G-CSF and Pegfilgrastim in Treating Neutropenia in Patients Undergoing Radiation Therapy and Chemotherapy for Limited Stage Small Cell Lung Cancer
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Biological: filgrastim Biological: pegfilgrastim Drug: cisplatin Drug: etoposide Radiation: radiation therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: 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 |
- Incidence of grade 4 neutropenia or grades 3-4 febrile neutropenia episodes during concurrent chemoradiotherapy as assessed by NCI CTCAE v 3.0 [ Designated as safety issue: Yes ]
- Incidence of grade 4 neutropenia or grades 3-4 febrile neutropenia episodes during adjuvant chemotherapy as assessed by NCI CTCAE v 3.0 [ Designated as safety issue: Yes ]
- Incidence of dose modifications or treatment delays [ Designated as safety issue: Yes ]
- Incidence of esophagitis, pneumonitis, and other non-hematological adverse events as assessed by NCI CTCAE v 3.0 [ Designated as safety issue: Yes ]
- Incidence of grade 4 thrombocytopenia [ Designated as safety issue: Yes ]
- Median and 2-year rates of progression-free and overall survival [ Designated as safety issue: No ]
| Estimated Enrollment: | 44 |
| Study Start Date: | January 2008 |
| Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
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.
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 ≥ 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 or ALT ≤ 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)
- Creatinine ≤ 1.5 mg/dL
- Creatinine clearance ≥ 50 mL/min
- Must have best value of FEV1 ≥ 1.5 liters/second obtained on two measurements taken before and after use of a bronchodilator
- 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 < 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
- 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
Contacts and Locations| 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 | |
| Summa Center for Cancer Care at Akron City Hospital | |
| Akron, Ohio, United States, 44309-2090 | |
| McDowell Cancer Center at Akron General Medical Center | |
| Akron, Ohio, United States, 44307 | |
| 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 |
| Investigator: | Ritsuko U. Komaki, MD, FACR | M.D. Anderson Cancer Center |
| Study Chair: | Michael A. Samuels, MD | CCOP - Mount Sinai Medical Center |
| Investigator: | Jeffrey Crawford, MD | Duke Cancer Institute |
More Information
Additional Information:
Publications:
| Responsible Party: | Walter John Curran, Jr, Radiation Therapy Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00554463 History of Changes |
| Other Study ID Numbers: | CDR0000574000, RTOG-0623 |
| Study First Received: | November 6, 2007 |
| Last Updated: | December 13, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
limited stage small cell lung cancer |
Additional relevant MeSH terms:
|
Lung Neoplasms Small Cell Lung Carcinoma Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Cisplatin |
Etoposide Lenograstim Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antineoplastic Agents, Phytogenic Adjuvants, Immunologic Immunologic Factors |
ClinicalTrials.gov processed this record on May 16, 2013