Combination Chemotherapy With or Without Filgrastim in Treating Patients With Previously Untreated Extensive-Stage Small Cell Lung Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. PURPOSE: Phase II trial to compare the effectiveness of combination chemotherapy with or without filgrastim in treating patients who have extensive-stage small cell lung cancer that has not been previously treated.
Checked against the public recordLast updated Dec 7, 2016 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Alliance for Clinical Trials in Oncology
- Interventions being studied
- Biological: filgrastim; Drug: carboplatin; Drug: topotecan hydrochloride; Radiation: WBRT
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed extensive stage small cell lung cancer * Previously untreated with chemotherapy * No mixed histology * Metastatic disease outside the chest * Contralateral supraclavicular or hilar nodes that cannot be included in a single radiation port OR * Cytologically proven malignant pleural effusion * Measurable disease * No untreated CNS metastases * CNS metastases treated with whole-brain radiotherapy (WBRT) allowed after completion of WBRT PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * AST no greater than 5 times upper limit of normal (ULN) * Alkaline phosphatase no greater than 5 times ULN * Bilirubin no greater than 1.5 times ULN OR * Direct bilirubin no greater than ULN Renal: * Creatinine no greater than 1.5 times ULN OR * Creatinine clearance at least 50 mL/min Cardiovascular: * No uncontrolled angina pectoris * No congestive heart failure within the past 3 months unless ejection fraction is greater than 40% * No uncontrolled cardiac arrhythmias * No myocardial infarction within the past 3 months Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No clinically significant infection * No hypersensitivity to E. coli-derived proteins * No other malignancy within the past 3 years except non-melanoma skin cancer, carcinoma in situ of the cervix, or localized prostate cancer PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * See Disease Characteristics * At least 5 years since prior chemotherapy for another malignancy * No prior nitrosoureas Endocrine therapy: * Not specified Radiotherapy: * See Disease Characteristics * No prior thoracic radiotherapy * At least 1 day since prior palliative radiotherapy (except to chest) * No more than 3 fractions to chest for superior vena cava syndrome allowed * No concurrent radiotherapy (including thoracic radiotherapy) Surgery: * More than 3 weeks since prior major surgery
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- CCOP - Scottsdale Oncology ProgramScottsdale, Arizona
- MBCCOP-Howard University Cancer CenterWashington D.C., District of Columbia
- Mayo ClinicJacksonville, Florida
- CCOP - Illinois Oncology Research AssociationPeoria, Illinois
- CCOP - Carle Cancer CenterUrbana, Illinois
- CCOP - Cedar Rapids Oncology ProjectCedar Rapids, Iowa
- CCOP - Iowa Oncology Research AssociationDes Moines, Iowa
- Siouxland Hematology-OncologySioux City, Iowa
- CCOP - WichitaWichita, Kansas
- Wichita Community Clinical Oncology ProgramWichita, Kansas
- CCOP - OchsnerNew Orleans, Louisiana
- CCOP - Ann Arbor RegionalAnn Arbor, Michigan
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 7, 2016. Always confirm current availability with the study team.