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

NCT ID: NCT00554463

Last Updated: 2019-05-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2011-08-03

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Combined Modality Therapy with Growth Factor Support

Concurrent radiation therapy, cisplatin, etoposide, and filgrastim followed by adjuvant cisplatin, etoposide, and pegfilgrastim.

Group Type: EXPERIMENTAL

Filgrastim

Intervention Type: DRUG

5 mcg/kg/day IV (intravenous) days 4-13 and days 25-34 for a total of 20 doses.

Pegfilgrastim

Intervention Type: DRUG

6 mg via subcutaneous injection days 46 and 67

Etoposide

Intervention Type: DRUG

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.

Cisplatin

Intervention Type: DRUG

Concurrent: 60 mg/m\^2, IV on days 1 and 22. Adjuvant: 60 mg/m\^2, IV on days 43 and 64.

radiation therapy

Intervention Type: RADIATION

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.

Interventions

Filgrastim

5 mcg/kg/day IV (intravenous) days 4-13 and days 25-34 for a total of 20 doses.

Intervention Type: DRUG

Pegfilgrastim

6 mg via subcutaneous injection days 46 and 67

Intervention Type: 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.

Intervention Type: DRUG

Cisplatin

Concurrent: 60 mg/m\^2, IV on days 1 and 22. Adjuvant: 60 mg/m\^2, IV on days 43 and 64.

Intervention Type: DRUG

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.

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

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 (absolute neutrophil count) ≥ 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 (aspartate aminotransferase) or ALT (alanine amino transferase ) ≤ 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)
• Serum creatinine ≤ 1.5 mg/dL
• Creatinine clearance ≥ 50 mL/min
• FEV1 (Forced Expiratory Volume) obtained pre- or post-bronchodilator must be ≥ 1.5 liters/second
• 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 (forced expiratory volume) < 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 (HIV testing not required for entry into this protocol)
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Cancer and Leukemia Group B

NETWORK

Sponsor Role: collaborator

Radiation Therapy Oncology Group

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rogerio C. Lilenbaum, MD

Role: PRINCIPAL_INVESTIGATOR

Mount Sinai Comprehensive Cancer Center at Mount Sinai Medical Center

Ritsuko U. Komaki, MD, FACR

Role: STUDY_CHAIR

M.D. Anderson Cancer Center

Michael A. Samuels, MD

Role: STUDY_CHAIR

CCOP - Mount Sinai Medical Center

Jeffrey Crawford, MD

Role: STUDY_CHAIR

Duke Cancer Institute

Locations

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

Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford

Salem, Ohio, United States

Cancer Treatment Center

Wooster, Ohio, United States

McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center

Reading, Pennsylvania, United States

Veterans Affairs Medical Center - Milwaukee

Milwaukee, Wisconsin, United States

Countries

United States

References

Lilenbaum R, Samuels M, Taffaro-Neskey M, Cusnir M, Pizzolato J, Blaustein A. Phase II trial of combined modality therapy with myeloid growth factor support in patients with locally advanced non-small cell lung cancer. J Thorac Oncol. 2010 Jun;5(6):837-40. doi: 10.1097/JTO.0b013e3181d6e141.

Reference Type: BACKGROUND

PMID: 20421820 (View on PubMed)

Other Identifiers

CDR0000574000

Identifier Type: -

Identifier Source: secondary_id

NCI-2009-00742

Identifier Type: REGISTRY

Identifier Source: secondary_id

RTOG 0623

Identifier Type: -

Identifier Source: org_study_id