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

NCT00554463 | Completed Phase 2 Results DMC

• 3 other identifiers: RTOG 0623CDR0000574000NCI-2009-00742
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 14

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.

Conditions

Lung Cancer

Keywords

limited stage small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• Number of Patients With Grade 3-4 Febrile Neutropenia During Concurrent Chemoradiotherapy

  Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE. No testing was done due to early study termination.

  From start of treatment to end of concurrent chemoradiation, for a maximum of 45 days

Secondary Outcomes (6)

• Number of Patients With Grade 3-4 Febrile Neutropenia During Adjuvant Chemoradiotherapy

  From the start to the end of adjuvant chemotherapy, a maximum of 24 days

• Number of Patients With Dose Modifications or Treatment Delays

  From start of treatment to end of treatment, for a maximum of 66 days

• Number of Patients With Grade 3+ Esophagitis, Pneumonitis, and Other Non-hematological Adverse Events

  From registration to last follow-up, a maximum of 32.9 months

• Number of Patients With Grade 4 Thrombocytopenia

  From registration to last follow-up, a maximum of 32.9 months

• Overall Survival

  From registration to last follow-up, a maximum of 32.9 months

Study Arms (1)

Combined Modality Therapy with Growth Factor Support

EXPERIMENTAL

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

Drug: Filgrastim; Drug: Pegfilgrastim; Drug: Etoposide; Drug: Cisplatin; Radiation: radiation therapy

Interventions

Filgrastim DRUG

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

Combined Modality Therapy with Growth Factor Support

Pegfilgrastim DRUG

6 mg via subcutaneous injection days 46 and 67

Combined Modality Therapy with Growth Factor Support

Etoposide 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.

Combined Modality Therapy with Growth Factor Support

Cisplatin DRUG

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

Combined Modality Therapy with Growth Factor Support

radiation therapy 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.

Combined Modality Therapy with Growth Factor Support

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Radiation Therapy Oncology Group: lead
• National Cancer Institute (NCI): collaborator
• Cancer and Leukemia Group B: collaborator

Study Sites (14)

University of Florida Shands Cancer Center

Gainesville, Florida, 32610-0232, United States

Location

CCOP - Mount Sinai Medical Center

Miami Beach, Florida, 33140, United States

Location

Lucille P. Markey Cancer Center at University of Kentucky

Lexington, Kentucky, 40536-0093, United States

Location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

Northern Rockies Radiation Oncology Center

Billings, Montana, 59101, United States

Location

Methodist Estabrook Cancer Center

Omaha, Nebraska, 68114, United States

Location

McDowell Cancer Center at Akron General Medical Center

Akron, Ohio, 44307, United States

Location

Summa Center for Cancer Care at Akron City Hospital

Akron, Ohio, 44309-2090, United States

Location

Charles M. Barrett Cancer Center at University Hospital

Cincinnati, Ohio, 45267, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

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

Salem, Ohio, 44460, United States

Location

Cancer Treatment Center

Wooster, Ohio, 44691, United States

Location

McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center

Reading, Pennsylvania, 19612-6052, United States

Location

Veterans Affairs Medical Center - Milwaukee

Milwaukee, Wisconsin, 53295, United States

Location

Related Publications (1)

• 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.

  PMID: 20421820 BACKGROUND

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Filgrastim; pegfilgrastim; Etoposide; Cisplatin; Radiotherapy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Therapeutics

Limitations and Caveats

This study stopped accrual early due to unmet targeted accrual goals with 5 subjects accrued out of 44 planned

Results Point of Contact

• Title: Wendy Seiferheld
• Organization: NRG Onocology

wseiferheld@nrgonology.org

Study Officials

• Rogerio C. Lilenbaum, MD

  Mount Sinai Comprehensive Cancer Center at Mount Sinai Medical Center

  PRINCIPAL INVESTIGATOR

• 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

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2007
• First Posted: November 7, 2007
• Study Start: January 1, 2008
• Primary Completion: August 1, 2011
• Study Completion: August 3, 2011
• Last Updated: May 29, 2019
• Results First Posted: September 29, 2014

Record last verified: 2019-05

Locations

US (14)