Phase II Study of Second-Line Bendamustine in Relapsed or Refractory Small Cell Lung Cancer (SCLC).
Phase II Study of Second-Line Bendamustine in Relapsed or Refractory Small Cell Lung Cancer (SCLC).
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 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.
OBJECTIVES:
Primary
Secondary
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.
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:
No uncontrolled infection
No other concurrent chemotherapy, immunotherapy, or anti-tumor hormonal therapy