Skip to main content
OpenTrials
Completed

NCT Number: NCT00284154

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Carcinoma, Small Cell Carcinoma Disease Attributes Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Florida Cancer Specialists, Fort Myers, Florida, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vinflunine

Drug

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

Other names: Javlor

Primary outcomes

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

    Time frame: 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 outcomes

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

    Time frame: 18 months

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

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

    Time frame: 18 months

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

  3. 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

SCRI Development Innovations, LLC

Other

Collaborators

  • Bristol-Myers Squibb

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Jan 31, 2006
Registry last updated
Mar 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.