Vinflunine in the Treatment of Patients With Relapsed Extensive Small Cell Lung Cancer
Study Details
Study Description
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 |
|---|---|---|
| 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
Arms and Interventions
| 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 Names:
|
Outcome Measures
Primary Outcome Measures
- Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment [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
- Duration of Response, the Length of Time, in Months, That Protocol Treatment Produced an Objective Improvement in Patients' Disease [18 months]
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 [18 months]
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 [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
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Florida Cancer Specialists | Fort Myers | Florida | United States | 33901 |
| 2 | Oncology Hematology Care | Cincinnati | Ohio | United States | 45242 |
| 3 | Tennessee Oncology, PLLC | Nashville | Tennessee | United States | 37023 |
Sponsors and Collaborators
- SCRI Development Innovations, LLC
- Bristol-Myers Squibb
Investigators
- Principal Investigator: David R. Spigel, MD, SCRI Development Innovations, LLC
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- SCRI LUN 122
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Vinflunine |
|---|---|
| Arm/Group Description | Patients received vinflunine 320 mg/m2 every 21 days as a 15- to 20-minute infusion. |
| Period Title: Overall Study | |
| STARTED | 51 |
| COMPLETED | 9 |
| NOT COMPLETED | 42 |
Baseline Characteristics
| Arm/Group Title | Vinflunine |
|---|---|
| Arm/Group Description | Patients received vinflunine 320 mg/m2 every 21 days as a 15- to 20-minute infusion. |
| Overall Participants | 51 |
| Age (Count of Participants) | |
| <=18 years |
0
0%
|
| Between 18 and 65 years |
33
64.7%
|
| >=65 years |
18
35.3%
|
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
61
(10.1)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
23
45.1%
|
| Male |
28
54.9%
|
| Region of Enrollment (participants) [Number] | |
| United States |
51
100%
|
Outcome Measures
| Title | Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment |
|---|---|
| Description | 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. |
| Time Frame | 18 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| All patients were assessed for response. |
| Arm/Group Title | Vinflunine |
|---|---|
| Arm/Group Description | Patients received vinflunine 320 mg/m2 every 21 days as a 15- to 20-minute infusion. |
| Measure Participants | 51 |
| Number (95% Confidence Interval) [percentage of participants] |
19.6
38.4%
|
| Title | Duration of Response, the Length of Time, in Months, That Protocol Treatment Produced an Objective Improvement in Patients' Disease |
|---|---|
| Description | The Response Duration was calculated from time of initial measured response to date of first observation of progressive disease. |
| Time Frame | 18 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| All patients were assessed for response. Only patients with objective response were analyzed for response duration. |
| Arm/Group Title | Vinflunine |
|---|---|
| Arm/Group Description | Patients received vinflunine 320 mg/m2 every 21 days as a 15- to 20-minute infusion. |
| Measure Participants | 10 |
| Median (95% Confidence Interval) [Months] |
2.7
|
| Title | Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death |
|---|---|
| Description | Overall survival was measured from the date of study entry until the date of death. |
| Time Frame | 18 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| All patients were assessed for overall survival. |
| Arm/Group Title | Vinflunine |
|---|---|
| Arm/Group Description | Patients received vinflunine 320 mg/m2 every 21 days as a 15- to 20-minute infusion. |
| Measure Participants | 51 |
| Median (95% Confidence Interval) [Months] |
4.9
|
| Title | 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 |
|---|---|
| Description | Progression free survival was defined as the interval between the start date of treatment and the date of occurrence of progressive disease or death. |
| Time Frame | 18 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| All patients were assessed for progression free survival. |
| Arm/Group Title | Vinflunine |
|---|---|
| Arm/Group Description | Patients received vinflunine 320 mg/m2 every 21 days as a 15- to 20-minute infusion. |
| Measure Participants | 51 |
| Median (95% Confidence Interval) [Months] |
1.6
|
Adverse Events
| Time Frame | ||
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Vinflunine | |
| Arm/Group Description | Patients received vinflunine 320 mg/m2 every 21 days as a 15- to 20-minute infusion. | |
All Cause Mortality |
||
| Vinflunine | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Vinflunine | ||
| Affected / at Risk (%) | # Events | |
| Total | 31/51 (60.8%) | |
| Blood and lymphatic system disorders | ||
| Hemoglobin | 2/51 (3.9%) | 2 |
| Neutrophils | 4/51 (7.8%) | 4 |
| Leukocytes | 2/51 (3.9%) | 2 |
| Platelets | 2/51 (3.9%) | 2 |
| Cardiac disorders | ||
| Supraventricular and nodal arrhythmia - Atrial Fibrillation | 1/51 (2%) | 1 |
| Endocrine disorders | ||
| Pancreatic endocrine: glucose intolerance | 1/51 (2%) | 1 |
| Gastrointestinal disorders | ||
| Constipation | 1/51 (2%) | 1 |
| Diarrhea | 1/51 (2%) | 1 |
| Dysphagia | 1/51 (2%) | 1 |
| Nausea | 1/51 (2%) | 1 |
| Obstruction, GI - Small Bowel NOS | 1/51 (2%) | 1 |
| Pain - abdomen | 2/51 (3.9%) | 2 |
| General disorders | ||
| Death not associated with CTCAE term - Disease Progression NOS | 11/51 (21.6%) | 11 |
| Failure to thrive | 1/51 (2%) | 1 |
| Fatigue | 1/51 (2%) | 1 |
| Pain - Other (Pain Syndrome) | 1/51 (2%) | 1 |
| Infections and infestations | ||
| Febrile Neutropenia | 2/51 (3.9%) | 2 |
| Infection - Other (Pneumonia) | 2/51 (3.9%) | 2 |
| Metabolism and nutrition disorders | ||
| Hyponatremia | 1/51 (2%) | 1 |
| Hyperglycemia | 1/51 (2%) | 1 |
| Musculoskeletal and connective tissue disorders | ||
| Pain - joint | 1/51 (2%) | 1 |
| Systemic lupus erythematosus | 1/51 (2%) | 1 |
| Nervous system disorders | ||
| Altered Mental Status | 1/51 (2%) | 1 |
| Neuropathy | 1/51 (2%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||
| Dyspnea | 1/51 (2%) | 1 |
| Pneumothorax | 1/51 (2%) | 1 |
Other (Not Including Serious) Adverse Events |
||
| Vinflunine | ||
| Affected / at Risk (%) | # Events | |
| Total | 30/51 (58.8%) | |
| Blood and lymphatic system disorders | ||
| Hemoglobin | 28/51 (54.9%) | 58 |
| Edema | 3/51 (5.9%) | 3 |
| Leukopenia | 15/51 (29.4%) | 30 |
| Neutropenia | 21/51 (41.2%) | 47 |
| Thrombocytopenia | 11/51 (21.6%) | 21 |
| Cardiac disorders | ||
| Hypertension | 3/51 (5.9%) | 5 |
| Gastrointestinal disorders | ||
| Anorexia | 16/51 (31.4%) | 30 |
| Constipation | 30/51 (58.8%) | 53 |
| Dehydration | 5/51 (9.8%) | 6 |
| Diarrhea | 12/51 (23.5%) | 15 |
| Mucositis | 4/51 (7.8%) | 11 |
| Nausea | 24/51 (47.1%) | 39 |
| Nausea (intermittent) | 4/51 (7.8%) | 7 |
| Pain (abdominal) | 6/51 (11.8%) | 6 |
| Vomiting | 16/51 (31.4%) | 23 |
| Vomiting (intermittent) | 3/51 (5.9%) | 5 |
| General disorders | ||
| Fatigue | 30/51 (58.8%) | 71 |
| Fever | 7/51 (13.7%) | 8 |
| Insomnia | 4/51 (7.8%) | 8 |
| Pain | 3/51 (5.9%) | 5 |
| Weakness | 10/51 (19.6%) | 17 |
| Weight Loss | 7/51 (13.7%) | 16 |
| Metabolism and nutrition disorders | ||
| AST | 3/51 (5.9%) | 4 |
| Hyperglycemia | 10/51 (19.6%) | 25 |
| Hypoalbuminemia | 5/51 (9.8%) | 8 |
| Hypocalcemia | 4/51 (7.8%) | 4 |
| Hypokalemia | 4/51 (7.8%) | 8 |
| Hyponatremia | 8/51 (15.7%) | 15 |
| Musculoskeletal and connective tissue disorders | ||
| Pain (bone) | 3/51 (5.9%) | 3 |
| Pain (jaw) | 4/51 (7.8%) | 4 |
| Nervous system disorders | ||
| Neuropathy (sensory) | 3/51 (5.9%) | 4 |
| Pain (headache) | 3/51 (5.9%) | 5 |
| Respiratory, thoracic and mediastinal disorders | ||
| Cough | 8/51 (15.7%) | 13 |
| Dyspnea | 19/51 (37.3%) | 31 |
| Pain (chest) | 3/51 (5.9%) | 5 |
| Sore throat | 3/51 (5.9%) | 3 |
| Skin and subcutaneous tissue disorders | ||
| Alopecia | 7/51 (13.7%) | 14 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The sponsor can review/embargo results communications prior to public release for a period that is >60 days but ≤180 days from date submitted to sponsor, who may require changes to the communication in order to remove specifically identified confidential information (other than study data) and/or delay the proposed publication to enable the sponsor to seek patent protection for inventions. The PI may not publish its results until 18 mos. after the trial has been completed at all sites.
Results Point of Contact
| Name/Title | John Hainsworth, MD |
|---|---|
| Organization | Sarah Cannon Research Institute |
| Phone | 1-877-691-7274 |
| asksarah@scresearch.net |
- SCRI LUN 122