Palladia® and carboplatin combination for dogs with any measureable malignant tumor
Evaluation of toceranib phosphate (Palladia®) in combination with carboplatin in dogs with naturally-occurring cancer
Purpose and Brief Study Description:
Conventional chemotherapy protocols typically include one or sometimes multiple chemotherapeutic agents, that are directly toxic to the cancer cells, administered at maximally tolerated doses and intervals. Newer metronomic (low-dose continuous) chemotherapy protocols exert their anti-cancer activity differently, impacting the tumor microenvironment, angiogenesis and immune system. Furthermore, the mechanisms of acquired resistance to chemotherapy seem different when comparing high-dose conventional chemotherapeutic agents and metronomic agents. This is all strong evidence to support a combined treatment regimen.
Toceranib phosphate (Palladia®) was the first veterinary anti-cancer agent to obtain FDA approval based on demonstrable safety and efficacy in the treatment of canine mast cell tumors. Toceranib has subsequently demonstrated benefit in the treatment of numerous canine malignancies. Toceranib has direct anti-cancer, as well as anti-angiogenic activity, and recent research suggests a role in immune system modulation.
The primary purpose of this study is to establish the safety and maximum tolerated dose of carboplatin when administered in combination with toceranib (Palladia®) in dogs with malignant tumors. The secondary objective of this study is to demonstrate the efficacy/clinical benefit of this chemotherapeutic combination protocol in treating dogs with malignant tumors.
Dogs that have been diagnosed with a malignant tumor and have not been previously treated with either toceranib or carboplatin, are eligible for this study. Dogs must have a measurable tumor at the time of enrollment in this study.
What does enrollment into this trial involve?
All dogs enrolled in this study will receive toceranib administered by mouth every other day for the duration of the study, and carboplatin administered intravenously every 21 days for a total of four treatments. Blood and urine samples will be collected at baseline and immediately prior to each subsequent dose of carboplatin, seven days after each dose and 21 days after the 4th and final dose of carboplatin. Imaging studies will be required for those patients with internal tumors only measurable with x-ray or ultrasound at least twice, but up to four times, during the study.
After study day 84 (or sooner if your dog is removed from this study for any reason), the study will be completed and the oncology clinician will discuss additional and / or ongoing treatment options with you as the dog’s owner and primary care giver.
The cost of the toceranib phosphate (Palladia®) and carboplatin will be paid for by the study. Also covered will be the required recheck appointments, monitoring blood tests, urine tests, blood pressure evaluations and any imaging studies deemed necessary by the clinician. Treatment required for unanticipated side-effects will also be covered by the study up to $100. The owner is responsible for the costs of the initial appointment and the diagnostic work-up required prior to approval and enrollment in the study to ensure your dog is an appropriate study candidate, including the blood tests, urinalysis, blood pressure measurement and any imaging studies.
Please contact Misty Bear, Clinical Trials Coordinator, for more information. Phone: (785)532-3046; email: ClinicalTrials@vet.k-state.edu