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

• Status: Completed
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vanderbilt-Ingram Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Bendamustine Hydrochloride

Criteria

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