Pharmacodynamic Study Using FLT-PET/CT in Patients With Prostate and Other Solid Malignancies Treated With an Interrupted High-dose Axitinib Schedule
- Patients must have histologically or cytologically confirmed solid malignancy
(excluding lymphoma) that is metastatic or unresectable and for which no standard
- Patients must have measurable disease
- Must be >/= 18 years of age
- All patients need to be willing to undergo planned pharmacodynamic assessments,
including serial PET imaging, plasma markers, and pharmacokinetic sampling.
- Patients who have had chemotherapy, radiotherapy, experimental therapy or major
surgery within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering
the study or those who have not recovered (to grade -Patients may not be receiving
any other investigational agents.
- Patients with prior anti-VEGF directed therapy may be allowed only if approved by the
PI and greater than 8 weeks since last exposure
- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to axitinib
- Patients with poorly controlled hypertension
- Patients who require use of therapeutic doses of coumarin-derivative anticoagulants
- Patients with any condition that impairs their ability to swallow and retain axitinib
tablets are excluded.
- Patients with any of the following conditions are excluded: Serious or nonhealing
wound, ulcer, or bone fracture; History of abdominal fistula, gastrointestinal
perforation, or intra-abdominal abscess within 28 days of treatment; Any history of
cerebrovascular accident (CVA) or transient ischemic attack within 12 months prior to
study entry; History of myocardial infarction, cardiac arrhythmia, stable/unstable
angina, symptomatic congestive heart failure, or coronary/peripheral artery bypass
graft or stenting within 12 months prior to study entry; History of pulmonary
embolism within the past 12 months; Class III or IV heart failure as defined by the
NYHA functional classification system.
- Patients without appropriate lesion on CT scan for FLT-PET/CT imaging
- CYP3A4 inducers/inhibitors medications will be reviewed by the Principal
- Steroid use is not recommended during axitinib treatment
- Patients with a pre-existing thyroid abnormality who are unable to maintain thyroid
function in the normal range with medication are ineligible.
- Patients with known brain metastases should be excluded
- HIV-positive patients on combination antiretroviral therapy are ineligible