Dad at MD Anderson for evaluation of Phase III Clinical Trial

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unclaw2002
unclaw2002 Member Posts: 599
edited March 2014 in Esophageal Cancer #1
I wanted to let everyone know that my dad, he just had his 79th birthday is at MD Anderson and being evaluated for participation in a Phase III Clinical Trial. My Dad was initally Stage III, T3,N2,MO at the gastric junction and then had the cancer spread to his liver with tumors in both lobes. The chemo was not successful and the tumor is once again growing in his esophagous and a new tumor in the liver. He had been given 5FU but he did not tolerate it very well and had to stop because of his blood counts.

The doctors said there wasn't much to do, perhaps add another chemo agent (that didn't make sense to me since he wasn't tolerating one agent) or to look into a clinical trial because surgery, embolization, sphere therapy wasn't an option for him. So he found this Phase III trial and here we are.

He has gotten past the initial screens and next is blood work and scan evaluation (he had them today). From everything the doctor has told him it looks like he will be accepted into the trial. It will involve an infusion every other week (out of every 3 patients two will get the drug and 1 won't). This trial is moving toward FDA approval of this drug for treatment of Stage IV EC to arrest the spread of the cancer. I haven't seen the results of the Phase II trials because they don't have to release those until the study is complete but apparently the goal of the treatment is to increase life expectency from months to an average of 40 months. The doctors told my father that they are very encouraged by the results of the study (this Phase III trial has been going on for 2 years). Another thing they said is if they don't see improvement or stabilization then they will stop the treatments. Imclone is the company who developed this drug and the trials are going on at over 90 sites around the world. This does sound interesting and promising.

The Phase III Trial is at MD Anderson in Houston. It is A Phase 3, Randomized, Double-Blinded Study of IMC-1121B and Best Supportive Care (BSC) Versus Placebo and BSC in the Treatment of Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Following Disease Progression on First-Line Platinum- or Fluoropyrimidine-Containing Combination Therapy (IMCL CP12-0715). The NCT number is 00917384 and requires a bi-weekly infusion of IMC-1121B plus Best Supportive Care. http://clinicaltrials.gov/ct2/show/NCT00917384 and MD Anderson listing at http://utm-ext01a.mdacc.tmc.edu/dept/prot/clinicaltrialswp.nsf/Index/2009-0231. (as always cut and paste in your browser because this site doesn't support hyperlinks).

I am a little conflicted because on the one hand my dad hasn't had chemo since October 5th and is starting to look and feel better and stronger and I am not sure that subjecting him to this new drug is worth it, or worse yet if he gets the placibo. He has been enjoying himself the last month or so eating what he wants and free from pain. But then the option of 40 months verses 6 is alot of time. At the end of the day it is his decision and he wants to keep on trying to beat back this beast and he has regained his strength. We did discuss the stent and J-tube issue. No determination on that at this point. He will see the doctor who is heading up the clinical trial again on Monday and if all goes as planned he will have his first treatment the following Tuesday.

Thanks for all your prayers and support and if anyone has any questions about the clinical trial let me know and I will be happy to see if I can help answer any questions. Depending on the schedule when we are in New Orleans at Christmas we may be able to take him to Houston for his treatment while we are there so I can check out the deal :) I am glad we are going to be there for Christmas.

Cindy

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  • unclaw2002
    unclaw2002 Member Posts: 599
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    unknown said:

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    William and Loretta,
    Thank

    William and Loretta,

    Thank you for the encouragement. Dad was accepted into the clinical trial he will receive his first infusion treatment tomorrow and then have to travel to Houston every two weeks for the treatments. The tumor grew in the liver from 2.5 cm to 5.4 in just over 3 months but then he hasn't had any chemo for the last two.

    This new drug attackes the blood supply to the tumors and causes them to die. The clinical trial went straight from a Stage I trial to a Stage III trial because the results were so promising for EC patients. The trial has been going on since Oct. of 2009. I hope dad is one of the lucky one who actually gets the drug. I am praying and we will see what happens.

    The good news is that he will be under the treatment of the doctors at MD Anderson now.

    Best to everyone,

    Cindy
  • oriontj
    oriontj Member Posts: 375
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    William and Loretta,
    Thank

    William and Loretta,

    Thank you for the encouragement. Dad was accepted into the clinical trial he will receive his first infusion treatment tomorrow and then have to travel to Houston every two weeks for the treatments. The tumor grew in the liver from 2.5 cm to 5.4 in just over 3 months but then he hasn't had any chemo for the last two.

    This new drug attackes the blood supply to the tumors and causes them to die. The clinical trial went straight from a Stage I trial to a Stage III trial because the results were so promising for EC patients. The trial has been going on since Oct. of 2009. I hope dad is one of the lucky one who actually gets the drug. I am praying and we will see what happens.

    The good news is that he will be under the treatment of the doctors at MD Anderson now.

    Best to everyone,

    Cindy

    Will you know
    if he has the drug? We knew that my husband was in the clinical trial arm that had the Erbitux...his oncologist told he was and of course he had the drug during his chemo sessions. I pray he will get the drug very hard...

    orion
  • unclaw2002
    unclaw2002 Member Posts: 599
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    oriontj said:

    Will you know
    if he has the drug? We knew that my husband was in the clinical trial arm that had the Erbitux...his oncologist told he was and of course he had the drug during his chemo sessions. I pray he will get the drug very hard...

    orion

    No it is a double blind
    No it is a double blind study. For every three patients two will get the drug and one won't. Of course if the tumors shrink and he gets better or stabilizes then we can assume he is receiving the drug and responding to the treatment. I assume at some point we will be told but at this preliminary entry into the study we are not allowed to know --- indeed the doctors and nurses don't know either - the drugs are shipped in from ImClone specifically for each patient.

    Thank you for your prayers. My dad had tried to get into the Erbitux trial but couldn't because he wasn't eligible to take the Cisplatin because of his diabeties. That seems to be a very promising drug as well.
  • sal314
    sal314 Member Posts: 599 Member
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    Thanks for Posting Information!
    Sounds VERY interesting Cindy! You're dad's situation is very similar to my dad's! I'm gonna email them the info. about the study. I can only pray they will decide to call and look into it!

    Wishing all the best to you and your dad.

    Blessings,
    Sally
  • oriontj
    oriontj Member Posts: 375
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    No it is a double blind
    No it is a double blind study. For every three patients two will get the drug and one won't. Of course if the tumors shrink and he gets better or stabilizes then we can assume he is receiving the drug and responding to the treatment. I assume at some point we will be told but at this preliminary entry into the study we are not allowed to know --- indeed the doctors and nurses don't know either - the drugs are shipped in from ImClone specifically for each patient.

    Thank you for your prayers. My dad had tried to get into the Erbitux trial but couldn't because he wasn't eligible to take the Cisplatin because of his diabeties. That seems to be a very promising drug as well.

    My husband is diabetic and had
    Cisplatin...and had no trouble with it...I sure don't understand the "ins and outs" of clinical trials....

    I prayed very hard for everyone of the board this evening at Mass....Holy Day of Obligation Vigil...there's a special time for prayers in our hearts and one of mine is everyone on the board touched by EC...

    More prayers for your father...I sincerely pray he will receive the drug...

    jan