Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000574000 | |||
| NCI-2009-00742 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Cancer and Leukemia Group B | NETWORK |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
OBJECTIVES:
Primary
Secondary
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combined Modality Therapy with Growth Factor Support | Experimental | Concurrent radiation therapy, cisplatin, etoposide, and filgrastim followed by adjuvant cisplatin, etoposide, and pegfilgrastim. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Filgrastim | Drug | 5 mcg/kg/day IV (intravenous) days 4-13 and days 25-34 for a total of 20 doses. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Grade 3-4 Febrile Neutropenia During Adjuvant 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. |
Not provided
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed small cell carcinoma of the lung
Limited stage disease, defined as any of the following:
No complete tumor resection
Measurable or evaluable disease
Pleural effusion allowed provided the following conditions are present:
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:
No prior allergic reaction to the study drugs
PRIOR CONCURRENT THERAPY:
No prior systemic chemotherapy for lung cancer
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida Shands Cancer Center | Gainesville | Florida | 32610-0232 | United States | ||
| CCOP - Mount Sinai Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20421820 | Background | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Combined Modality Therapy With Growth Factor Support | Concurrent radiation therapy, cisplatin, etoposide, and filgrastim followed by adjuvant cisplatin, etoposide, and pegfilgrastim. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Pegfilgrastim | Drug | 6 mg via subcutaneous injection days 46 and 67 |
|
| 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. |
|
| Cisplatin | 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 | 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. |
|
| 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 | 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 registration to last follow-up, a maximum of 32.9 months |
| Number of Patients With Grade 4 Thrombocytopenia | 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. | From registration to last follow-up, a maximum of 32.9 months |
| Overall Survival | Overall survival time is defined as time from registration/randomization to the date of death from any cause. Overall survival rates are estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. Due to early termination with few patients, only counts of events have been calculated. | From registration to last follow-up, a maximum of 32.9 months |
| Progression-free Survival | Progression is defined as any failure per Response Evaluation Criteria in Solid Tumors (RECIST) 1.0. Progression-free survival time is defined as time from registration to the date of first progression, death, or last known follow-up (censored). Progression-free survival rates are estimated using the Kaplan-Meier method. Due to early termination with few patients, only counts of events have been calculated. | From registration to last follow-up, a maximum of 32.9 months |
| Miami Beach |
| Florida |
| 33140 |
| United States |
| Lucille P. Markey Cancer Center at University of Kentucky | Lexington | Kentucky | 40536-0093 | United States |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland | 21231-2410 | United States |
| Northern Rockies Radiation Oncology Center | Billings | Montana | 59101 | United States |
| Methodist Estabrook Cancer Center | Omaha | Nebraska | 68114 | United States |
| McDowell Cancer Center at Akron General Medical Center | Akron | Ohio | 44307 | United States |
| Summa Center for Cancer Care at Akron City Hospital | Akron | Ohio | 44309-2090 | United States |
| Charles M. Barrett Cancer Center at University Hospital | Cincinnati | Ohio | 45267 | United States |
| Cleveland Clinic Taussig Cancer Center | Cleveland | Ohio | 44195 | United States |
| Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford | Salem | Ohio | 44460 | United States |
| Cancer Treatment Center | Wooster | Ohio | 44691 | United States |
| McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center | Reading | Pennsylvania | 19612-6052 | United States |
| Veterans Affairs Medical Center - Milwaukee | Milwaukee | Wisconsin | 53295 | United States |
| COMPLETED | Subjects contributing any data to results are considered to have completed the study |
|
| NOT COMPLETED |
|
All eligible patients.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Combined Modality Therapy With Growth Factor Support | Concurrent radiation therapy, cisplatin, etoposide, and filgrastim followed by adjuvant cisplatin, etoposide, and pegfilgrastim. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All registered patients | Posted | Count of Participants | Participants | From start of treatment to end of concurrent chemoradiation, for a maximum of 45 days |
|
|
| ||||||||||||||||||||||||||
| Secondary | Number of Patients With Grade 3-4 Febrile Neutropenia During Adjuvant 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. | All registered patients | Posted | Count of Participants | Participants | From the start to the end of adjuvant chemotherapy, a maximum of 24 days |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Patients With Dose Modifications or Treatment Delays | All registered patients | Posted | Count of Participants | Participants | From start of treatment to end of treatment, for a maximum of 66 days |
|
| ||||||||||||||||||||||||||||
| Secondary | Number of Patients With Grade 3+ Esophagitis, Pneumonitis, and Other Non-hematological Adverse Events | 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. | All registered patients | Posted | Count of Participants | Participants | From registration to last follow-up, a maximum of 32.9 months |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Patients With Grade 4 Thrombocytopenia | 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. | All registered patients | Posted | Count of Participants | Participants | From registration to last follow-up, a maximum of 32.9 months |
|
| |||||||||||||||||||||||||||
| Secondary | Overall Survival | Overall survival time is defined as time from registration/randomization to the date of death from any cause. Overall survival rates are estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. Due to early termination with few patients, only counts of events have been calculated. | All registered patients | Posted | Count of Participants | Participants | From registration to last follow-up, a maximum of 32.9 months |
|
| |||||||||||||||||||||||||||
| Secondary | Progression-free Survival | Progression is defined as any failure per Response Evaluation Criteria in Solid Tumors (RECIST) 1.0. Progression-free survival time is defined as time from registration to the date of first progression, death, or last known follow-up (censored). Progression-free survival rates are estimated using the Kaplan-Meier method. Due to early termination with few patients, only counts of events have been calculated. | All registered patients | Posted | Count of Participants | Participants | From registration to last follow-up, a maximum of 32.9 months |
|
|
Not provided
Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Combined Modality Therapy With Growth Factor Support | Concurrent radiation therapy, cisplatin, etoposide, and filgrastim followed by adjuvant cisplatin, etoposide, and pegfilgrastim. | 2 | 5 | 5 | 5 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood disorder | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hemoglobin decreased | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Sepsis [with Grade 3-4 ANC] | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Neurological disorder NOS | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial flutter | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Esophagitis | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Salivary gland disorder | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Bronchitis [with Grade 3-4 ANC] | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Sepsis [with unknown ANC] | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
|
This study stopped accrual early due to unmet targeted accrual goals with 5 subjects accrued out of 44 planned
PI's are required to abide by the sponsor's publication guidelines which require review by coauthors and subsequent review and approval by the sponsor.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Wendy Seiferheld | NRG Onocology | wseiferheld@nrgonology.org |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069585 | Filgrastim |
| C455861 | pegfilgrastim |
| D005047 | Etoposide |
| D002945 | Cisplatin |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D016179 | Granulocyte Colony-Stimulating Factor |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D013812 | Therapeutics |
Not provided
Not provided
|
| Title | Denominators | Categories |
|---|
|
|
|
|
|