Carcinoma, Small CellPhase 2NCT00284154
Vinflunine in the Treatment of Patients With Relapsed Extensive Small Cell Lung Cancer
A Phase 2 study testing Vinflunine in people with Carcinoma, Small Cell and Lung Cancer, run by SCRI Development Innovations, LLC at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Small Cell, Lung Cancer
- What is being tested?
- Vinflunine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2006to Nov 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- CNS involvement
- Serious active infection or underlying medical condition
- Significant history of uncontrolled cardiac disease
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Oncology Hematology Care
Cincinnati, Ohio, 45242
Florida Cancer Specialists
Fort Myers, Florida, 33901
Tennessee Oncology, PLLC
Nashville, Tennessee, 37023
About this study
Official title: A Phase II Trial of 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.
Read the 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.
- Conditions
- Carcinoma, Small Cell, Lung Cancer
- Being tested
- Vinflunine
- Keywords
- Extensive stage, Relapsed
- Medical subject headings
- Carcinoma, Small Cell, Lung Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VinflunineDrug
Also called Javlor
320mg/m2 every 21 days as a 15-20 minute infusion
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Patients received vinflunine 320 mg/m2 every 21 days as a 15- to 20-minute infusion. Receives: Drug: Vinflunine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 months
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2006 (estimated)
- Study startJan 2006
- Primary completionMay 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, Small CellStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- SCRI Development Innovations, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- David R. Spigel, MD, Principal investigator, SCRI Development Innovations, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00284154
- Sponsor's protocol ID
- SCRI LUN 122
- Status last verified
- Feb 2013
- First submitted
- 27 Jan 2006
- Last updated
- 13 Mar 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 20521355
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of VInflunine in the Treatment of Patients With Relapsed Extensive Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00284154
- Acronym / sponsor ID
- SCRI LUN 122
- Conditions
- Carcinoma, Small Cell, Lung Cancer
- Keywords
- Extensive stage, Relapsed
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- SCRI Development Innovations, LLCUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- Jan 2006
- Primary completion
- May 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 31 Jan 2006 (estimated)
- Results
- Posted 13 Mar 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: VinfluninePatients received vinflunine 320 mg/m2 every 21 days as a 15- to 20-minute infusion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- CNS involvement
- Serious active infection or underlying medical condition
- Significant history of uncontrolled cardiac disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VinflunineAlso: Javlor320mg/m2 every 21 days as a 15-20 minute infusion | Drug | Intervention |
Primary outcome
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.
3 secondary outcomes
Duration of Response, the Length of Time, in Months, That Protocol Treatment Produced an Objective Improvement in Patients' 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
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
Time frame: 18 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20521355Spigel 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David R. Spigel, MD principal investigator
SCRI Development Innovations, LLC
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vinflunine in people with Carcinoma, Small Cell and Lung Cancer, run by SCRI Development Innovations, LLC at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Mar 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00284154, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2013.