Bendamustine as Second-Line Therapy in Treating Patients With Relapsed or Refractory Small Cell Lung Cancer

• Safety Profile Based on Number of Patients With Each Worst-grade Toxicity [ Time Frame: 30 days after completing treatment ] [ Designated as safety issue: Yes ]
• Response rate [ Time Frame: at off-treatment, up to 18 weeks ] [ Designated as safety issue: No ]
• Progression-free survival [ Time Frame: date on study to progression-free survival ] [ Designated as safety issue: No ]
• Overall survival rate [ Time Frame: date on study to date of death from any cause ] [ Designated as safety issue: No ]

• Toxicity [ Designated as safety issue: Yes ]
• Response rate [ Designated as safety issue: No ]
• Progression-free survival [ Designated as safety issue: No ]
• Overall survival [ Designated as safety issue: No ]

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

• 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.

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed small cell lung cancer
• Relapsed or refractory disease after 1-2 prior chemotherapy regimens
• Measurable disease
• ECOG performance status 0-2
• ANC ≥ 1,500/mm³
• 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)
• 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