Archive for the ‘lu-177 CLEMENT study’ Category

CLEMENT Study- Day 1

Monday, July 16th, 2007

The week started Monday after an early morning trip from Busselton to Fremantle Hospital (three hours drive). It was a full day of testing and scans. We also met with Eric’s oncologist, Dr Philip Claringbold. Dr Claringbold is overseeing the Lu-177 CLEMENT study, so he is now doubling up as Eric’s oncologist.

Dr Claringbold prescribed anti-nausea drugs as well as the Capecitabine tablets. The Capecatibine is the drug being used in the study to hopefully accentuate the effectiveness of the Lu-177. It is this effect that the study is really looking at. Capecitabine is normally a chemotherapy drug used in the treatment of breast cancer and has been known to cause significant nausea.

In the case of the CLEMENT study the dosages used is about half the breast cancer treatment rate and so it is expected that the nausea from the drug will be significantly reduced if not felt at all.

There were transmission and CT with contrast scans, blood tests and of course the collection of the 5HIAA 24 hour urine kit.  Dr Harvey Turner took quite a bit of time to explain all the procedures and answer our questions and while Eric was having his scan took Leonie on a guided tour to the day surgery unit so we would not get lost in the morning. 

We had Tuesday off ….while Eric carried his collection bottle in a discrete bag around Perth… and returned to Fremantle Hospital Wednesday morning at 8:15 am to the Day Surgery Unit.

Wednesday, June 6th, 2007

CLEMENT STUDY - Eric’s In!

We have just returned from Fremantle and Eric’s visit to the Nuclear Medicine Department and seeing Dr Harvey Turner.

Eric has been offered a place in Dr Turner’s CLEMENT Study. CLEMENT stands for Capecitabine-radiosensitizing Lutetium-177 -octreotate Endoradiotherapy Management of Endocrine Neurogenic Tumours. This study is a result of collaboration with the esteemed nuclear physicians at Erasmus Medical Centre in Rotterdam and is physician sponsored. This means that no drug company is involved in the study.

This is a pilot study where Lutetium-177 (Lu-177) tagged Octreotate is combined with a radiosensitizing chemotherapy agent (capecitabine) to enhance the effectiveness of the Lu-177.

Professor Krenning and Dr Kwekkeboom in Rotterdam have recently reported and published their findings from a study of Lu-177 octreotate only therapy delivered to 131 patients in the Journal of Clinical Oncology -Volume 23, Number 12, April 20 2005. Nearly half of their patients responded favourably to the therapy. This is extremely good news!

We are hoping that the combined therapy will prove to more effective than the Lu-177 octreotate therapy only. This is one of the goals of the study.

Eric had an octreoscan today to ascertain that his tumours have a good uptake/affinity for the octreotate- which they certainly do. Along with other factors this makes Eric a good candidate for the study.

The regime that Eric will undergo is 4 rounds of therapy 6 to 11 weeks apart- depending on the repsonse and ability of the kidneys and platelet counts etc to recover from the therapy.

Eric will undergo treatment along with three other candidates. The treatments will be timed in such a way that they can be given to the four candidates at the one time. This helps to limit costs and is more efficient for the study. Of course all treatments are provided to Eric free of charge.. medical expenses are covered for all Australian residents who choose to be treated as public patients.

Treatment Regime

Monday

After baseline imaging and blood work Eric will meet with the study’s oncologist Dr Philip Claringbold for assessment and prescription of the Capecitabine.

Wednesday

Admission on a day basis to Fremantle Hospital where the therapy will be administered followed by 4 hours of intravenous administration of standard amino acid solution to help protect the kidneys from the effects of the treatment.

After further imaging Eric will be allowed to go home (well at least to our friends home in Perth).

Thursday, Friday and the following Monday

Serial Gamma imaging at Fremantle Hospital to help define the uptake of the Lu-177.

Eric will then be able to return to Busselton until the next round.

Side effects are expected to be limited to a little nausea for 24 hours or so which apparently can be easily controlled with various drugs and there is also a possibility of some hair thinning around week 3 in each cycle.

This process will be continued for another three rounds after which further imaging and final results will be collated.
We are both looking forward to the study and consequent treatment. We have a tentaive start date of Monday 16 July with the first treatment on Wednesday 18 July. We will confirm this as information comes to hand.

We were very please to meet with Dr Turner who is extremely helpful and was very keen to make sure Eric and Leonie understood the study, treatments and all the possibilities. He took a lot of his valuable time to ensure we felt at ease with the process and we were very appreciative of his time and the effort he took to inform us.