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trial phases

blackswampboy's picture
blackswampboy
Posts: 341
Joined: Jul 2012

just curious, can anybody shed light on the difference in phases?

I'm in a 5-year phase-3 erbitux trial--although I didn't catch the phase part until today. there's also a phase-2 erbitux trial going on.

thanks!

CivilMatt's picture
CivilMatt
Posts: 2927
Joined: May 2012

BSB,

 

A quick search revealed many studies and many phases.  I just completed skimming half a dozen articles about different phases.  The results have been better in H&N cancer treatments than in other types of cancer.

 

Good luck narrowing it down.  If you find good news let us know.  If you find bad news keep it to yourself (just kidding).  I can (maybe) take bad news (kidding again)

 

Good Luck!

 

Matt

blackswampboy's picture
blackswampboy
Posts: 341
Joined: Jul 2012

OK, found it. resume regularly scheduled programming, I'm just lazy.

 

Food and Drug Administration (FDA) categories (http://www.fda.gov/drugs/resourcesforyou/consumers/ucm143534.htm) for describing the clinical trial of a drug based on the study's characteristics, such as the objective and number of participants. There are five phases: 

Phase 0: Exploratory study involving very limited human exposure to the drug, with no therapeutic or diagnostic goals (for example, screening studies, microdose studies). 

Phase 1: Studies that are usually conducted with healthy volunteers and that emphasize safety. The goal is to find out what the drug's most frequent and serious adverse events are and, often, how the drug is metabolized and excreted. 

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition). For example, participants receiving the drug may be compared with similar participants receiving a different treatment, usually an inactive substance (called a placebo) or a different drug. Safety continues to be evaluated, and short-term adverse events are studied. 

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. 

Phase 4: Studies occurring after FDA has approved a drug for marketing. These including postmarket requirement and commitment studies that are required of or agreed to by the sponsor. These studies gather additional information about a drug's safety, efficacy, or optimal use. 

longtermsurvivor's picture
longtermsurvivor
Posts: 1788
Joined: Mar 2010

that's where you start to see the 1-800 call a lawyer ads on FOX.

luvofmylif
Posts: 344
Joined: Sep 2012

Just want to say you all crack me up with some of your responses. Just had to add that. It's one in the morning and smiling at some of the things I read on this site. Just feels good to be able to be back communicating with all.

 

luv4lacrosse's picture
luv4lacrosse
Posts: 1387
Joined: Jul 2010

Randomized Double Blind Study that is comparing the drug Erbitux manufactured in the USA VS the one manufactured in Europe. it is sponsored by Eli Lilly. is that US or Europe??

 

All I know is I get scanned every 6 weeks and at week 6 my tumors did not shrink, but changed in appearance, and at week 12 my tumors were no longer visible by CT Scan. I am getting Erbitux every Monday, and Carboplatin and 5FU every 3rd Monday. NOTE: I was taken off the 5FU 3 weeks ago due to severe side effects. My trial ends at the end of January, and if successfull, I will continue on Erbitux once weekly until it no longer is effective.

 

Mike

katenorwood
Posts: 1821
Joined: May 2012

BSB,

Thank you for bringing this topic up.  I have a few other people I know in trials for ADCC.  And yes there are different qualifications to get into trials and to stay in them.  It is heart  breaking when some have been pulled from the trials due to things not going the way they have to according to the standards set up.  (each is different.....and very specific to the trial)  But also there are the great stories where the trial actually kicked butt on mets that with traditional medication didn't work.  I don't know how I feel about how the whole thing works....but I will say again....people in trials are very brave....and I consider them pioneers in breaking ground in research.   Katie   

luv4lacrosse's picture
luv4lacrosse
Posts: 1387
Joined: Jul 2010

I may be way off base, but I am in a clinical trial that ends January 31st that has Eribtux every Monday and Carboplatin and 5 FU every 3rd Monday. I was taken off of the 5FU 3 weeks ago due to severe side effects. So far scans at week 12 showed all tuimors in right lower lobe and nodes in Mediastynum are no longer visible. if I make it to the end of January, I will be on Erbitux every Monday until I either have growth of existing tumors 20% or less and or any new growth.

Is this what you are on?? My trial has 200 participants with 20 of them at the place where I am being treated. (Siteman Cancer Center, Barnes Jewish Medical Center at Washington University in St. Louis.)

 

Mike

blackswampboy's picture
blackswampboy
Posts: 341
Joined: Jul 2012

best wishes with your treatment and the trial. may this all lead to better treatments down the road!

mine is comparing the effectiveness of erbitux & rads vs. cisplatin & rads. I'm happy to be a lab rat (every other month they hand me an iPad with hundreds of questions--rating pain, state of stools, state of my sex life...lol), but waiting five years to get conclusions is a long slog... I'm doing this from toledo, ohio. not sure how many are in the trial, only that half got erbitux & rads, and half got cisplatin & rads.

so yeah, just wondered what makes your trial phase 2, and mine phase 3. the summaries above from the FDA are kinda vague. maybe I don't really want to know.

douglas

corleone's picture
corleone
Posts: 156
Joined: Jul 2012

Hi Douglas,

Check this link, maybe it brings some further clarifications:

http://www.clinicalresearch.pitt.edu/docs/comparison_of_clinical_trial_phases.pdf

blackswampboy's picture
blackswampboy
Posts: 341
Joined: Jul 2012

thanks! that's way better.

thanks to all, appreciate your helpful responses.

luv4lacrosse's picture
luv4lacrosse
Posts: 1387
Joined: Jul 2010

I just know that is what my paperwork says. Just saw my doc earlier today before chemo and he says that out of the 20 he has on this study with me, I am the only one so far that has had a complete resolution of tumors. All were no longer visible on my 12 week scan.

 

Mike

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