G-CSF and Pegfilgrastim in Treating Neutropenia in Patients Undergoing Radiation Therapy and Chemotherapy for Limited Stage Small Cell Lung Cancer
|ClinicalTrials.gov Identifier: NCT00554463|
Recruitment Status : Completed
First Posted : November 7, 2007
Results First Posted : September 29, 2014
Last Update Posted : November 6, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Biological: Filgrastim Biological: Pegfilgrastim Drug: Concurrent chemotherapy Drug: Adjuvant chemotherapy Radiation: radiation therapy||Phase 2|
- 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.
- 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.
OUTLINE: This is a multicenter study.
Patients undergo thoracic radiotherapy once daily on days 1-5 of weeks 1-3 and twice daily on days 1-5 of weeks 4 and 5 for a total of 16 fractions. Patients also receive concurrent chemotherapy comprising cisplatin IV on day 1 and etoposide IV on days 1-3. Chemotherapy repeats every 3 weeks for 2 courses. Patients receive filgrastim (G-CSF) subcutaneously (SC) on days 4-13 and 25-34.
After completion of chemoradiotherapy, patients receive adjuvant chemotherapy comprising cisplatin IV on day 1 and etoposide IV on days 2 and 3. Adjuvant therapy repeats every 21 days for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients also receive pegfilgrastim SC on day 4 of each course of adjuvant therapy.
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 (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||A Phase II Trial of Combined Modality Therapy With Growth Factor Support for Patients With Limited Stage Small Cell Lung Cancer|
|Study Start Date :||January 2008|
|Actual Primary Completion Date :||August 2011|
U.S. FDA Resources
Experimental: Combined Modality Therapy with Growth Factor Support
Radiation therapy, concurrent chemotherapy and Filgrastim followed by adjuvant chemotherapy and Pegfilgrastim
5mcg/kg/day subcutaneously on days 4-13 and 25-34 after each concurrent chemotherapy cycle for a total of 20 doses.Biological: Pegfilgrastim
6 mg subcutaneously on day 4 of each adjuvant chemotherapy cycle.Drug: Concurrent chemotherapy
Drug: Adjuvant chemotherapy
Beginning day 1 of radiation threapy (+/- 24 hours), repeat cycle every 3 weeks for two cycles:
Day 1: Cisplatin, 60 mg/m^2 i.v.; Days 1-3: Etoposide, 120 mg/m^2 i.v.
Radiation: radiation therapy
Cycle 1: Day 43: Cisplatin, 60 mg/m^2 i.v. and Etoposide, 120 mg/m^2 i.v.; Days 44 & 45: Etoposide, 120 mg/m^2 i.v.
Cycle 2: Day 64: Cisplatin, 60 mg/m^2 i.v. and Etoposide, 120 mg/m^2; Days 65 & 66: Etoposide, 120 mg/m^2 i.v.
A total of 61.2 Gy in 5 weeks: 1.8 Gy daily x 5 week, for 3 weeks (days 1-16); 1.8 Gy, BID, in 4th week (days 17-20) with off cord boost in p.m.; Off-cord boost, 1.8 Gy BID, in 5th week (days 21-25).
- Incidence of Grade 4 Neutropenia or Grades 3-4 Febrile Neutropenia Episodes During Concurrent Chemoradiotherapy as Assessed by NCI CTCAE v 3.0 (Common Terminology Criteria for Adverse Events) [ Time Frame: At the completion of all treatment, approximately 80 days ]This study stopped accrual early with 5 accrued out of 44 planned, therefore no analyses were performed.
- Incidence of Grade 4 Neutropenia or Grades 3-4 Febrile Neutropenia Episodes During Adjuvant Chemotherapy as Assessed by NCI CTCAE v 3.0 [ Time Frame: At the completion of all treatment, approximately 80 days ]
- Incidence of Dose Modifications or Treatment Delays [ Time Frame: At the completion of all treatment, approximately 80 days ]
- Incidence of Esophagitis, Pneumonitis, and Other Non-hematological Adverse Events as Assessed by NCI CTCAE v 3.0 [ Time Frame: At the completion of all treatment, approximately 80 days ]
- Incidence of Grade 4 Thrombocytopenia [ Time Frame: At the completion of all treatment, approximately 80 days ]
- Median and 2-year Rates of Progression-free and Overall Survival [ Time Frame: After all patients have been potentially followed for 2 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00554463
|United States, Florida|
|University of Florida Shands Cancer Center|
|Gainesville, Florida, United States, 32610-0232|
|CCOP - Mount Sinai Medical Center|
|Miami Beach, Florida, United States, 33140|
|United States, Kentucky|
|Lucille P. Markey Cancer Center at University of Kentucky|
|Lexington, Kentucky, United States, 40536-0093|
|United States, Maryland|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|Baltimore, Maryland, United States, 21231-2410|
|United States, Montana|
|Northern Rockies Radiation Oncology Center|
|Billings, Montana, United States, 59101|
|United States, Nebraska|
|Methodist Estabrook Cancer Center|
|Omaha, Nebraska, United States, 68114|
|United States, Ohio|
|McDowell Cancer Center at Akron General Medical Center|
|Akron, Ohio, United States, 44307|
|Summa Center for Cancer Care at Akron City Hospital|
|Akron, Ohio, United States, 44309-2090|
|Charles M. Barrett Cancer Center at University Hospital|
|Cincinnati, Ohio, United States, 45267|
|Cleveland Clinic Taussig Cancer Center|
|Cleveland, Ohio, United States, 44195|
|Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford|
|Salem, Ohio, United States, 44460|
|Cancer Treatment Center|
|Wooster, Ohio, United States, 44691|
|United States, Pennsylvania|
|McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center|
|Reading, Pennsylvania, United States, 19612-6052|
|United States, Wisconsin|
|Veterans Affairs Medical Center - Milwaukee|
|Milwaukee, Wisconsin, United States, 53295|
|Principal Investigator:||Rogerio C. Lilenbaum, MD||Mount Sinai Comprehensive Cancer Center at Mount Sinai Medical Center|
|Study Chair:||Ritsuko U. Komaki, MD, FACR||M.D. Anderson Cancer Center|
|Study Chair:||Michael A. Samuels, MD||CCOP - Mount Sinai Medical Center|
|Study Chair:||Jeffrey Crawford, MD||Duke Cancer Institute|