Status:
COMPLETED
A Phase II Single Arm Trial of Single-agent Vinflunine as Second-line Treatment of Advanced Non-Small Cell Lung Cancer
Lead Sponsor:
Veeda Oncology
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Non-Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 d...
Eligibility Criteria
Inclusion
- To be eligible for the study, patients must fulfill all of the following criteria:
- Patients must have signed an IRB-approved informed consent.
- 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.
- 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.
- Patients must have an ECOG Performance Status of 0, 1, or 2.
- Patients must be \<18 years of age.
- Previous chemotherapy must have been completed at least 4 weeks prior to enrollment.
- 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.
- Patients of childbearing potential must agree to use effective contraceptive measures during study treatment and for a reasonable time thereafter.
- Patients must have an absolute neutrophil count (ANC) \>1500/uL, platelet count \>100,000/uL, and hemoglobin \>8 g/dL.
- Patients must have a serum creatinine \<2 x institutional upper limit of normal (ULN).
- Patients must have a total bilirubin \<2.5 x ULN and aspartate transaminase (AST) \<5.0 x ULN.
Exclusion
- Any of the following criteria will make the patient ineligible to participate in this study:
- Patients previously treated with vinflunine or another vinca alkaloid.
- Patients with untreated and clinically unstable brain metastases.
- 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.
- Patients with a serious uncontrolled intercurrent medical or psychiatric illness, including serious infection.
- 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.
- Patient received treatment with a non-approved or investigational drug within 30 days before planned start of study treatment.
- Patient is not completely healed from a previous oncologic or other major surgery.
- Patient is receiving or planning to receive any concurrent chemotherapy not indicated in the study protocol or an investigational agent during the study period.
- Patients who have a history of hypersensitivity to vinflunine or any of the components in vinflunine or another vinca alkaloid.
- Any patient who is pregnant or lactating.
- Any patient who is unable to comply with requirements of study.
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00251446
Start Date
October 1 2005
End Date
March 1 2008
Last Update
May 11 2012
Active Locations (1)
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1
Veeda Oncology
Houston, Texas, United States, 77042