ALABAMA
Study: A randomized, masked, placebo controlled field study to determine efficacy and safety of Paccal
Vet in dogs with non resectable mammary carcinoma of stage III-V
Location:  Auburn University-Auburn, Alabama
Contact: Annette Smith
at smith30@auburn.edu or 1-334-844 4690
www.vetmed.auburn.edu/wp-content/uploads/2015/03/CICF-Paccalvet-11-10-2014.pdf

Eligibility:
Female dogs of any size or breed that have mammary carcinoma that cannot be removed with surgery, or you have declined
surgery, may participate. The tumor must be at least 1 cm with lymph node metastasis (tumor spread), or more than 5 cm
without lymph node metastasis. Dogs with tumor spread to other organs are also eligible, although their life expectancy must
be more than one month.

Objective: Paclitaxel is one of the most commonly used drugs in human cancer treatment. Previously, it was not safe for use
in dogs due to allergic reactions to the formulation. A new formulation of the drug (Paccal Vet®) has eliminated this concern.
Since paclitaxel is used in women with breast (mammary) cancer with favorable results, this chemotherapy drug may be
useful in dogs, as well. Good treatment options beyond surgery for dogs with this commonly occurring cancer have not been
available. Previous research in dogs has determined a reasonably safe dose of Paccal Vet®, as well as shown some
response in mammary cancer in dogs (about 60% of patients treated had tumor shrinkage). This study is being performed to
better document the response of mammary cancer in dogs to this drug, in pursuit of FDA (Food & Drug Administration)
approval.


Summary: Mammary carcinoma is a tumor type that does not have good treatment options for systemic disease spread
(metastasis). Paclitaxel is a drug that is very effective in human breast cancer, and has shown some effectiveness in dogs
with mammary tumors. Previously, this drug was not used in dogs due to significant allergic-type reactions to some of the
products in the formulation. A new formulation, PaccalVet, avoids these allergic reactions and has now received conditional
approval and is available to treat mammary carcinomas and squamous cell carcinomas as first-line treatment if the tumors
cannot be removed. This study is part of a trial to further define PaccalVet's effectiveness in treating mammary carcinoma..

Compensation: Costs of Paccal Vet® treatment and monitoring related to the mammary tumor in this study are covered by
the sponsor. If side effects related to treatment occur, these costs will be covered by the sponsor. A prepaid card will be
provided to you by the sponsor at each scheduled clinic visit ($160 for each 3-week treatment cycle, and $65 for each
monthly follow-up visit). During the initial 12 weeks of active drug administration, if your dog’s tumor progresses and your pet
is dismissed from the study, you may contact the sponsor for coverage of costs of further treatment at the clinic of your
choice. You are responsible for the costs of any further treatments chosen after the study period has ended or dismissal
from the study.
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Last updated 02/18/2017
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