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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00284154
Recruitment Status : Completed
First Posted : January 31, 2006
Results First Posted : March 13, 2013
Last Update Posted : March 13, 2013
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
SCRI Development Innovations, LLC

Study Description
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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.

Condition or disease Intervention/treatment Phase
Carcinoma, Small Cell Lung Cancer Drug: Vinflunine Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of VInflunine in the Treatment of Patients With Relapsed Extensive Small Cell Lung Cancer
Study Start Date : January 2006
Actual Primary Completion Date : May 2009
Actual Study Completion Date : November 2009

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Intervention
Patients received vinflunine 320 mg/m2 every 21 days as a 15- to 20-minute infusion.
 Drug: Vinflunine
320mg/m2 every 21 days as a 15-20 minute infusion
Other Name: Javlor


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00284154


Locations
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United States, Florida
Florida Cancer Specialists
Fort Myers, Florida, United States, 33901
United States, Ohio
Oncology Hematology Care
Cincinnati, Ohio, United States, 45242
United States, Tennessee
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37023
Sponsors and Collaborators
SCRI Development Innovations, LLC
Bristol-Myers Squibb
Investigators
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Principal Investigator: David R. Spigel, MD SCRI Development Innovations, LLC
More Information
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Additional Information:

Publications of Results:

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Responsible Party: SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier: NCT00284154    
Other Study ID Numbers: SCRI LUN 122
First Posted: January 31, 2006    Key Record Dates
Results First Posted: March 13, 2013
Last Update Posted: March 13, 2013
Last Verified: February 2013
Keywords provided by SCRI Development Innovations, LLC:
Extensive stage
Relapsed
Additional relevant MeSH terms:
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Lung Neoplasms
Small Cell Lung Carcinoma
Carcinoma, Small Cell
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
 Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type