Clinical trial NCT00984542: Bendamustine as Second-Line Therapy in Treating Patients With Relapsed or Refractory Small Cell Lung Cancer
Official title: Phase II Study of Second-Line Bendamustine in Relapsed or Refractory Small Cell Lung Cancer (SCLC).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lung Cancer
Keywords: recurrent small cell lung cancer
Lead sponsor: Vanderbilt-Ingram Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-09-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

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

Primary outcomes:
measure: Time to Progression
timeFrame: 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:
measure: Number of Patients With Each Worst-grade Toxicity
timeFrame: Day 1 of each 21-day cycle for 6 cycles and at 30 days after end of treatment, at 156 days
measure: Best Response
timeFrame: 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)
measure: Progression-free Survival
timeFrame: On-study date to lesser of date of progression or date of death from any cause ,measured following cycle 2, 4, 6 of a 21-day cycle for 6 cycles, (assessed up to 126 days)
measure: Overall Survival
timeFrame: On study to date of death from any cause or last date known alive, measured every 6-8 weeks from the end of treatment, up to 31 months
Other outcomes:
Locations:
city: Elizabethtown
country: United States
facility: Hardin Memorial Hosptial
state: Kentucky
city: Germantown
country: United States
facility: The Jones Clinic - Germantown
state: Tennessee
city: Jackson
country: United States
facility: Jackson-Madison County Hospital
state: Tennessee
city: Knoxville
country: United States
facility: Baptist Regional Cancer Center at Baptist Riverside
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center - Cool Springs
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
Study officials:
affiliation: Vanderbilt-Ingram Cancer Center
name: Leora Horn, M.D.
role: PRINCIPAL_INVESTIGATOR
References: