Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Carcinoma

Small Cell Lung Carcinoma

Carcinoma, Small Cell

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Small Cell Lung Cancer

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

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

Vinflunine

David R. Spigel, MD

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.

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

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

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.

The Response Duration was calculated from time of initial measured response to date of first observation of progressive disease.

Overall survival was measured from the date of study entry until the date of death.

Progression free survival was defined as the interval between the start date of treatment and the date of occurrence of progressive disease or death.

Bristol-Myers Squibb

SCRI Development Innovations, LLC

Age, Categorical

Age Continuous

Sex: Female, Male

United States

Region of Enrollment

John Hainsworth, MD

Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment

All patients were assessed for response. Only patients with objective response were analyzed for response duration.

Duration of Response, the Length of Time, in Months, That Protocol Treatment Produced an Objective Improvement in Patients' Disease

All patients were assessed for overall survival.

Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death

All patients were assessed for progression free survival.

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

Spots Global Cancer Trial Database for Vinflunine in the Treatment of Patients With Relapsed Extensive Small Cell Lung Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial