NCT00554463

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

A Phase II Trial of Combined Modality Therapy With Growth Factor Support for Patients With Limited Stage Small Cell Lung Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Radiation Therapy Oncology Group · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DRUG	Filgrastim	5 mcg/kg/day IV (intravenous) days 4-13 and days 25-34 for a total of 20 doses.
DRUG	Pegfilgrastim	6 mg via subcutaneous injection days 46 and 67
DRUG	Etoposide	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.
DRUG	Cisplatin	Concurrent: 60 mg/m\^2, IV on days 1 and 22. Adjuvant: 60 mg/m\^2, IV on days 43 and 64.
RADIATION	radiation therapy	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.

Timeline

• Start date: 2008-01-01
• Primary completion: 2011-08-01
• Completion: 2011-08-03
• First posted: 2007-11-07
• Last updated: 2019-05-29
• Results posted: 2014-09-29

Locations

14 sites across 1 country: United States