Topotecan, Paclitaxel, and 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 study the effectiveness of topotecan, paclitaxel, and filgrastim in treating patients who have previously untreated extensive-stage small cell lung cancer.
Checked against the public recordLast updated Jul 13, 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: paclitaxel; Drug: topotecan hydrochloride
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 previously untreated small cell lung cancer No mixed histology Extensive disease Metastatic disease outside the chest Contralateral supraclavicular nodes or contralateral hilar nodes outside a single radiation port OR Cytologically proven malignant pleural effusion Measurable or evaluable disease No untreated CNS metastases CNS metastases previously treated with whole brain radiotherapy allowed PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: AST no greater than 5 times upper limit of normal (ULN) Alkaline phosphatase no greater than 5 times ULN Total bilirubin no greater than 1.5 times ULN OR Direct bilirubin normal Renal: Creatinine no greater than 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 greater than 40% No uncontrolled arrhythmias No myocardial infarction within the past 3 months Other: No significant infection No hypersensitivity to E. coli derivatives No other malignancy within the past 3 years except nonmelanoma skin cancer, carcinoma in situ of the cervix, or localized prostate cancer Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 10 years since prior chemotherapy No prior nitrosourea based chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 10 years since prior thoracic radiotherapy No more than 3 fractions of prior thoracic radiotherapy for superior vena cava syndrome Prior palliative radiotherapy except to the chest allowed No prior radiotherapy to at least 20% bone marrow No concurrent radiotherapy (including thoracic), except whole brain radiotherapy for CNS progression Surgery: At least 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
- 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
- CCOP - DuluthDuluth, Minnesota
- Mayo Clinic Cancer CenterRochester, Minnesota
- CentraCare ClinicSaint Cloud, Minnesota
- CCOP - Metro-MinnesotaSaint Louis Park, Minnesota
- CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 13, 2016. Always confirm current availability with the study team.