NCT00284154

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2006

Typical duration for phase_2

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

January 27, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 31, 2006

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
3.4 years until next milestone

Results Posted

Study results publicly available

March 13, 2013

Completed
Last Updated

March 13, 2013

Status Verified

February 1, 2013

Enrollment Period

3.3 years

First QC Date

January 27, 2006

Results QC Date

February 8, 2013

Last Update Submit

February 8, 2013

Conditions

Carcinoma, Small CellLung Cancer

Keywords

Extensive stageRelapsed

Outcome Measures

Primary Outcomes (1)

  • 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.

    18 months

Secondary Outcomes (3)

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

    18 months

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

    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

    18 months

Study Arms (1)

Intervention

EXPERIMENTAL

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

Drug: Vinflunine

Interventions

VinflunineDRUG

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

Also known as: Javlor
Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • CNS involvement
  • Serious active infection or underlying medical condition
  • Significant history of uncontrolled cardiac disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Florida Cancer Specialists

Fort Myers, Florida, 33901, United States

Location

Oncology Hematology Care

Cincinnati, Ohio, 45242, United States

Location

Tennessee Oncology, PLLC

Nashville, Tennessee, 37023, United States

Location

Related Publications (1)

  • Spigel DR, Hainsworth JD, Lane CM, Clark B, Burris HA, Greco FA. Phase II trial of vinflunine in relapsed small cell lung cancer. J Thorac Oncol. 2010 Jun;5(6):874-8. doi: 10.1097/jto.0b013e3181d86b76.

    PMID: 20521355RESULT

Related Links

MeSH Terms

Conditions

Carcinoma, Small CellLung NeoplasmsRecurrence

Interventions

vinflunine

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteLung DiseasesRespiratory Tract DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
John Hainsworth, MD
Organization
Sarah Cannon Research Institute
asksarah@scresearch.net
1-877-691-7274

Study Officials

  • David R. Spigel, MD

    SCRI Development Innovations, LLC

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2006

First Posted

January 31, 2006

Study Start

January 1, 2006

Primary Completion

May 1, 2009

Study Completion

November 1, 2009

Last Updated

March 13, 2013

Results First Posted

March 13, 2013

Record last verified: 2013-02

Locations

US(3)