The Pharmacokinetic of Capecitabine in Cancer-Bearing Dogs, Part 2
Purpose of Study
Canine malignant cancers are a devastating reality to many dog owners. Treatment options are often limited by pet behavior, owner finances and time commitments, and the availability of veterinarians who can safely administer chemotherapy. Oral chemotherapy has become increasingly popular because it often costs less than injectable chemotherapy and can be given in the comfort of the patient’s home.
Capecitabine is a well-tolerated, oral chemotherapy drug used in humans for a wide variety of carcinomas including breast cancer, colorectal cancer and head and neck carcinomas. This chemotherapy drug has a short half-life in humans, allowing for quick dose adjustments if side effects are noted. During the first part of this study, we measured the levels of capecitabine in the blood after a single dose was given and looked at how well dogs tolerated the drug. All five enrolled dogs with advanced tumors tolerated capecitabine well and two had stable disease while on this chemotherapy drug.
The purpose of this second part of the study is to learn more about tumor response to capecitabine in a larger number of dogs. We hope that this study may provide support for the use of oral capecitabine chemotherapy in dogs with carcinomas.
Once your dog is enrolled, this study covers the cost for 28 days of capecitabine, study-related oncology recheck examinations, and study-related lab work and imaging (if imaging is deemed necessary for tumor measurement). If your dog tolerates capecitabine well, you have the option of continuing this drug outside of the study, at your own expense, and under the supervision of your WSU Veterinary Oncologist.
It is possible that your dog’s carcinoma will not respond to treatment with capecitabine, however, your dog’s participation in this study will help us explore which types of carcinomas are most responsive to this oral chemotherapy drug.
This study is being conducted on dogs that have been diagnosed with a carcinoma. Dogs may be of any age, breed and gender. To be eligible for this study, dogs must have an appointment with the Oncology Service at the WSU Veterinary Teaching Hospital (WSU VTH) for confirmation/diagnosis of their disease and possible treatment. Dogs enrolled in this study must have a CBC and Serum Chemistry within 2 weeks of enrollment, more than 2,800 neutrophils, and no evidence of any other major disease that would result in a life expectancy of one week or less.
This study involves giving oral chemotherapy, on a set schedule, to your dog at home and 2-3 visits to the WSU Veterinary Teaching Hospital: the baseline day, rest-period blood work, and the final study day.
Baseline Day: Once enrolled in the study, if your dog does not have current blood work, blood will be drawn for a complete blood count (CBC) and serum chemistry. We will record measurements of your dog’s tumor, which may require imaging (X-ray, ultrasound, CT) and do a quick test to look at your dog’s eyes. Your dog will be sent home with 28 days of capecitabine, instructions, and a daily health log.
Capecitabine Administration Period: At home, you will give your dog capecitabine for 14 consecutive days. Days 15-21 you will NOT give capecitabine to your dog. During this period, we highly recommend that your dog has a CBC and examination. This can be done with your regular veterinarian or at the WSU VTH (if done at the VTH, the study will pay for associated charges). After the 7-day rest period, you will give your dog capecitabine for another 14 consecutive days.
Final Study Day: Within 3 days of the last dose of capecitabine, your dog will return to the WSU VTH for a physical exam, eye exam, recheck blood work and tumor measurement. After this appointment, your dog’s study enrollment will be completed.
Owners are responsible for bringing their dog to the WSU VTH for the oncology appointment. They are responsible for the costs associated with the diagnosis of their dog’s carcinoma. To be enrolled in this study, owners must be willing to follow instructions/safety protocols to give their dogs an oral chemotherapy drug at home, complete a daily log of their dog’s health while on the drug, and return to the WSU VTH for the final study day.