Vinflunine in the Treatment of Patients With Relapsed Extensive Small Cell Lung Cancer

Lung Cancer Clinical Trial

Official title:

A Phase II Trial of VInflunine in the Treatment of Patients With Relapsed Extensive Small Cell Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00284154
• Other study ID #: SCRI LUN 122
• Status: Completed
• Phase: Phase 2
• First received: January 27, 2006
• Last updated: February 8, 2013
• Start date: January 2006
• Est. completion date: November 2009

Study information

• Verified date: February 2013
• Source: SCRI Development Innovations, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: November 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Small Cell
• Lung Cancer
• Lung Neoplasms
• Small Cell Lung Carcinoma

Intervention

Drug:
• Vinflunine
320mg/m2 every 21 days as a 15-20 minute infusion

Locations

Country	Name	City	State
United States	Oncology Hematology Care	Cincinnati	Ohio
United States	Florida Cancer Specialists	Fort Myers	Florida
United States	Tennessee Oncology, PLLC	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
SCRI Development Innovations, LLC	Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	18 months	No
Secondary	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.	18 months	No
Secondary	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.	18 months	No
Secondary	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.	18 months	No

External Links

•   Published article in the Journal of Thoracic Oncology