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Sorafenib in Treating Patients With Refractory Non-Small Cell Lung Cancer
Not Recruiting
Trial ID: NCT00064350
Purpose
RATIONALE: Preclinical studies indicate that sorafenib is a potent inhibitor of Raf kinase in
vitro and in vivo, with significant dose-dependent, anti-tumor activity in four different
human tumor types including colon, pancreatic, lung, and ovarian. This activity was
cytostatic in nature and was maintained if dosing was continued. That is, tumor growth is
suspended while the drug is administered but returns to baseline rates when the agent is
withdrawn. Therefore, the optimal schedule will be an uninterrupted one. To assess the
activity of sorafenib in a timely manner and with a meaningful interpretation, a randomized
discontinuation design was adopted in the present trial, conducted in a population who were
potentially sensitive to sorafenib.
PURPOSE: This randomized phase II trial is studying sorafenib to see how well it works
compared to placebo in treating patients with refractory non-small cell lung cancer.
Official Title
A Double Blind Phase II Study of BAY 43-9006 in Patients With Non-Small Cell Lung Cancer Who Have Failed at Least Two Prior Chemotherapy Regimens
Stanford Investigator(s)
Harlan Pinto
Associate Professor of Medicine (Oncology) and of Otolaryngology - Head & Neck Surgery
Heather Wakelee
Winston Chen and Phyllis Huang Professor
Eligibility
Inclusion Criteria:
- Histologically or cytologically confirmed advanced non-small cell lung cancer (NSCLC)
- Disease must have progressed after at least 2 prior chemotherapy regimens for NSCLC
- Patients must have measurable or nonmeasurable disease
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- AST and ALT no greater than 3 times ULN (5 times ULN in patients with liver disease)
- Creatinine less than 1.5 times ULN or calculated creatinine clearance greater than 50
mL/min
- More than 3 weeks since prior chemotherapy, radiotherapy, immunotherapy or other
investigational drug use
- Recovered from all prior therapy
- Fertile patients must use effective contraception
- Age >= 18
- ECOG performance status of 0-1
Exclusion Criteria:
- Prior primary or metastatic brain or meningeal tumors unless clinically and
radiographically stable and off therapy for at least 2 months
- Active second malignancy
- Clinically evident congestive heart failure, serious cardiac arrhythmias, or symptoms
of coronary heart disease
- Prior radiotherapy to the only site of measurable or evaluable disease unless there is
evidence of disease progression in that site
- Prior exposure to a ras pathway inhibitor (e.g., farnesyl transferase inhibitor)
- Concurrent medications known to be metabolized by the liver with a narrow therapeutic
index, including the following:
- Ketoconazole
- Itraconazole
- Quinidine
- Digoxin
- Cyclosporine
- Ritonavir
- Grapefruit products
- Carbamazepine
- Phenytoin
- Phenobarbital
- Pregnant or nursing
- Clinically serious active infection
- Medical conditions, substance abuse or psychological/social situation that would
preclude study participation
Intervention(s):
drug: Sorafenib
drug: Placebo
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Lisa Zhou
6507364112