A Phase II Single Arm Trial of Single-agent Vinflunine as Second-line Treatment of Advanced Non-Small Cell Lung Cancer
Study Details
Study Description
Brief Summary
This is a Phase II, single-arm study in patients with stage IIIB (with malignant pleural effusion) and IV NSCLC who have been previously treated with a platinum-based doublet.
Each cycle will be 21 days. On Day 1 of each cycle, patients will receive vinflunine 320 mg/m2 as a 20-minute IV infusion.
Patients will continue to receive study treatment until disease progression or unacceptable toxicity.
Patients will be evaluated every 2 cycles for response using RECIST criteria.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Outcome Measures
Primary Outcome Measures
- To determine the 1-year survival rate in patients with stage IIIB-IV NSCLC receiving single-agent vinflunine who were previously treated with a platinum-based doublet. [unk]
Secondary Outcome Measures
- To assess response rate (RR) of single-agent vinflunine in patients with stage IIIB-IV NSCLC who were previously treated with a platinum-based doublet. [unk]
- To assess overall survival in patients with stage IIIB-IV NSCLC receiving single-agent vinflunine who were previously treated with a platinum-based doublet. [unk]
- To determine the progression-free survival (PFS) in patients with stage IIIB-IV NSCLC receiving single-agent vinflunine who were previously treated with a platinum-based doublet [unk]
- To assess time to response (TTR) in patients with stage IIIB-IV NSCLC receiving single-agent vinflunine who were previously treated with a platinum-based doublet. [unk]
- To assess duration of overall response in patients with stage IIIB-IV NSCLC receiving single-agent vinflunine who were previously treated with a platinum-based doublet. [unk]
- To assess duration of stable disease in patients with stage IIIB-IV NSCLC receiving single-agent vinflunine who were previously treated with a platinum-based doublet. [unk]
- To assess the safety of single-agent vinflunine in patients with stage IIIB-IV NSCLC who were previously treated with a platinum-based doublet. [unk]
Eligibility Criteria
Criteria
Inclusion Criteria:
To be eligible for the study, patients must fulfill all of the following criteria:
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Patients must have signed an IRB-approved informed consent.
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Patients must have recurrent or metastatic stage IIIB (with malignant pleural effusion) and IV NSCLC that has progressed after receiving a platinum-based doublet as first-line therapy.
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Patients must have measurable disease, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Previously irradiated lesions will not be allowed as measurable disease.
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Patients must have an ECOG Performance Status of 0, 1, or 2.
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Patients must be <18 years of age.
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Previous chemotherapy must have been completed at least 4 weeks prior to enrollment.
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Patients must either be not of child bearing potential or have a negative serum pregnancy test within 7 days prior to registration. Patients are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or they are postmenopausal for at least 12 months.
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Patients of childbearing potential must agree to use effective contraceptive measures during study treatment and for a reasonable time thereafter.
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Patients must have an absolute neutrophil count (ANC) >1500/uL, platelet count
100,000/uL, and hemoglobin >8 g/dL.
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Patients must have a serum creatinine <2 x institutional upper limit of normal (ULN).
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Patients must have a total bilirubin <2.5 x ULN and aspartate transaminase (AST) <5.0 x ULN.
Exclusion Criteria:
Any of the following criteria will make the patient ineligible to participate in this study:
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Patients previously treated with vinflunine or another vinca alkaloid.
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Patients with untreated and clinically unstable brain metastases.
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Significant history of uncontrolled cardiac disease; i.e., uncontrolled hypertension, unstable angina, recent myocardial infarction (within prior 6 months), uncontrolled congestive heart failure, and cardiomyopathy with decreased ejection fraction.
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Patients with a serious uncontrolled intercurrent medical or psychiatric illness, including serious infection.
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Patient has a co-existing malignancy or had a malignancy diagnosed within the last 3 years, with the exception of basal cell carcinoma or cervical cancer in situ.
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Patient received treatment with a non-approved or investigational drug within 30 days before planned start of study treatment.
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Patient is not completely healed from a previous oncologic or other major surgery.
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Patient is receiving or planning to receive any concurrent chemotherapy not indicated in the study protocol or an investigational agent during the study period.
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Patients who have a history of hypersensitivity to vinflunine or any of the components in vinflunine or another vinca alkaloid.
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Any patient who is pregnant or lactating.
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Any patient who is unable to comply with requirements of study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Veeda Oncology | Houston | Texas | United States | 77042 |
Sponsors and Collaborators
- Veeda Oncology
- Bristol-Myers Squibb
Investigators
- Principal Investigator: Marcos Joppert, MD, Veeda Oncology
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- I-05-009