Study: Examining the Efficacy of Toceranib Phosphate (Palladia®) as a Primary and/or Adjuvant Agent in
the Treatment of Canine Nasal Carcinoma

Available at the following locations:
ALABAMA: Auburn University Small Animal Teaching Hospital, (334-844-4690; Dr. Annette Smith at smith30@auburn.edu)
ARIZONA: Southwest Veterinary Oncology, Gilbert and Tucson, AZ (480-635-1110; 520-888-3177)
NEW JERSEY: Redbank Veterinary Hospital, Tinton Falls, New Jersey (732-747-3636)
WASHINGTON: Washington State University Veterinary Teaching Hospital, (509-335-0711)

Eligibility: Dogs must meet the following criteria:
  • Have histologically confirmed diagnosis of nasal carcinoma
  • Have a tumor that does not extend through the cribiform plate into the brain parenchyma (evaluated on computerized
    tomography scan)
  • Have no evidence of metastatic disease at the time of enrollment
  • Have no other serious health problems that are incompatible with the study (as renal, cardiac or hepatic insufficiency)
  • Have a life expectancy greater than 6 weeks

Background: Nasal tumors comprise approximately 1% of canine tumors and carcinomas are diagnosed in 60-70% of cases.  
Radiation therapy is the treatment of choice and is the only modality which has resulted in improvement of survival times.
Reported survival times average 10-14 months following radiation therapy. The maximum tumor response is noted at
approximately 3 months after completion of therapy and long term control rarely occurs. Both VEGF and VEGFR have been
documented to be expressed in canine nasal carcinomas suggesting that inhibiting the VEGFR signaling axis may be
therapeutically useful. This is supported by recent data presented at the 2010 Annual Veterinary Cancer Society Conference
demonstrating clinical benefit in dogs with recurrent nasal carcinomas treated with the small molecule receptor tyrosine
kinase inhibitor Palladia that inhibits signaling of VEGFR family members. One of the dogs experienced a complete response
to therapy after failing radiation, suggesting that Palladia may have single agent activity against this disease. While there are
no published data demonstrating the use of Palladia in combination with radiation, evidence from mouse models  indicates
that VEGFR inhibitors can act synergistically with radiation therapy without an increase in toxicity. Indeed, data presented at
the VCS meeting demonstrated no enhanced toxicity when radiation was combined with Palladia for the treatment of mast cell
tumors in dogs.

Purpose: The purpose of this study is to define the biologic activity of Palladia alone or in combination with radiation therapy
for the treatment of nasal carcinoma.

Study design: Dogs with confirmed diagnosis of nasal carcinoma will receive Palladia every other day and depending on
owner preference, will also receive radiation therapy (10 daily treatments over two weeks). Recheck exams will be performed
at 1, 2, and 4 weeks after initiating Palladia, and then every 4 weeks thereafter for a total of 1 year.  For those dogs that
receive radiation therapy, a CT scan will be repeated by the Radiation Oncology Service at 3, 6, and 12 months following
radiation treatment. For those dogs that do not receive radiation therapy, a CT scan will be performed at 3 months following
therapy only.

Owner requirements: Owners are responsible for the costs of the radiation therapy (approximately $2200 for the entire 2
week protocol). The majority of the costs for recheck visits after initiation of Palladia therapy are covered by the clinical trial
amounting to a savings of approximately $3100. Owners are responsible for a small fraction of the costs for these recheck
visits; this amounts to approximately $700 over the course of the 1 year period ($60/month). Owners are responsible for any
additional costs that arise from other medications, and the treatment of potential complications during the study.

Financial incentive: The study will cover most of the recheck visits and tests (bloodwork, CT scans) performed after the
Palladia therapy is initiated representing a savings of approximately $3100.


WISCONSIN
Study: Tomotherapy clinical trial for dogs with nasal tumors: Conformal avoidance of eyes and brain.
Location:  University of Wisconsin Veterinary Teaching Hospital, Madison, WI
Phone:  (608) 263-7600
www.uwveterinarycare.wisc.edu/rdvm/clinical_trials.html

Summary: Helical TomoTherapy ™ is a combination of a linear accelerator and a helical CT scanner that delivers highly
precise radiation to treat tumors while avoiding critical normal tissues.  This radiation therapy machine was developed at the
University of Wisconsin.  In a previous study the UW-SVM treated 31 dogs with nasal tumors delivering dose to the tumor
while avoiding the eyes, which significantly reduced ocular toxicity.  In this new study we are evaluating molecular imaging of
the tumor to guide and individualize each dog’s treatment plan with the goal to prolonging overall survival.  Owners are
responsible for the cost of the initial staging (approximate cost $1000-1200). Owners will pay $1200 toward this state-of-the-
art therapy (typical cost is $4500-5000) and owners will pay for medications.

Financial incentive: The study will pay for the following:
  • Radiotherapy treatment with Helical TomoTherapy ™ & anesthesia
  • Molecular imaging (PET/CT’s), tumor biopsy correlated with imaging, & anesthesia
  • Ophthalmic exams and CBC/serum biochemistry profile/urinalysis
  • Hospitalization during treatment and imaging
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Last updated 8/16/13
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