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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
5
5 mcg/kg/day IV (intravenous) days 4-13 and days 25-34 for a total of 20 doses.
6 mg via subcutaneous injection days 46 and 67
Concurrent: 120 mg/m\^2, IV on days 1-3 and days 22-24. Adjuvant: 120 mg/m\^2, IV on days 43-45 and days 65-66.
Concurrent: 60 mg/m\^2, IV on days 1 and 22. Adjuvant: 60 mg/m\^2, IV on days 43 and 64.
A total of 61.2 Gy in 5 weeks: Once-daily 1.8 Gy fractions for 15 fractions over 3 weeks beginning on day 1 of chemotherapy, then twice-daily 1.8 Gy fractions for 10 fractions over 2 weeks.
University of Florida Shands Cancer Center
Gainesville, Florida, United States
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, United States
Lucille P. Markey Cancer Center at University of Kentucky
Lexington, Kentucky, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Northern Rockies Radiation Oncology Center
Billings, Montana, United States
Methodist Estabrook Cancer Center
Omaha, Nebraska, United States
McDowell Cancer Center at Akron General Medical Center
Akron, Ohio, United States
Summa Center for Cancer Care at Akron City Hospital
Akron, Ohio, United States
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
...and 4 more locations
Number of Patients With Grade 3-4 Febrile Neutropenia During Concurrent Chemoradiotherapy
Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE. No testing was done due to early study termination.
Time frame: From start of treatment to end of concurrent chemoradiation, for a maximum of 45 days
Number of Patients With Grade 3-4 Febrile Neutropenia During Adjuvant Chemoradiotherapy
Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE.
Time frame: From the start to the end of adjuvant chemotherapy, a maximum of 24 days
Number of Patients With Dose Modifications or Treatment Delays
Time frame: From start of treatment to end of treatment, for a maximum of 66 days
Number of Patients With Grade 3+ Esophagitis, Pneumonitis, and Other Non-hematological Adverse Events
Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE. No testing was done due to early study termination.
Time frame: From registration to last follow-up, a maximum of 32.9 months
Number of Patients With Grade 4 Thrombocytopenia
Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE.
Time frame: From registration to last follow-up, a maximum of 32.9 months
Overall Survival
Overall survival time is defined as time from registration/randomization to the date of death from any cause. Overall survival rates are estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. Due to early termination with few patients, only counts of events have been calculated.
Time frame: From registration to last follow-up, a maximum of 32.9 months
Progression-free Survival
Progression is defined as any failure per Response Evaluation Criteria in Solid Tumors (RECIST) 1.0. Progression-free survival time is defined as time from registration to the date of first progression, death, or last known follow-up (censored). Progression-free survival rates are estimated using the Kaplan-Meier method. Due to early termination with few patients, only counts of events have been calculated.
Time frame: From registration to last follow-up, a maximum of 32.9 months
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