Effects of Ladarixin on quality of life and tumor response in dogs receiving chemotherapy

The purpose of this clinical trial is to evaluate whether a drug called Ladarixin when given orally to dogs with cancer that are receiving chemotherapy can help decrease the side effects associated with that treatment. Ladarixin is a drug that blocks IL-8, a factor released into the bloodstream that causes inflammation and can contribute to fatigue/tiredness. IL-8 has also been shown to help block an effective immune response to cancer. We have previously evaluated ladarixin in dogs with cancer that were not receiving chemotherapy to identify the dose and determine if there were any side effects from the drug given alone. Ladarixin was very well tolerated, and it has since been used in combination with some other anti-cancer agents in dogs to determine if it helps to improve response to treatment. In the current study, we will be giving ladarixin in combination with one of two agents used to treat cancer in dogs: doxorubicin or toceranib. Doxorubicin is a chemotherapy that is given by intravenous injection and used to treat several different cancers in dogs. Toceranib is an oral anti-cancer drug that is given to treat other types of cancers in dogs. Depending on the type of cancer your dog has, he/she will receive either doxorubicin or toceranib. To more accurately determine whether Ladarixin is truly affecting the side effects from treatment, your dog will alternatively receive Ladarixin or placebo (you will not know which one is being given) over the course of the study. We will track your dog’s quality of life using a special questionnaire, document any side effects and determine how well he/she is doing overall during the cancer treatment.

Inclusion Criteria

Dogs diagnosed with histologically or cytologically confirmed solid tumor (carcinoma, sarcoma, melanoma, mast cell tumor) or B cell lymphoma are eligible to enroll. The patient may have failed standard therapy (recurrent disease) or there may be no other known effective antineoplastic therapeutic options, or the owner may elect to enter the patient in lieu of standard therapy.

Exclusion Criteria

•    Dogs with significant cardiovascular disease.
•    Less than 2 weeks from a major surgical procedure.
•    Any serious systemic disorder incompatible with the study (at the discretion of the principal investigators).

Client Benefits

The benefit to your dog is that he/she may have an improvement in quality of life associated with Ladarixin administration (i.e., it may reduce any side effects associated with chemotherapy treatment) It is also possible that the Ladarixin may have a direct effect on the cancer by helping to stimulate the immune system to kill the tumor cells.

All costs associated with this study including office visits, bloodwork, chemotherapy and ladarixin/placebo administration are covered by the study. The treatment of side effects from the doxorubicin or toceranib, should they occur, are NOT covered by the study. Additionally, should your dog develop a condition unrelated to the cancer (bladder infection, ear infection) costs for treating those will NOT be covered by the study

Sample or Data Requirements

Once your dog is determined to be eligible for the study, baseline blood samples will be taken and your dog will receive either doxorubicin or toceranib, depending on the type of cancer. Both of these drugs will be given at the dose and regimen normally used to treat cancer in dogs. Your dog will also be randomly assigned to either recieve placebo during the first cycle/first 4 weeks of treatment or ladarixin (you will not know which one). The ladarixin (or placebo) will then be switched during the next cycle/next 4 weeks so that in total, your dog will have half of the treatment time on placebo and half of the treatment time on ladarixin. At each study visit, we will evaluate your dog’s quality of life, side effects from treatment and overall health