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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00984542
• Other study ID #: VICC THO 0920
• Secondary ID: P30CA068485VU-VI
• Status: Completed
• Phase: Phase 2
• First received: September 24, 2009
• Last updated: January 23, 2014
• Start date: September 2009
• Est. completion date: September 2012

Study information

• Verified date: August 2013
• Source: Vanderbilt-Ingram Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Small Cell Lung Carcinoma

Intervention

Drug:
• bendamustine hydrochloride
Bendamustine 120 mg/m2 IV on days 1 and 2 of a 21-day treatment cycle

Locations

Country	Name	City	State
United States	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	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee
United States	Vanderbilt-Ingram Cancer Center - Cool Springs	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt-Ingram Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	On-study to date of progression, measured following cycle 2, 4, and 6 of a 21-day cycle for 6 cycles, (during 126 days)	No
Secondary	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.	Day 1 of each 21-day cycle for 6 cycles and at 30 days after end of treatment, at 156 days	Yes
Secondary	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.	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)	No
Secondary	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.	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)	No
Secondary	Overall Survival	Estimated probable duration of life from on-study date to date of death from any cause, using the Kaplan-Meier method with censoring (see analysis population description for additional details)	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	No

External Links

•   Vanderbilt-Ingram Cancer Center, Find a Clinical Trial