Combination Chemotherapy With or Without Filgrastim in Treating Patients With Previously Untreated Extensive-Stage Small Cell Lung Cancer
NCT ID: NCT00028925
Last Updated: 2016-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
27 participants
INTERVENTIONAL
2001-11-30
2008-08-31
Brief Summary
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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.
Detailed Description
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* Determine the tolerability of topotecan and carboplatin with or without filgrastim (G-CSF) in patients with extensive stage small cell lung cancer.
* Determine response and survival rates in patients treated with these regimens.
OUTLINE: This is a multicenter study. The first 12 patients are assigned to 1 of 2 treatment regimens (6 per regimen). The next 33 patients receive treatment based on the toxicity experienced by the first 12.
Regimen A:
* Patients receive oral topotecan once daily on days 1-5, carboplatin IV over 30 minutes on day 5, and filgrastim (G-CSF) subcutaneously once daily beginning on day 6 or 7 and continuing for up to 10 days or until blood counts recover.
* Patients are evaluated after the first 3-week course of chemotherapy. If no patient experiences unacceptable toxicity or febrile neutropenia, or no more than 1 patient experiences an absolute neutrophil count of less than 500/mm3 for more than 5 days, the next 6 patients begin treatment on regimen B. Otherwise, all patients receive treatment as in regimen A.
Regimen B:
* Patients receive topotecan and carboplatin as in regimen A.
* Patients are evaluated after the first 3-week course of chemotherapy. If no patient experiences unacceptable toxicity or febrile neutropenia, the next 33 patients receive treatment as in regimen B; otherwise, patients receive treatment as in regimen A.
Treatment for all patients repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with disease progression limited to CNS only interrupt chemotherapy to have whole-brain radiotherapy (WBRT). Once WBRT is complete, chemotherapy resumes.
Quality of life is assessed at baseline and at the beginning of each course of chemotherapy.
Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 49 patients will be accrued for this study within 13.5 months.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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Regimen A
Patients receive oral topotecan once daily on days 1-5, carboplatin IV over 30 minutes on day 5, and filgrastim (G-CSF) subcutaneously once daily beginning on day 6 or 7 and continuing for up to 10 days or until blood counts recover.
Treatment for all patients repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with disease progression limited to CNS only interrupt chemotherapy to have whole-brain radiotherapy (WBRT). Once WBRT is complete, chemotherapy resumes.
Quality of life is assessed at baseline and at the beginning of each course of chemotherapy.
Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
filgrastim
carboplatin
topotecan hydrochloride
WBRT
Regimen B
Patients receive topotecan and carboplatin as in regimen A. Patients are evaluated after the first 3-week course of chemotherapy. If no patient experiences unacceptable toxicity or febrile neutropenia, the next 33 patients receive treatment as in regimen B; otherwise, patients receive treatment as in regimen A.
Treatment for all patients repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with disease progression limited to CNS only interrupt chemotherapy to have whole-brain radiotherapy (WBRT). Once WBRT is complete, chemotherapy resumes.
Quality of life is assessed at baseline and at the beginning of each course of chemotherapy.
Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
filgrastim
carboplatin
topotecan hydrochloride
WBRT
Interventions
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filgrastim
carboplatin
topotecan hydrochloride
WBRT
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Alliance for Clinical Trials in Oncology
OTHER
Responsible Party
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Principal Investigators
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James R. Jett, MD
Role: STUDY_CHAIR
Mayo Clinic
Locations
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CCOP - Scottsdale Oncology Program
Scottsdale, Arizona, United States
MBCCOP-Howard University Cancer Center
Washington D.C., District of Columbia, United States
Mayo Clinic
Jacksonville, Florida, United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States
CCOP - Carle Cancer Center
Urbana, Illinois, United States
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States
Siouxland Hematology-Oncology
Sioux City, Iowa, United States
CCOP - Wichita
Wichita, Kansas, United States
Wichita Community Clinical Oncology Program
Wichita, Kansas, United States
CCOP - Ochsner
New Orleans, Louisiana, United States
CCOP - Ann Arbor Regional
Ann Arbor, Michigan, United States
CCOP - Duluth
Duluth, Minnesota, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
CentraCare Health Plaza
Saint Cloud, Minnesota, United States
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States
Medcenter One Health System
Bismarck, North Dakota, United States
CCOP - Merit Care Hospital
Fargo, North Dakota, United States
Altru Health Systems
Grand Forks, North Dakota, United States
CCOP - Toledo Community Hospital Oncology Program
Toledo, Ohio, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
Rapid City Regional Hospital
Rapid City, South Dakota, United States
Allan Blair Cancer Centre
Regina, Saskatchewan, Canada
Countries
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References
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Bryce AH, Mattar B, Hillman SL, Adjei AA, Kugler JW, Rowland K Jr, Wender DB, Soori G, Perez EA, Jett JR. Phase II trial of oral topotecan and intravenous carboplatin with G-CSF support in previously untreated patients with extensive stage small cell lung cancer: A North Central Cancer Treatment Group Study. Am J Clin Oncol. 2010 Aug;33(4):353-7. doi: 10.1097/COC.0b013e3181b0c27f.
Other Identifiers
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NCI-2012-02441
Identifier Type: REGISTRY
Identifier Source: secondary_id
CDR0000069147
Identifier Type: REGISTRY
Identifier Source: secondary_id
NCCTG-N0027
Identifier Type: -
Identifier Source: org_study_id