ET-743/Ecteinascidin/Yondelis + Doxil Trial


We met with the sarcoma medical oncologist and her fellow at Fox Chase on 3/20/03. We found out the following:


bulletI probably can get on the trial! I need some tests done (liver enzymes) to confirm, but previous blood work makes it look good.
bulletFox Chase has had at least 6 patients on the trial. 3 of these have been sarcomas not responsive to the standard treatments; 2 of these became stable on trial, and 1 had improvement. (They have received 6, 4, and 2 cycles.) They are currently on the 2nd cohort of patients in the trial; they have received 600 micrograms/m^2 of ET-743, and 30 mg/m^2 of Doxil. I will be on the 3rd cohort and will receive 750 micrograms/m^2 of ET-743, and 30 mg/m^2 of Doxil. This will take 1 hour to receive the Doxil and 3 hours to receive the ET-743.
bulletThe length of the cycle is 21 days. So, I will receive chemo every 21 days. I can go for 12-18 months as long as I stay stable or improve. The plan is the same as before: 2 cycles, and a scan to see if there is disease progression.
bulletWe plan for me to start chemo on April 17. Due to the blood work that has to be collected, I have to be in-patient for the first cycle. And, I will need blood work done on the day after chemo, and the day after that. I also need blood work on the 8th day after the chemo for the first 3 cycles. So, I will have to go to Philly quite a bit in the next few months.
bulletThe most likely side effects from the ET-743 are fatigue, kidney functions changes, elevated liver enzymes, and low white blood counts. The most likely side effects from the Doxil are vomiting/nausea, fatigue, elevated liver enzymes, low white blood counts, and mouth sores. I'll probably keep my hair. To reduce the chance of liver problems, I will take a steroid (dexamethasone) before and after the chemo. (Some of the drug-related deaths on previous phase 1 ET-743 trials were due to these liver problems.)
bulletI will need baseline tests; ECHO, chest CT scan, and bloods.
bulletI'll need a port installed.
bulletThe doctor wants me to have a brain MRI, an eye doctor appointment, and an x-ray of my hip.



My schedule of appointments was:

bulletMarch 31: office visit with port doctor
bulletApril 3: doctor's appointment to sign the consent form again. brain MRI, hip x-ray, blood
bulletApril 4: eye doctor
bulletApril 15: chest CT scan at Columbia, port installation, ECHO
bulletApril 24: first cycle of chemo. Show up at 8am, get EKG, see doctor, receive chemo; leave April 27 around 8pm.
bulletApril 26: abd. and pelvic CT scans, blood work.
bulletMay 15: second cycle of chemo.

June 2: CT scans.


Based on the disease progression seen in the CT scans on June 2, I am moving to another treatment.




listing of phase 1 trials at Fox Chase (search for "ET-743").

bulletET-743 pointers.

Copyright 2003 The Shriver Family: Last modified: 01/06/04.