 years
No weight loss > 5% for any reason within the past 3 months
No severe, active comorbidity, defined as follows:
No prior allergic reaction to the study drugs
PRIOR CONCURRENT THERAPY:
No prior systemic chemotherapy for lung cancer
No prior radiotherapy to the region of the study cancer that would result in overlap of radiotherapy fields
No concurrent intensity-modulated radiotherapy
No concurrent amifostine
Primary purpose
Allocation
Interventional model
Masking
5 participants in 1 patient group
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal