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Posted

Phase I Trial in Santa Monica, California

***Trial Summary***

Short Title

CP-751,871 in Combination With Sunitinib (SU11248,Sutent) With Advanced Solid Tumors

Patient Abstract

The study is being conducted to determine the maximum tolerated dose, overall safety and tolerability profile, and pharmacokinetic profile of CP-751,871 and sunitinib when given in combination with advanced solid tumors.

Terms

This is an abstract courtesy of PDQ®, an NCI database that contains the latest information about cancer treatment, screening, prevention, genetics, and supportive care, plus a registry of clinical trials.

***Health Professional Summary***

Full Title

Phase 1, Open Label, Sequential Cohort, Dose Escalation Study of CP-751,871 in Combination With Sunitinib in Patients With Advanced Solid Tumors

Protocol Entry Criteria

Inclusion Criteria:

- Histologically or cytologically confirmed advanced solid tumors relapsed or refractory to standard therapy or for whom no standard therapy exists.

- ECOG Performance Status of 0, 1, or 2

- Adequate bone marrow, renal, and hepatic function

- No mitral valve regurgitation greater than mild as determined by Doppler echocardiogram

Exclusion Criteria:

- Concurrent treatment with any antitumor agents with the exception of LHRH agnosits for prostate cancer patients

- Treatment with any other investigational therapy within 4 weeks prior to study treatment

- Major surgery within 4 weeks of study treatment

- Ongoing cardiac dysrhythmias of NCI CTCAE Grade 2 or greater

- Significant active cardiac disease

Terms

This is an abstract courtesy of PDQ®, an NCI database that contains the latest information about cancer treatment, screening, prevention, genetics, and supportive care, plus a registry of clinical trials.

***Trial Contact Info***

Site Name: Premiere Oncology

City: Santa Monica

State: CA

Protocol ID: A4021024...NCT00729833

Institutional ID:

Contacts:

Name: Marilyn Mulay

Role: Study Coordinator

phone: 310-633-8400

fax:

email: mmulay@premiereoncology.com

------------------------------

On a personal note, as many of you know, I whined all last summer about not being able to get CP751,781 due to its high efficacy in earlier trials for those of us who have squamous cell cancer.

I therefore have no rational explanation as to why, after receiving the above notice on 12/11/08--almost a month ago--I have taken no action on it all. :(

Partly, of course, it has to do with concern over the severity of side effects (and until I call, I won't know if there are any side effects), as well as the location (but again, until I call, I won't know how often I'd have to go to Santa Monica, or even if I'd have to go there at all). Lastly, there's the fact that for whatever reason, I'm still alive despite the fact that I'm undergoing no treatment at all. :(

All of which is totally nutty, of course, since all I need to do is make one phone call (or even an email), which I just added to my calendar for tomorrow morning! (Grrrh!) :D

I will let you all know the outcome after I make the call.

Affectionately, Carole the Coward :D

PS For more about CP751,781, just google CaroleHammett and CP751,781 and it should bring up my past postings here on the subject.

Life is not measured by the number of breaths we take, but by the moments that take our breath away.--George Carlin

Posted

Hi, Barb.

Confession time: I didn't make the call yet.

There's also an email address. Tomorrow (now today) I may try to do that. If not, then Monday morning, I'll try to telephone again.

I don't know why I'm procrastinating on this one, but in the meantime, on Friday my Vitamin C iunfusion physician informed me that she couldn't feel any lymph node enlargement in my neck or subclavicle, both of which were areas of metastasis as far back as Dec '07.

She told me not to get my hopes up--that she wasn't declaring remission, but that at the very least, she believed the progression miust have slowed immenseley--if not halted (Remember, I am no longer tested because of being on hospice so feeling for enlargement of lymph nodes and liver (none), listening for lung air flow (clear) and blood draws for liver function levels (normal) are my only tests these days).

I think that's one of the reasons I'm reluctant to rock the boat (if it's not broke, don't fix it?).

Still, I should at least check out the CP 751,781, although in the meantime, I've become a strong proponent of large doses of oral Vitamin D and Vitamin C by infusion. :D

Affectionately,

Carole

Posted

Hi Carole,

Yes, testing the lymph node in the neck "by feel" is what the doctor did with Bill. Prior to Bill's taking the Tarceva, it could be seen with the naked eye - a pronounced bulge.

It is so shrunk that it cannot be felt. That node was like a "barometer" of sorts.

It was the first thing that went down for the count while he was first taking Alimta, and that lasted a very long, long while.

I know what you mean about rocking the boat. When something is showing evidence of working, it does make one think more than once.

However . . . what about having it in waiting in the wings, so to speak?

Barbara

Posted

Hi, Barbara.

I finally decided my procrastination telphone quotient was at 100% so tonight I sat down and emailed the Pfizer rep instead (a nice lengthy one that will hopefully give her all the information she might need to make an initial determination).

I still have the option of calling her, but if I do this way I can also refer her to my email.

Thanks for letting me knowabout Bill's neck lymph node. Definitely makes me feel better. :shock::D

My hospice doctor has since pointed out to me that it is also possible that the Prednisone is keeping lymph node inflammation down. I don't mind her having done so since I'd just as soon not end up with a false sense of courage (I prefer reality and always have). :(

Will keep you posted.

Affectionately,

Carole

Life is not measured by the number of breaths we take, but by the moments that take our breath away.--George Carlin

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