NCT01954745

Summary and Research

A Phase II Study of Cabozantinib (XL-184) Monotherapy in Patients With Advanced Cholangiocarcinoma After Progression on First or Second Line Systemic Therapy

Details regarding the trial available here.

Some research on Cabozantinib:

Two Alliance Studies, One Drug: A Closer Look at Cabozantinib

Poster of results for Phase 2 trial with Cabozantinib and Solid Tumors

Cabozantinib and Prostate Cancer: Inhibiting Seed and Disrupting Soil?

Cabozantinib as a novel therapy for renal cell carcinoma.

The antiangiogenic ceiling in hepatocellular carcinoma: does it exist and has it been reached?

Participant Experiences and Suggestions

Member bananaf1sh from CCF Forums:

January 2014

My mom is on the Cabozantinib clinical trial at Mass General, and I am posting this in the hopes that it’ll be useful for anyone considering the trial. Sorry in advance for the long post. The quick & dirty is that my mom is tolerating the drug well, just as she tolerated being on chemo well.

Some background information:

- This clinical trial, though in Phase II, is the first trial where Cabozantinib is being tried on only cholangiocarcinoma patients. The Phase I tested the drug on thousands of other cancer patients with solid tumors to determine the safety in dosage. The Phase II trial is for cc patients for whom one or two treatments with chemotherapy did not work.

- The trial began in September, 2013. There ARE patients who have been on the drug for at least three months who have not shown progression in the disease, though there are patients whose cancer has progressed and have come off the drug.

Financial aspects of being on the trial:

- The trial pays for the drug and any special care (like the 3-day biomarker – see below)

- Lab tests, scans, stent placements – all these are considered standard care and the patient’s responsibility

(Also FYI: Hospitals in Massachusetts do not provide any financial assistance to non-MA residents)

- For those traveling from out-of-state, the Lazarex foundation offers reimbursements on gas (or other travel costs) and lodging

The trial schedule (my mom will be on the drug for as long as it is effective; one cycle is one month):

- First week: two visits to get lab work

- Second & third week: lab work

- After the third week, lab work every other week

- CT scan after two cycles, or two months

- After cycle three, or three months, lab work once a month

Below is a timeline so far, to indicate how long everything took for my mom to get started on the trial.

Dec. 23, 2013: My mom finishes her fourth cycle on Gem/Cis.

Dec. 31, 2013: CT scan on 12/30 reveals an increase in tumor and mets. MSKCC recommends FOLFIRI. I start looking for clinical trials at the recommendation of Percy from the discussion board. I email Dr. Andrew Zhu, the primary investigator of the Cabozantinib clinical trial at Mass General. He emails me back the next day, promising someone from Mass General will get in touch with me.

Jan. 2, 2014: I get an email from the trial’s coordinating nurse who tells me to establish a medical record number for my mom. They also tell me what they need. I contact my mom’s primary ONC’s office at MSKCC, and they are incredibly helpful about forwarding everything. They tell me Dr. Lipika Goyal, Dr. Zhu’s co-investigator, can see my mom on Jan. 10. I express concern about the possibility of delaying her treatment (following Percy and Marion’s advice), and they move up her appointment to Jan. 7.

Jan. 7, 2014: Appt at Mass General. We meet with Dr. Goyal and Dr. Hong, a radiologist. I already detailed this meeting in another post. We’re given several options for systemic treatment, one of which is Cabozantinib. My mom signs the consent form to be on the trial the next day & gets blood work done. Dr. Goyal, by the way, turns out to be one of the most compassionate and knowledgeable doctors we've met so far on this journey.

Jan. 21, 2014 (CYCLE 1; Day 1): Blood work at Mass General. Given my mom’s last chemo, this is the earliest she can start taking the pill. She is given a 30-day supply of the pill. She is to take 3 pills a day (60 mg total) every day on an empty stomach (2 hours after eating). She is told not to eat anything for an hour afterwards. She decides that the best time to take the pills is after dinner, before going to bed. This has been working out well.

Jan. 23, 2014 (3-day biomarker): Blood work at Mass General to see if there are any alarming reactions to the pill. Nothing noteworthy, though maybe a slight increase in tiredness.

Jan. 28, 2014 (CYCLE 1; Day 8): Blood work at Mass General. Her liver test numbers keep going up, but we’re told that it’s to be expected while on the drug. Her platelets are normal. My mom doesn’t have much to report in terms of side effects, or at least any that the medical team seemed concerned about.

I know Nicole’s mom (NewfoundLake) is also taking Cabozantinib, and Nikki’s dad (Nikki4470) was considering it. I hope we can keep adding to the post and share as much information as we possibly can.