Status:
COMPLETED
Bendamustine as Second-Line Therapy in Treating Patients With Relapsed or Refractory Small Cell Lung Cancer
Lead Sponsor:
Vanderbilt-Ingram Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as bendamustine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This pha...
Detailed Description
OBJECTIVES: 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 ...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00984542
Start Date
September 1 2009
End Date
September 1 2012
Last Update
March 12 2014
Active Locations (6)
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1
Hardin Memorial Hosptial
Elizabethtown, Kentucky, United States, 42701
2
The Jones Clinic - Germantown
Germantown, Tennessee, United States, 38138
3
Jackson-Madison County Hospital
Jackson, Tennessee, United States, 38301
4
Baptist Regional Cancer Center at Baptist Riverside
Knoxville, Tennessee, United States, 37901