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

SCRI Development Innovations, LLC51 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Carcinoma, Small Cell Lung Cancer

Interventions

VinflunineDRUG

320mg/m2 every 21 days as a 15-20 minute infusion

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Florida Cancer Specialists

Fort Myers, Florida, United States

Oncology Hematology Care

Cincinnati, Ohio, United States

Tennessee Oncology, PLLC

Nashville, Tennessee, United States

Outcomes

Primary Outcomes

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.

Time frame: 18 months

Secondary Outcomes

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.

Time frame: 18 months

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.

Time frame: 18 months

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.

Time frame: 18 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.