Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Leora Horn, MD, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier:
NCT00984542
First received: September 24, 2009
Last updated: January 23, 2014
Last verified: August 2013

September 24, 2009
January 23, 2014
September 2009
September 2012   (final data collection date for primary outcome measure)
Time to Progression [ 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) ] [ Designated as safety issue: No ]
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.
Median time to progression [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00984542 on ClinicalTrials.gov Archive Site
  • Number of Patients With Each Worst-grade Toxicity [ Time Frame: Day 1 of each 21-day cycle for 6 cycles and at 30 days after end of treatment, at 156 days ] [ Designated as safety issue: Yes ]
    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.
  • Best Response [ 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) ] [ Designated as safety issue: No ]

    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.

  • Progression-free Survival [ Time Frame: 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) ] [ Designated as safety issue: No ]
    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.
  • Overall Survival [ Time Frame: 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 ] [ Designated as safety issue: No ]
    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)
  • Toxicity [ Designated as safety issue: Yes ]
  • Response rate [ Designated as safety issue: No ]
  • Progression-free survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Bendamustine as Second-Line Therapy in Treating Patients With Relapsed or Refractory Small Cell Lung Cancer
Phase II Study of Second-Line Bendamustine in Relapsed or Refractory Small Cell Lung Cancer (SCLC).

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.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Lung Cancer
Drug: bendamustine hydrochloride
Bendamustine 120 mg/m2 IV on days 1 and 2 of a 21-day treatment cycle
Experimental: Bendamustine
Intervention: Drug: bendamustine hydrochloride
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
September 2012
September 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00984542
VICC THO 0920, P30CA068485, VU-VICC-THO-0920
Yes
Leora Horn, MD, Vanderbilt-Ingram Cancer Center
Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Leora Horn, M.D. Vanderbilt-Ingram Cancer Center
Vanderbilt-Ingram Cancer Center
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP