Olaparib + Meloxicam for Feline Mammary Carcinoma
Logan Kursh, VMD
Medical Oncology Resident
[email protected]
Jaime Modiano, VMD, PhD
Perlman Professor of Oncology and Comparative Medicine, Veterinary Clinical Sciences
[email protected]
Antonella Borgatti, DVM, MS, Dipl. ACVIM (Oncology), Dipl. ECVIM-CA
Professor, Oncology, Veterinary Clinical Sciences
[email protected]
Logan Kursh, VMD
[email protected]
Study title
A Pilot Study Evaluating PARP Inhibition in Combination with NSAID Therapy in Cats with Mammary Carcinoma
Purpose of study
Feline mammary carcinoma (FMC) is an aggressive cancer with limited effective treatment options and poor long-term outcomes. In addition to exhibiting similar biologic behavior, there is a growing body of evidence indicating that many FMCs display molecular characteristics similar to triple-negative (TNBC) and basal-like subtypes of human breast cancer. These aggressive forms of human breast cancer have shown encouraging responses to olaparib, an oral Poly (ADP) ribose polymerase inhibitor. This medication alters DNA repair pathways, which are thought to be a major contributor to resistance to traditional chemotherapy. Olaparib is well-tolerated in humans, and early data obtained by researchers at the University of Illinois suggests that it is well-tolerated and shows clinical activity in cats with cancer.
This is a pilot study that combines olaparib and a non-steroidal anti-inflammatory medication (meloxicam) for treatment of FMC. Meloxicam is used as a pain medication, and it has direct anti-cancer effects for many carcinomas.
Eligibility criteria
Cats must:
- have spontaneous mammary tumors measuring at least 1 cm in size with a confirmed histologic or cytologic diagnosis
- adequate organ function as indicated by standard laboratory tests (complete blood count, serum biochemistry panel, urinalysis)
- ANC >/= 1000/uL and platelet count >/= 100,000/uL
- liver: total bilirubin </=1.5x institutional upper reference limit (URL); ALT</=3x URL
- kidney: creatinine <2.8 mg/dL
- otherwise be healthy with no clinically significant findings on medical record review, physical examination, or laboratory profiles
- have an expected life expectancy of at least 3 months
- not be pregnant or lactating
- not have necrosis involving more than 10% of the visible tumor
- not have any serious medical condition deemed incompatible with the study as determined by the principal investigators
- be off of all drugs that could affect their immune response for at least 14 days prior to enrollment, including concurrent complementary or alternative medicines (concomitant medications will be permitted at the investigators' discretion)
- not have treatment with radiation, chemotherapy, or other investigational drugs within 14 days of study enrollment
Procedures
Screening (day 0): physical exam (PE), blood and urine testing, tumor measurement, chest x-ray, tumor biopsy if needed, quality of life (QOL) survey
Follow up visits (days 7, 14, 42): PE, bloodwork, tumor measurement, QOL survey
Restaging visit (day 28): PE, bloodwork, tumor measurement, chest x-ray, QOL survey
Study exit (day 56): PE, blood and urine testing, tumor measurement, chest x-ray, QOL survey
Unscheduled visits (if needed between study visits): PE, blood and urine testing, chest x-rays as needed
If your cat becomes ill from the study medications and requires hospitalization, we will discuss admission to the ICU for supportive care.
Costs
Owners are responsible for the costs associated with obtaining a diagnosis of feline mammary carcinoma prior to enrollment.
Screening for study enrollment (bloodwork, urinalysis, chest x-rays, tumor biopsy if needed) will be covered by the study. The study medications (olaparib, meloxicam) and required visits, bloodwork, and chest x-rays will be covered by the study. You will receive a credit of $2000 toward the surgical removal of your cat’s tumor at the University of Minnesota or with one of our partners. Should your cat develop a complication from the study medications, $1000 toward the cost of treatment at the University of Minnesota will be covered. Unrelated health concerns (e.g. ear infections, ingestion of foreign material) are not covered by the study.