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Celebrex trial

vinaykumar
Posts: 66
Joined: Dec 2012

Anyone here who is going to be a part of this trial?

 

 

http://clinicaltrials.gov/ct2/show/NCT01729923?term=ADAPT+colon&rank=2

pete43lost_at_sea's picture
pete43lost_at_sea
Posts: 3915
Joined: Nov 2010

i have been on celebrex for so long now.

that mainstream centers are doing these studies at last vindication of my research and judgement.

I am not on this trial, but have been on my own personalised trial.

I just wanted to copy secondary trial goals

Hugs,

Pete

ps I have to go now and get some ozone.

Primary Outcome Measures:
  • Rate of CR, assessed according to CEA and CA 19-9 measurements and Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 [ Time Frame: 3 years ] [ Designated as safety issue: No ]

 

Secondary Outcome Measures:
  • Relapse free survival in patients achieving CR [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Estimated using the Kaplan-Meier method based on the ITT population starting from the time of induction chemotherapy initiation.
  • PFS as defined by true disease progression (new sites of disease) [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Estimated using the Kaplan-Meier method based on the ITT population starting from the time of induction chemotherapy initiation.
  • Overall survival [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Estimated using the Kaplan-Meier method based on the ITT population starting from the time of induction chemotherapy initiation.
  • Best overall response rate, defined using RECIST 1.1 [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    The relationship between K-ras mutation, resection, and radiation and response to ADAPT therapy will be evaluated using Chi-squared analysis and Cox regression analysis.
  • K-ras mutation status [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    The relationship between K-ras mutation, resection, and radiation and response to ADAPT therapy will be evaluated using Chi-squared analysis and Cox regression analysis.
  • Quality of life (QOL), assessed using the M.D. Anderson Symptom Inventory (MDASI) [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Group differences in QOL will be estimated, with repeated measures used to improve precision of estimates.
  • Adverse events defined as any condition that appears or worsens after the subject is enrolled in an investigational study, graded by numerical score according to the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) version 4.0 [ Time Frame: Up to 30 days after completion of study treatment ] [ Designated as safety issue: Yes ]
    The number and percent of subjects reporting adverse events coded as grade 3 or greater will be summarized by treatment group and strata. Listings will be provided for all on-study deaths and adverse events that lead to withdrawal from study. Narratives of all serious adverse events and deaths on-study will be provided.
Lovekitties's picture
Lovekitties
Posts: 2926
Joined: Jan 2010

This study is not yet open for participant recruitment.

Verified November 2012 by Fred Hutchinson Cancer Research Center
vinaykumar
Posts: 66
Joined: Dec 2012

thanks for pointing that out marie :) , may be i asked it wrong....i wanted to find out if anyone is going to be a part of this trial? OR has anyone taken celebrex based treatment from Dr Lin? ( one of the oncs heading this trial)

jimc43
Posts: 5
Joined: Jan 2013

Hi Vinaykumar, there are a few folks at ColonClub that are treated by Dr. Lin.  You can put     Lin     in the search feature.  Also, username    Maia    (again at ColonClub) posts often about her friend who is being treated by Dr. Lin.  Maia has posted many interesting articles related to the xeloda/celecoxib combination.  You might search    celecoxib    among Maia's posts.  My wife started a xeloda/celebrex combination in Dec/2012 to address several small nodules in her lungs.  First follow-up scan will be next week.  You may know that in Dr. Lin's upcoming trial, Celebrex will be dosed at 200mg twice a day and Xeloda will be dosed at 1000mg/m2(body surface area) twice a day.

luvinlife2
Posts: 172
Joined: Jul 2012

400mg/day is a high dose and I'm surprised that Dr. Lin would ask patients to take the risks associated with that dose in a clinical trial.  In the TV announcements about the Canadian class action suit against the makers of Celebrex the heart problems were associated with 400mg doses and higher.

http://www.webmd.com/heart-disease/news/20080401/celebrex-use-less-to-lessen-heart-risk

200mg twice a day doubles the risk of heart attacks, other heart problems, strokes or cardiovascular disease death.  

 

tanstaafl's picture
tanstaafl
Posts: 956
Joined: Oct 2010

The absolute risk is considered much lower.  If 200-400 mg celecoxib adds 1-2% per year mortality risk vs, say, 10-15% per year mortality reduction from advanced colon cancer, it is a trade off.   LEF recommended 800 mg per day 3 years ago when we started.  We chose natural COX2 inhibitors with their own extra targets for 34 months.

Kathy, I've avoided celecoxib in part because I have a friend whose wife was apparently a Vioxx victim after several (5?) years of taking that.   A few weeks ago my wife started taking 400mg per day, in addition to everything else.

luvinlife2
Posts: 172
Joined: Jul 2012

but I would be interested to know where the 400mg/day comes from and why wouldn't one start with a lower dose first?  For those of us who are still taking chemo such as avastin or even ALA iv's both treatments that can raise blood pressure I would think a lower dose of celebrex would be safer, at least until it can be determined that there are no negative effects.

jimc43
Posts: 5
Joined: Jan 2013

Hi luvinlife, thanks for the webmd article.  Really interesting that 200mg twice a day doubled serious cardiovascular events but 400mg once a day only increased them by 10%.  Would love to hear some theory on that.

I will echo Tanstaafl with regard to relative risks.  The possibility of control of what was a very advanced stage 4 disease at initial diagnosis 20 months ago with xeloda and celebrex (and many supplements) as opposed to more Folfiri or Folfox is well worth the risk to us.  I've looked at a lot of studies regarding Celebrex and my remembrance is that efficacy may be dose-dependent.

Interesting, this huge ongoing study (2500 planned participants) for stage 3 folks testing adjuvant folfox with or with celebrex (AND for 3 months or 6 months) is using a 400mg per day dosage:

http://clinicaltrials.gov/ct2/show/NCT01150045

 

 

 

 

 

annalexandria's picture
annalexandria
Posts: 2193
Joined: Oct 2011

but he didn't suggest using Celebrex, and my own doc (who recommended I see Lin) wasn't comfortable with prescribing Celebrex when I asked him about it.  I did end up taking it for awhile, in an effort to deal with joint pain, but it made me very sick.  Bad cramping and diarrhea.  So just be aware that like all drugs it has significant side effects, and if you have a compromised digestive system like I do, it may be difficult to take.  AA

pete43lost_at_sea's picture
pete43lost_at_sea
Posts: 3915
Joined: Nov 2010

i have been on celebrex for along time, maybe the probiotic maf 314 gcmaf yogurt is buying my gut some protection. I was just wondering why i have been blessed with a healthy gut, it may be the probiotics twice per day after meals.

hugs,

pete

renw's picture
renw
Posts: 282
Joined: Jan 2013

Not part of the trial, but been on Celebrex for a week now. Won another battle with my oncologist and finally got him to prescribe it with cimetidine. Working on Metfirmin next, but he is resisting. I'll push him more next week. :)

pete43lost_at_sea's picture
pete43lost_at_sea
Posts: 3915
Joined: Nov 2010

to write the scripts, but i was not on chemo, so the onc was more passive.

hugs,

pete

ps becareful you don't want to stress your onc to much, they might get cancer

renw's picture
renw
Posts: 282
Joined: Jan 2013

Sometimes I think getting cancer is exactly what some oncologists need. :)

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