Back to resultsVinflunine in the Treatment of Patients With Relapsed Extensive Small Cell Lung Cancer
Primary Purpose
Carcinoma, Small Cell, Lung Cancer
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Vinflunine
Sponsored by
About this trial
This is an interventional treatment trial for Carcinoma, Small Cell focused on measuring Extensive stage, Relapsed
Eligibility Criteria
Inclusion Criteria: Small cell lung cancer with progression after one previous chemotherapy or chemotherapy/radiation therapy regimen Measurable or evaluable disease Able to perform activities of daily living with minimal assistance Adequate hematological, liver, and kidney function Must give written informed consent prior to entry Exclusion Criteria: CNS involvement Serious active infection or underlying medical condition Significant history of uncontrolled cardiac disease
Sites / Locations
- Florida Cancer Specialists
- Oncology Hematology Care
- Tennessee Oncology, PLLC
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention
Arm Description
Patients received vinflunine 320 mg/m2 every 21 days as a 15- to 20-minute infusion.
Outcomes
Primary Outcome Measures
Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment
Overall response rate is the percentage of patients with complete response or partial response per RECIST v.1 Criteria. Complete response (CR) = Disappearance of all target lesions, disappearance of all nontarget lesions for at least 4 weeks. Partial Response (PR) = At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameters. The final response criteria assigned represented the best response obtained during treatment.
Secondary Outcome Measures
Duration of Response, the Length of Time, in Months, That Protocol Treatment Produced an Objective Improvement in Patients' Disease
The Response Duration was calculated from time of initial measured response to date of first observation of progressive disease.
Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death
Overall survival was measured from the date of study entry until the date of death.
Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease
Progression free survival was defined as the interval between the start date of treatment and the date of occurrence of progressive disease or death.
Full Information
NCT ID
NCT00284154
First Posted
January 27, 2006
Last Updated
February 8, 2013
Sponsor
SCRI Development Innovations, LLC
Collaborators
Bristol-Myers Squibb
1. Study Identification
Unique Protocol Identification Number
NCT00284154
Brief Title
Vinflunine in the Treatment of Patients With Relapsed Extensive Small Cell Lung Cancer
Official Title
A Phase II Trial of VInflunine in the Treatment of Patients With Relapsed Extensive Small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
November 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SCRI Development Innovations, LLC
Collaborators
Bristol-Myers Squibb
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This clinical trial involves the administration of the chemotherapeutic medication vinflunine. Vinflunine is not approved by the FDA and is experimental in the treatment of extensive small cell lung cancer. The purpose of this research trial is to study the effectiveness of vinflunine in patients with relapsed extensive small cell lung cancer, evaluate the toxicity, and evaluate how long the response to this drug lasts.
Detailed Description
Eligible patients will receive vinflunine as a 15-20 minute intravenous (IV)infusion once every three weeks (21 days). This three week treatment period is called a cycle. Patients whose cancer has not grown or if it has decreased in size may receive up to 6 cycles of vinflunine. Evaluation will be conducted every other cycle.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Small Cell, Lung Cancer
Keywords
Extensive stage, Relapsed
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Patients received vinflunine 320 mg/m2 every 21 days as a 15- to 20-minute infusion.
Intervention Type
Drug
Intervention Name(s)
Vinflunine
Other Intervention Name(s)
Javlor
Intervention Description
320mg/m2 every 21 days as a 15-20 minute infusion
Primary Outcome Measure Information:
Title
Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment
Description
Overall response rate is the percentage of patients with complete response or partial response per RECIST v.1 Criteria. Complete response (CR) = Disappearance of all target lesions, disappearance of all nontarget lesions for at least 4 weeks. Partial Response (PR) = At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameters. The final response criteria assigned represented the best response obtained during treatment.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Duration of Response, the Length of Time, in Months, That Protocol Treatment Produced an Objective Improvement in Patients' Disease
Description
The Response Duration was calculated from time of initial measured response to date of first observation of progressive disease.
Time Frame
18 months
Title
Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death
Description
Overall survival was measured from the date of study entry until the date of death.
Time Frame
18 months
Title
Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease
Description
Progression free survival was defined as the interval between the start date of treatment and the date of occurrence of progressive disease or death.
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Small cell lung cancer with progression after one previous chemotherapy or chemotherapy/radiation therapy regimen
Measurable or evaluable disease
Able to perform activities of daily living with minimal assistance
Adequate hematological, liver, and kidney function
Must give written informed consent prior to entry
Exclusion Criteria:
CNS involvement
Serious active infection or underlying medical condition
Significant history of uncontrolled cardiac disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David R. Spigel, MD
Organizational Affiliation
SCRI Development Innovations, LLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Florida Cancer Specialists
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
Oncology Hematology Care
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Tennessee Oncology, PLLC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37023
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20521355
Citation
Spigel DR, Hainsworth JD, Lane CM, Clark B, Burris HA, Greco FA. Phase II trial of vinflunine in relapsed small cell lung cancer. J Thorac Oncol. 2010 Jun;5(6):874-8. doi: 10.1097/jto.0b013e3181d86b76.
Results Reference
result
Links:
URL
http://journals.lww.com/jto/pages/articleviewer.aspx?year=2010&issue=06000&article=00020&type=abstract
Description
Published article in the Journal of Thoracic Oncology
Learn more about this trial
Vinflunine in the Treatment of Patients With Relapsed Extensive Small Cell Lung Cancer
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