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

Vanderbilt University Medical Center

Status and phase

Completed

Phase 2

Conditions

Lung Cancer

Treatments

Drug: bendamustine hydrochloride

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00984542

VICC THO 0920

P30CA068485 (U.S. NIH Grant/Contract)

VU-VICC-THO-0920

Details and patient eligibility

About

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.

Full 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 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.

Enrollment

50 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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