I have just been approached by my oncologist to participate in a clinical
trial.The drug is FGN-1. Has anyone ever participated in one? This will be a
randomized,double-blind placebo controllled study.While it is exciting it is
still a bit scary. Can anyone offer any info. and/or feedback?
What phase is the clinical trial in? Phase I or II? A Phase I trial is for
determining at what dosage the drug should be given. A Phase II trial provides
information about how well the drug works, and what the side effects are.
Phase II trials usually enroll larger number of patients.
Have you considered all of the available options, including additional
chemotherapy, radiation therapy, and/or surgery (as the case may be) before
considering the clinical trial?
In my opinion, if you have widely metastatic or recurrent disease, it wouldn't
hurt to participate in a clinical trial. Often these offer avant-garde
treatments which won't be available anywhere else. On the other hand, though,
clinical trials being what they are, there wouldn't be much data available
regarding response rates, etc. You can ask the principal investigator (whose
phone number you can find through PDQ on National Cancer Institute's web site)
about the response rate of your particular disease to FGN-1.
You should also point out the most BASIC consideration in a clinical trial,
namely that Wanda would have a fifty-fifty probability of being given a
PLACEBO, i.e. NO TREATMENT other than the "placebo effect". Any patient
contemplating a clinical trial should consider that basic fact. The
experimental drug might work like Gangbusters, but if she gets the placebo,
she's not receiving the drug.
Wellesley Hills, MA
Why does this myth persist. It has been pointed out repeatedly that nobody with
active cancer receives a placebo in the sense that you are thinking of.
NEVER!!!!! The control group to which the new treatement is compared receive
the standard treatment which in this case would be the "placebo" group. There
are generally no control groups in phase I and II trials. The exception are
trials of preventive agents for those who are currently believed in remission.
The standard treatment for those in remission is no treatment so in this case a
placebo consisting of no treatment would be appropriate. I just checked the
cancernet clinical trial site for information on FGN-1 and learned that this is
not a treatment trial but rather a prevention trial. It is believed that
nonsteroidal anti-inflammatory drugs might act to prevent recurrence of some
types of cancer and this trial is of the anti-inflammatory Sulindac. This is
not a trial of a treatment for a person with known active cancer.
Below is some of the information from the cancernet site concerning this
particular trial. Additional information can be obtained from the site or by
contacting the principle investigator. Trial information is readily available
Phase II Randomized Study of Sulindac Sulfone (FGN-1) for Preventing the
Recurrence of Prostate Cancer (IDs: UCLA-HSPC-971104401, NCI-V98-1405,
I. Determine the efficacy of sulindac sulfone (FGN-1) in preventing the
recurrence of prostate cancer in patients who have undergone radical
prostatectomy and who have increasing PSA levels.
II. Determine the safety of FGN-1 in these patients.
PROTOCOL ENTRY CRITERIA:
Histologically proven prostate cancer, for which a radical prostatectomy was
Elevated PSA levels (0.4 ng/mL to 15 ng/mL)
At least 10% increase in PSA within last 4 months
No evidence of skeletal or other metastasis
This is a randomized, double blind, placebo controlled, multicenter study.
Patients are randomized to receive oral sulindac sulfone (FGN-1) or placebo 2
times daily for up to 12 months.
This is not true. Especially in an early-stage trial (such as Phase I), the
patients are given different doses of the drug, and the dosages are escalated
to determine the level of toxicity.
In a larger trial (Phase III), the experimental drug (e.g. biological response
modifier) is compared with standard regimen (e.g. chemotherapy that has been
proven to work). The patients are NOT left without any treatment.
My opinion regarding clinical trials is that, if your disease is at end stage,
and standard treatment is not stopping the progression of the disease, then it
couldn't hurt, and you could possibly benefit from, being a participant in a
Evidently it is not pointed out often enough, because I'm not totally
illiterate, and it has never been pointed out to me before. Thanks for
educating me. Glad to know that it isn't as bad as I had been led to
believe, presumably by some who were also victims of the "myth".
However, I suppose it's still a good question for the patient to ask
very specifically, before signing up.
No need to ask. Before you are entered into a formal trial, you
are required to sign several consent forms. I was given a lot of
information and copies of the blank forms several days before I
was to return for the "signing". Before offering the real forms
for my signature the hospital/physician took special care to
explain the entire procedure, what drugs were involved, which of
them I might get, the potential side-effects, and the fact that I
could leave the trial any time I wished.
As was said, the trial consisted of a new drug combination vs
what was then considered standard chemotherapy. I happened to end
up on the new combination which apparently worked wonderfully in