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General Eligibility: |
Patients can be male or female, greater than or equal to 18 years of age and have confirmed limited stage non-small cell lung cancer. Subjects must have adequate hematologic, hepatic, renal, electrolyte, pulmonary function. |
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Purpose: |
Primary Objective:
To evaluate the safety and efficacy of filgrastim administered during concurrent chemoradiation (CT/RT) for limited stage small cell lung cancer (SCLC) in reducing grade 4 neutropenia or grades 3-4 febrile neutropenia
Secondary Objectives:
To evaluate the safety and efficacy of pegfilgrastim administered during adjuvant chemotherapy in reducing CTCAE, v. 3.0 grade 4 neutropenia or grades 3-4 febrile neutropenia; To estimate the incidence of dose modifications or treatment delays; To estimate the incidence of esophagitis, pneumonitis, and other non-hematological adverse events; To estimate the incidence of grade 4 thrombocytopenia; To estimate the median and two-year rate of progression-free survival (PFS) and overall survival (OS).
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Treatment: |
Radiation Therapy, Concurrent Chemotherapy and Filgrastim
Adjuvant Chemotherapy and Pegfilgrastim
Cycle 1:
Radiation Therapy: Total of 61.2 Gy in 5 weeks Day 43: Cisplatin, 60 mg/m2 and
1.8 Gy daily X 3 weeks (day 1-16) Etoposide, 120 mg/m2
1.8 Gy, BID, in 4th week (days 17-20) with off cord boost Days 44 & 45: Etoposide, 120 mg/m2
in p.m.
Cycle 2:
Chemotherapy: Two Cycles Day 64: Cisplatin, 60 mg/m2 and
beginning day 1 of RT (+/- 24 hours) Etoposide, 120 mg/m2
Day 1: Cisplatin, 60 mg/m2 Days 65 & 66: Etoposide, 120 mg/m2
Days 1-3: Etoposide, 120 mg/m2
Repeat cycle every 3 weeks X 2 cycles Pegfilgrastim: Day 4 of each adjuvant cycle
6 mg, total of 2 doses
Filgrastim: Days 4-13 and 25-34
5 mcg/kg/day, total of 20 doses PCI recommended for patients with CR (see section 6.10 of protocol)
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