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

Vanderbilt-Ingram Cancer Center50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Lung Cancer

Interventions

bendamustine hydrochlorideDRUG

Bendamustine 120 mg/m2 IV on days 1 and 2 of a 21-day treatment cycle

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (6)

Hardin Memorial Hosptial

Elizabethtown, Kentucky, United States

The Jones Clinic - Germantown

Germantown, Tennessee, United States

Jackson-Madison County Hospital

Jackson, Tennessee, United States

Baptist Regional Cancer Center at Baptist Riverside

Knoxville, Tennessee, United States

Outcomes

Primary Outcomes

Time to Progression

Estimated probable duration from on-study date to date of disease progression, using the Kaplan-Meier method with censoring (see analysis population description for additional details). Disease progression is defined under RECIST v1.1 as \>=20% increase in sum of longest diameters of target lesions, unequivocal progression of non-target lesions, or appearance of new lesions.

Time frame: On-study to date of progression, measured following cycle 2, 4, and 6 of a 21-day cycle for 6 cycles, (during 126 days)

Secondary Outcomes

Number of Patients With Each Worst-grade Toxicity

Number of patients with worst-grade toxicity at each of five grades following NCI Common Toxicity Criteria with grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life-threatening/disabling, 5 = death.

Time frame: Day 1 of each 21-day cycle for 6 cycles and at 30 days after end of treatment, at 156 days

Best Response

Number of patients in each response category, per RECIST v1.1, summarized as follows for target lesion criteria (see RECIST v1.1 for additional details): complete response (CR),disappearance of target lesions; partial response (PR), \>=30% decrease in sum of longest diameter of target lesions; progressive disease (PD), \>=20% increase in sum of LD of target lesions or appearance of new lesions; stable disease (SD), insufficient change in target lesions or new lesions to qualify as either PD or SD. Patients are categorized according to the best response achieved prior to occurrence of progressive disease, where best response hierarchy is CR\>PR\>SD\>PD.

Time frame: On-treatment date to date of disease progression, following cycle 2, 4, and 6 of a 21-day cycle for 6 cycles, (assessed up to 126 days)

Progression-free Survival

Estimated probable duration of life without disease progression, from on-study date to earlier of progression date or date of death from any cause, using the Kaplan-Meier method with censoring (see analysis population description for additional details). Disease progression is defined under RECIST v1.1 as \>=20% increase in sum of longest diameters of target lesions, unequivocal progression of non-target lesions, or appearance of new lesions.

Data from ClinicalTrials.gov

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