Status:
COMPLETED
Study of Combination of Metronomic Oral Vinorelbine and Sorafenib in Patients With Advanced Non-small Cell Lung Cancer
Lead Sponsor:
National Cancer Centre, Singapore
Conditions:
Non-Small Cell Lung Cancer
Eligibility:
All Genders
21+ years
Phase:
PHASE1
Brief Summary
Targeting the blood supply of cancer, called anti-angiogenesis is a new but proven treatment strategy. There are two ways of achieving this effect. The first way to specifically target the molecular p...
Detailed Description
Phase I Dose-finding study: The patients will be divided into 3 cohorts (15 patients per cohort), each cohort receiving a fixed metronomic (thrice a week) dose of oral vinorelbine at 60 mg/week, 90 mg...
Eligibility Criteria
Inclusion
- Patients must have histologically or cytologically confirmed NSCLC
- At least one or 2 prior lines of chemotherapy, including oral EGFR tyrosine-kinase inhibitor for metastatic disease or locally advanced unresectable disease. There should be at least 4 weeks since prior chemotherapy or radiation therapy; patients who decline conventional chemotherapy or oral EGFR tyrosine-kinase inhibitor as salvage 2nd or 3rd line treatment are also eligible.
- Minimum body-surface area (BSA) of 1.4 m2 at point of recruitment. This is a safeguard against recruiting small-built patients who may experience adverse reaction on absolute dosing of oral vinorelbine. At this body surface area, the maximum dosing of oral vinorelbine at 120 mg/week is equivalent to 86 mg/m2/week for a patient with BSA of 1.4 m2.
- Age \>21 years
- ECOG performance status \<2 (Karnofsky \>60%)
- Patients must have normal organ and marrow function as defined here: leukocytes \>3,000/mcL, absolute neutrophil count \>1,500/mcL, platelet count \> 100,000/mcL, serum bilirubin within normal institutional limits, AST(SGOT)/ALT(SGPT) \<2.5 X upper limit of normal, and creatinine within normal institutional limits or creatinine clearance \>60 mL/min/1.73 m2 for patients. These tests must be done within 1 week of study treatment.
- Ability to understand and the willingness to sign a written informed consent document
Exclusion
- Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
- Patients receiving any other investigational agents
- Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Oral Vinorelbine or other agents used in study
- Prior and / or concomitant treatment with drugs known to induce or inhibit cytochrome P450 3A4: phenytoin, carbamazepine, barbiturates, rifampicin, imidazole antifungals (such as ketoconazole, fluconazole, itraconazole, metronidazole), omeprazole and ritonavir. Patients who are taking gastric acid-lowering agents such as H2 antagonist or antacids will be evaluated regarding the need to continue with these medications. If discontinuation of these medications is medically contraindicated, the patient will be excluded as these agents are known to lower the solubility of sorafenib and hence may limit their efficacy.
- Significant malabsorption syndrome or disease affecting the gastro-intestinal tract function
- Significant peripheral or autonomic neuropathy affecting sensation or bowel motility
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Uncontrolled hypertension defined as systolic blood pressure \>150 mmHg or diastolic pressure \>90 mmHg despite optimal management
- Pregnancy or breast-feeding or women of childbearing potential not using effective contraception
- Evidence or history of bleeding diathesis or coagulopathy
- Thrombotic or embolic events such as cerebrovascular accident including transient ischemic attacks within the past 6 months
- Pulmonary hemorrhage/bleeding event \>CTCAE grade 2 within 4 weeks of recruitment
- Any other hemorrhage/bleeding event \>CTCAE grade 3 within 4 weeks of recruitment
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT00870532
Start Date
June 1 2008
End Date
September 1 2013
Last Update
November 4 2013
Active Locations (1)
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1
National Cancer Centre, Singapore
Singapore, Singapore, 169610