Vinflunine in the Treatment of Patients With Relapsed Extensive Small Cell Lung Cancer
This study has been completed.
Sponsor:
Sarah Cannon Research Institute
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Sarah Cannon Research Institute
ClinicalTrials.gov Identifier:
NCT00284154
First received: January 27, 2006
Last updated: February 8, 2013
Last verified: February 2013
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Carcinoma, Small Cell Lung Cancer |
Drug: Vinflunine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Sarah Cannon Research Institute:
Primary Outcome Measures:
- Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment [ Time Frame: 18 months ] [ Designated as safety issue: No ]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:
- Duration of Response, the Length of Time, in Months, That Protocol Treatment Produced an Objective Improvement in Patients' Disease [ Time Frame: 18 months ] [ Designated as safety issue: No ]The Response Duration was calculated from time of initial measured response to date of first observation of progressive disease.
- 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 ] [ Designated as safety issue: No ]Overall survival was measured from the date of study entry until the date of death.
- 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 ] [ Designated as safety issue: No ]Progression free survival was defined as the interval between the start date of treatment and the date of occurrence of progressive disease or death.
| Enrollment: | 51 |
| Study Start Date: | January 2006 |
| Study Completion Date: | November 2009 |
| Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00284154
Locations
| 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
Sarah Cannon Research Institute
Bristol-Myers Squibb
Investigators
| Principal Investigator: | David R. Spigel, MD | Sarah Cannon Research Institute |
More Information
Additional Information:
Publications:
| Responsible Party: | Sarah Cannon Research Institute |
| ClinicalTrials.gov Identifier: | NCT00284154 History of Changes |
| Other Study ID Numbers: | SCRI LUN 122 |
| Study First Received: | January 27, 2006 |
| Results First Received: | February 8, 2013 |
| Last Updated: | February 8, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Sarah Cannon Research Institute:
|
Extensive stage Relapsed |
Additional relevant MeSH terms:
|
Carcinoma Lung Neoplasms Small Cell Lung Carcinoma Carcinoma, Small Cell Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |
Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms |
ClinicalTrials.gov processed this record on May 21, 2013