View Clinical Trial (Medical Research Study)
Pharmacodynamic Study Using FLT-PET/CT in Patients With Prostate and Other Solid Malignancies Treated With an Interrupted High-dose Axitinib Schedule
| City: |
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Madison |
| State: |
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Wisconsin |
| Zip Code: |
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53792 |
| Conditions: |
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Solid Malignancies - Metastatic Castrate-resistant Prostate Cancer |
| Purpose: |
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The main purpose of this study is to learn more about the safety of an investigational drug,
axitinib. An investigational drug is a drug that has not been approved by the Food and Drug
Administration (FDA) and is available for research use only. Researchers will also see what
changes happen to the tumors while taking the axitinib and after it is stopped (during the
scheduled breaks), and what changes in the tumor may be responsible for this growth. This
will be done by using a special kind of scan called an 18F-FLT PET/CT. This scan is
considered an investigational type of scan and is not used for clinical care. These scans
are not approved by the FDA, their use in this study is just for research purposes.
In addition, the investigators want to find out how the drug is processed and distributed in
the human body. The investigators will also look at how different types of cancer are
affected by axitinib.
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| Study Summary: |
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| Criteria: |
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Inclusion Criteria:
- Patients must have histologically or cytologically confirmed solid malignancy
(excluding lymphoma) that is metastatic or unresectable and for which no standard
therapy exists.
- 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.
Exclusion Criteria:
- 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
Investigator.
- 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
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| NCT ID: |
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NCT01540526 |
| Primary Contact: |
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Principal Investigator
Glenn Liu, M.D.
University of Wisconsin, Madison
Clinical Trials Office (Cancer Connect)
Phone: (800) 622-8922
Email: cancerconnect@uwcarbone.wisc.edu
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| Backup Contact: |
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N/A |
| Location Contact: |
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Madison, Wisconsin 53792
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 24, 2013 |
| Modifications to this listing: |
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