Phase 2 N=50 Treatment

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

Lung Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00984542 ↗

Enrolled (actual)

Serious AEs

54.0%

Results posted

Mar 2014

Primary outcome: Primary: Time to Progression — 123 days

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: bendamustine hydrochloride (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Vanderbilt-Ingram Cancer Center
Primary completion: Sep 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Time to Progression	123	—
SECONDARY Number of Patients With Each Worst-grade Toxicity	1; 14; 21; 5; 9	—
SECONDARY Best Response	1; 10; 14; 17	—
SECONDARY Progression-free Survival	98	—
SECONDARY Overall Survival	144	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00984542). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.