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Phase II Study of Second-Line Bendamustine in Relapsed or Refractory Small Cell Lung Cancer (SCLC).


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lung Cancer

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Trial Information

Phase II Study of Second-Line Bendamustine in Relapsed or Refractory Small Cell Lung Cancer (SCLC).


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.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed small cell lung cancer

- Relapsed or refractory disease after 1-2 prior chemotherapy regimens

- Measurable disease

- ECOG performance status 0-2

- ANC ≥ 1,500/mm³

- 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)

- 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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Median time to progression of disease

Outcome Time Frame:

at off-treatment, up to 18 weeks

Safety Issue:

No

Principal Investigator

Leora Horn, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Vanderbilt-Ingram Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

VICC THO 0920

NCT ID:

NCT00984542

Start Date:

September 2009

Completion Date:

January 2014

Related Keywords:

  • Lung Cancer
  • recurrent small cell lung cancer
  • Lung Neoplasms
  • Small Cell Lung Carcinoma

Name

Location
Vanderbilt-Ingram Cancer Center Nashville, Tennessee  37232-6838
Jackson-Madison County Hospital Jackson, Tennessee  38301
Vanderbilt-Ingram Cancer Center - Cool Springs Nashville, Tennessee  37064
Baptist Regional Cancer Center at Baptist Riverside Knoxville, Tennessee  37901
The Jones Clinic - Germantown Germantown, Tennessee  38138
Hardin Memorial Hosptial Elizabethtown, Kentucky  42701