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

Phase 2

Completed

• Conditions: Carcinoma, Small Cell; Lung Cancer
• Interventions: Drug: Vinflunine

• Registration Number: NCT00284154
• Lead Sponsor: SCRI Development Innovations, LLC

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.

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2006-01-27
• Study First Submitted QC: 2006-01-27
• Study First Posted: 2006-01-31
• Primary Completion: 2009-05
• Study Completion: 2009-11
• Status Verified: 2013-02
• Results First Submitted: 2013-02-08
• Results First Submitted QC: 2013-02-08
• Last Update Submitted: 2013-02-08
• Results First Posted: 2013-03-13
• Last Update Posted: 2013-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Vinflunine	Patients received vinflunine 320 mg/m2 every 21 days as a 15- to 20-minute infusion.

Primary Outcome Measures

Name	Time	Method
Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment	18 months	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

Name	Time	Method
Duration of Response, the Length of Time, in Months, That Protocol Treatment Produced an Objective Improvement in Patients' Disease	18 months	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	18 months	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	18 months	Progression free survival was defined as the interval between the start date of treatment and the date of occurrence of progressive disease or death.

Trial Locations

Locations (3)

Tennessee Oncology, PLLC; 🇺🇸 Nashville, Tennessee, United States

Florida Cancer Specialists; 🇺🇸 Fort Myers, Florida, United States

Oncology Hematology Care; 🇺🇸 Cincinnati, Ohio, United States