Kevin update and treatment plan

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Sue Mullen - 17 Sep 2009 20:12 GMT

As you can see below Kevin's PSA continued rising, 15.0 on 8/12 to 20.8
on the 8/19 blood draw.

On 8/24 we saw his medical oncologist and after some discussion Kevin
signed up to enter the Abiraterone phase 3 trial. We then sat down with
the Clinical Research Coordinator, gave her further information and she
said she would be in touch with the schedule of tests required. The
following Monday Kevin got a call from the medical oncologist's nurse
practitioner(the med onc was on vacation) saying that Kevin could not go
into the Abiraterone trial because of the radiation he had for his
spinal mets. We were very disappointed, but had to move on to what to do
next.

The new game plan was to start taking 5mg prednisone twice a day, do a
bone scan and a CT of the pelvis/abdominal area and see the med. onc.
again on Sept 14th with the results of the scans.

The results of the tests showed "widespread metastatic disease to bone
which is significantly worse then the previous study" which was just a
little more then 3 months previous. The report did say that the lesions
on the lower thoracic spine, where Kevin had the radiation treatments,
are less intense.

On Monday we saw the med. onc. as planned, he explained the test results
to us and we talked about what to do next. The plan is for Kevin to
have a CT chest scan, have another PSA test next week and see the med.
onc. again on Sept 29th. If Kevin's psa has started to go down with the
Prednisone, he will just continue with that for now. If his psa doesn't
go down, he will start getting doxetaxol treatments every 3 weeks and
if needed it will start the day he sees the med onc.

The reason the doctor is going for chemo as a next step instead of
Ketoconazole, is that he is thinking of the future. He said that the
MDV3100 trial is for men who have failed chemo and is very promising. If
you have already taken Ketoconazole, they will not take you into the
trial. He also told us not to give up on Abiraterone, once it is FDA
approved it is possible Kevin could take it.

Kevin is having some mild pain in his lower back from the new lesions,
but not enough that he needs any meds for it. This is also being
watched and we talked about maybe doing some radiation again. At least
the med onc knows Kevin's rad onc for 20 years and he says if more
radiation is needed Kevin should use the one he knows and who knows him
already.

We also talked about Zometa and that is still planned for the end of
Oct. which is 3 months after Kevin's last dental surgery.

I think that is about all for now, this saga will be continued when we
see the med. onc. on Sept 29th.

sue (and Kevin)

10/05 2.2
8/07 4.1
12/07 7.9
8/08 0.1
2/2/09 4.1
5/5/09 14.5
5/11/09 19.0
6/15/09 10.3
8/12/09 15.0
8/19/09 20.8

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Steve Kramer - 18 Sep 2009 12:04 GMT

I'm sure you (pl) are disappointed, Sue. But, it sounds like you have a
good onc with an eye toward future trials.

You are providing us with great insight as well. I will surely remember in
the future how some treatments can nullify one's qualifications for trials.

: As you can see below Kevin's PSA continued rising, 15.0 on 8/12 to 20.8
: on the 8/19 blood draw.
[quoted text clipped - 59 lines]
: 8/12/09 15.0
: 8/19/09 20.8

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Sue Mullen - 18 Sep 2009 17:00 GMT

> I'm sure you (pl) are disappointed, Sue. But, it sounds like you have a
> good onc with an eye toward future trials.

We were disappointed, but the med onc said not to rule out Abiraterone
for the future. The trial sounds like it would be easier then chemo, but
we like very much that the onc. is looking towards the future for Kevin.
We both feel we picked a great onc. and we thank everyone who helped us
make this decision.

> You are providing us with great insight as well. I will surely remember in
> the future how some treatments can nullify one's qualifications for trials.

Thanks, I have learned so much here in the past 1 1/2 years and am glad
to share any information we get.

Question? I have some comments/info to share about the Abiraterone Phase
3 trial. Do you think a new thread would be best or should I go back and
add my comments/info to the individual posts already made.

sue

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Steve Kramer - 21 Sep 2009 00:31 GMT

: Question? I have some comments/info to share about the Abiraterone Phase
: 3 trial. Do you think a new thread would be best or should I go back and
: add my comments/info to the individual posts already made.

There are no purists here. Do it however you want.

I just changed the Subject line. That should help.

Signature

PSA 16 10/17/2000 @ 46
Biopsy 11/01/2000 G7 (3+4), T2c
RRP 12/15/2000 G7 (3+4), T3cN0M0 Neg margins
PSA <.1 <.1 <.1 .27 .37 .75 PSAD 0.19 years
EBRT 05-07/2002 @ 47
PSA .34 .22 .15 .21 .32 PSAD .056 years
Lupron 07/03 (1 mo) 8/03 and every 4 months there after
PSA .07 .05 .06 .09 .08 .132 .145 PSAD 1.4 years
Casodex added daily 07/06
PSA undetectable since; last checked on 06/04/09
Illegitimati non carborundum

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J - 21 Sep 2009 21:25 GMT

> "Sue Mullen" <kjmullen@comcast.net> wrote in message
> : Question? I have some comments/info to share about the Abiraterone Phase
[quoted text clipped - 4 lines]
>
> I just changed the Subject line. That should help.

http://clinicaltrials.gov/ct2/show/NCT00638690

Abiraterone Acetate in Castration-Resistant Prostate Cancer Previously Treated
With Docetaxel-Based Chemotherapy
This study is ongoing, but not recruiting participants.
First Received: March 13, 2008 Last Updated: May 11, 2009 History of
Changes
Sponsored by: Cougar Biotechnology, Inc.
Information provided by: Cougar Biotechnology, Inc.
ClinicalTrials.gov Identifier: NCT00638690
Purpose

This is a phase 3 study to compare the clinical benefit of abiraterone acetate
plus prednisone with placebo plus prednisone in patients with metastatic
castration-resistant prostate cancer (CRPC) who have failed one or two
chemotherapy regimens. At least one of the previous chemotherapies must have
contained docetaxel

Condition Intervention Phase
Metastatic Castration-Resistant Prostate Cancer
Drug: placebo plus prednisone/prednisolone
Drug: abiraterone acetate plus prednisone/prednisolone
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver,
Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment,
Safety/Efficacy Study
Official Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study
of Abiraterone Acetate (CB7630) Plus Prednisone in Patients With Metastatic
Castration-Resistant Prostate Cancer Who Have Failed Docetaxel-Based
Chemotherapy

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer
Drug Information available for: Prednisolone Prednisolone acetate Prednisone
Depo-medrol Medrol veriderm Methylprednisolone Docetaxel CB 7630 Abiraterone
Prednisolone sodium phosphate Prednisolone Sodium Succinate Methylprednisolone
Sodium Succinate Methylprednisolone hemisuccinate 6-Methylprednisolone
U.S. FDA Resources

Further study details as provided by Cougar Biotechnology, Inc.:

Primary Outcome Measures:
* Overall Survival [ Time Frame: During the Study ] [ Designated as safety
issue: No ]

Secondary Outcome Measures:
* Proportion of patients achieving a PSA decline >/= 50% according to
Prostate Specific Antigen Working Group (PSAWG) criteria [ Time Frame: During
Study Treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 1158
Study Start Date: April 2008
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for
primary outcome measure)
Arms Assigned Interventions
1: Experimental
abiraterone acetate plus prednisone/prednisolone
Drug: abiraterone acetate plus prednisone/prednisolone
1000mg Daily/5mg Twice Daily
2: Placebo Comparator
placebo plus prednisone/prednisolone
Drug: placebo plus prednisone/prednisolone
1000mg Daily/5mg Twice Daily

Eligibility

Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Male
Accepts Healthy Volunteers: No

Criteria
Major Inclusion Criteria:

* Metastatic Castration-Resistant Prostate Cancer
* Progression after one or two prior cytotoxic chemotherapies. At least
one chemotherapy must have contained docetaxel
* ECOG Performance Status less than/ equal to 2
* Medical or surgical castration with testosterone less than 50 ng/dL
* Adequate bone marrow, hepatic and renal function
* Potassium greater than/ equal to 3.5 mmol/L
* Able to swallow the study drug whole as a tablet
* Informed Consent

Major Exclusion Criteria:

* More than two prior cytotoxic chemotherapy regimens
* Prior Ketoconazole for prostate cancer
* Prior Abiraterone acetate or other CYP17 inhibitor or investigational
agents targeting the androgen receptor for prostate cancer
* Uncontrolled hypertension
* Active or symptomatic viral hepatitis or chronic liver disease
* History of pituitary or adrenal dysfunction
* Clinically significant heart disease
* Other malignancy
* Known brain metastasis
* GI disorder affecting absorption
* Not willing to use contraception

Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00638690

Show 152 Study Locations
Sponsors and Collaborators
Cougar Biotechnology, Inc.
Investigators
Study Chair: Howard I Scher, MD Memorial Sloan-Kettering Cancer Center
Study Chair: JS de Bono, MD FRCP PhD ICR/Royal Marsden Hospital
More Information

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Sue Mullen - 22 Sep 2009 01:16 GMT

> : Question? I have some comments/info to share about the Abiraterone Phase
> : 3 trial. Do you think a new thread would be best or should I go back and
[quoted text clipped - 3 lines]
>
> I just changed the Subject line. That should help.

Thanks, I have been too busy and too worn out to get to this yet. If
tomorrow is a quieter day, I will post my comments about Abirateone.

sue

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Steve Kramer - 22 Sep 2009 14:45 GMT

: > : Question? I have some comments/info to share about the Abiraterone Phase
: > : 3 trial. Do you think a new thread would be best or should I go back and
[quoted text clipped - 8 lines]
:
: sue

No deadlines here either!! :-)

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Sue Mullen - 23 Sep 2009 20:18 GMT

Some random information that may or may not of been posted before.

The article posted by "J" says that the phase 3 trial is closed, but as
of two weeks ago it was still open at Fox Chase Cancer Center in
Philadelphia. Maybe the phase 3 trial is closed in the UK or maybe only
in some hospitals?

The Abiraterone phase 3 clinical trial is a placebo controlled study of
Abiraterone plus Prednisone. Every man will take 4 tablets of
abiraterone or 4 tablets of placebo by mouth, the placebo looks just
like the real thing and in addition each person will take prednisone 5mg
twice daily.

This is a quote from the study papers we got: "prednisone is commonly
prescribed to people with castration-resistant prostate cancer". This
means that even if you don't get the real Abiraterone, your cancer is
still being treated.

In order to get into the trial you have to stop taking Casodex. Since
Kevin had been taking Casodex a short time, he would only of had to be
off it for two weeks, but after longer use you have to be off it longer.

At Fox Chase Cancer Center the testing would of been done on two
separate days. The only reason for the second day is that the dye for
one of the tests can't be used the same time as the dye for another
test. The testing consists of blood work, a MUGA scan, CT scan of the
chest, abdomen and pelvis and a bone scan.

For the first three months you are in the trial, you have to go to the
clinic/hospital twice a month, after that it is about once a month.
Every two months they do scans to check your progress. If one time the
scans show progression of your cancer, they ask that you continue for
another cycle. If the second set of scans is not good, you are out of
the trial. You are of course free to quit the trial at any time, but if
you do, you need to taper off the prednisone.

In the article that "J" posted it lists major exclusions criteria, but
it leaves out the reason Kevin could not go into the trial. If you have
had radiation for your metastases you will not be able to enter the trial.

I still have the papers we got with the consent form, so if anyone has
questions I will be glad to look for the answers if they are there.

sue

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