Bendamustine as Second-Line Therapy in Treating Patients With Relapsed or Refractory Small Cell Lung Cancer
NCT ID: NCT00984542
Last Updated: 2014-03-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
50 participants
INTERVENTIONAL
2009-09-30
2012-09-30
Brief Summary
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PURPOSE: This phase II trial is studying how well bendamustine works as second- or third-line therapy in treating patients with relapsed or refractory small cell lung cancer.
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Detailed Description
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Primary
* To determine the time to progression in patients with relapsed or refractory small cell lung cancer treated with second- or third-line bendamustine.
Secondary
* To determine the toxicity of this drug in these patients.
* To determine the response rate, progression-free survival, and overall survival of patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive bendamustine IV over 1 hour on days 1 and 2. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 6-8 weeks.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Bendamustine
bendamustine hydrochloride
Bendamustine 120 mg/m2 IV on days 1 and 2 of a 21-day treatment cycle
Interventions
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bendamustine hydrochloride
Bendamustine 120 mg/m2 IV on days 1 and 2 of a 21-day treatment cycle
Eligibility Criteria
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Inclusion Criteria
* Histologically or cytologically confirmed small cell lung cancer
* Relapsed or refractory disease after 1-2 prior chemotherapy regimens
* Measurable disease
* ECOG - Eastern Cooperative Oncology Group performance status 0-2
* ANC ≥ 1,500/mm³: ANC = Absolute neutrophil count
* Platelet count ≥ 100,000/mm³
* Hemoglobin ≥ 9 g/dL
* Bilirubin normal
* AST/ALT ≤ 2 times upper limit of normal (ULN) (≤ 5 times ULN in patients with hepatic metastases; AST/ALT = alanine transaminase (ALT) and aspartate aminotransferase (AST)
* Creatinine clearance \> 40 mL/min
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception before, during, and for ≥ 3 months after completion of study therapy
* No known hypersensitivity to bendamustine
* No other malignancy for which the patient has been treated within the past year except for nonmelanoma skin cancer or carcinoma in situ of the cervix
* No cardiac disease, including any of the following:
* Unstable angina pectoris
* Life-threatening cardiac arrhythmia
* Symptomatic congestive heart failure
* No uncontrolled infection
* No other concurrent chemotherapy, immunotherapy, or anti-tumor hormonal therapy
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Vanderbilt-Ingram Cancer Center
OTHER
Responsible Party
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Leora Horn, MD
Assistant Professor of Medicine; Assistant Director, Educator Development Program; Clinical Director, Thoracic Oncology Program; Medical Oncologist
Principal Investigators
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Leora Horn, M.D.
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt-Ingram Cancer Center
Locations
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Hardin Memorial Hosptial
Elizabethtown, Kentucky, United States
The Jones Clinic - Germantown
Germantown, Tennessee, United States
Jackson-Madison County Hospital
Jackson, Tennessee, United States
Baptist Regional Cancer Center at Baptist Riverside
Knoxville, Tennessee, United States
Vanderbilt-Ingram Cancer Center - Cool Springs
Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Countries
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Related Links
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Vanderbilt-Ingram Cancer Center, Find a Clinical Trial
Other Identifiers
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VU-VICC-THO-0920
Identifier Type: -
Identifier Source: secondary_id
VICC THO 0920
Identifier Type: -
Identifier Source: org_study_id
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