Lung Cancer Clinical Trial

G-CSF and Pegfilgrastim in Treating Neutropenia in Patients Undergoing Radiation Therapy and Chemotherapy for Limited Stage Small Cell Lung Cancer

Summary

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.

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Full Description

OBJECTIVES:

Primary

To evaluate the safety and efficacy of filgrastim (G-CSF) in reducing grade 4 neutropenia or grades 3-4 febrile neutropenia in patients with limited stage small cell lung cancer treated with radiotherapy and concurrent chemotherapy comprising cisplatin and etoposide.

Secondary

To evaluate the safety and efficacy of pegfilgrastim in reducing grade 4 neutropenia or grades 3-4 febrile neutropenia in patients treated with adjuvant chemotherapy comprising cisplatin and etoposide.
To estimate the incidence of dose modifications or treatment delays in patients treated with this regimen.
To estimate the incidence of esophagitis, pneumonitis, and other non-hematological adverse events in patients treated with this regimen.
To estimate the incidence of grade 4 thrombocytopenia in patients treated with this regimen.
To estimate the median and two-year rate of progression-free and overall survival of patients treated with this regimen.

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.

View Eligibility Criteria

Eligibility Criteria

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed small cell carcinoma of the lung

Limited stage disease, defined as any of the following:

Tumor confined to one hemithorax
T4 tumor not based on malignant pleural effusion
N3 disease not based on contralateral supraclavicular involvement
No complete tumor resection
Measurable or evaluable disease

Pleural effusion allowed provided the following conditions are present:

Effusion is too small to tap under CT guidance and is not evident on chest x-ray
Effusion appears only after a thoracotomy or other invasive procedure
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:

Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months
Transmural myocardial infarction within the past 6 months
Acute bacterial or fungal infection requiring intravenous antibiotics
Chronic Obstructive Pulmonary Disease exacerbation with FEV1 (forced expiratory volume) < 1.5 liters/second or other respiratory illness requiring hospitalization or precluding study therapy within the past 30 days
Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
AIDS (HIV testing not required for entry into this protocol)
No prior allergic reaction to the study drugs

PRIOR CONCURRENT THERAPY:

No prior systemic chemotherapy for lung cancer

Prior chemotherapy for a different cancer is allowed, provided it was completed ≥ 5 years prior to registration
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

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

5

Study ID:

NCT00554463

Recruitment Status:

Completed

Sponsor:

Radiation Therapy Oncology Group

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There are 14 Locations for this study

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University of Florida Shands Cancer Center
Gainesville Florida, 32610, United States
CCOP - Mount Sinai Medical Center
Miami Beach Florida, 33140, United States
Lucille P. Markey Cancer Center at University of Kentucky
Lexington Kentucky, 40536, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore Maryland, 21231, United States
Northern Rockies Radiation Oncology Center
Billings Montana, 59101, United States
Methodist Estabrook Cancer Center
Omaha Nebraska, 68114, United States
McDowell Cancer Center at Akron General Medical Center
Akron Ohio, 44307, United States
Summa Center for Cancer Care at Akron City Hospital
Akron Ohio, 44309, United States
Charles M. Barrett Cancer Center at University Hospital
Cincinnati Ohio, 45267, United States
Cleveland Clinic Taussig Cancer Center
Cleveland Ohio, 44195, United States
Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford
Salem Ohio, 44460, United States
Cancer Treatment Center
Wooster Ohio, 44691, United States
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
Reading Pennsylvania, 19612, United States
Veterans Affairs Medical Center - Milwaukee
Milwaukee Wisconsin, 53295, United States

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

5

Study ID:

NCT00554463

Recruitment Status:

Completed

Sponsor:


Radiation Therapy Oncology Group

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