Sep 24, 2014

OHSU led Prostate Cancer Clinical Trial results in FDA approval

This is a reprint of an article from the  Portland Oregonian, written by Nick Budnick

A prostate cancer drug spearheaded by Oregon researchers has received federal approval based on studies showing it prolongs life without chemotherapy.

Enzalutimide was approved for prostate cancer under the name Xtandi® two years ago, but was authorized only for patients who were already on chemotherapy.

Now, the Food and Drug Administration has approved the drug for a new group of patients based on trials overseen by Knight Cancer Institute at Oregon Health & Science University.
The drug slows the disease, it doesn't cure it. However, the pill's expanded approval is significant for prostate cancer sufferers, many of whom never enter chemotherapy. Some don't care to undergo chemo's debilitating side effects, and some older patients are too vulnerable to even try.

The study found that the average treatment time on the daily pill – meaning until chemotherapy was deemed medically appropriate -- was 16 months, said Tomasz Beer, the institute's deputy director who oversaw the trials. Subsequent data suggests the period may be as long as 19 months.

In contrast, the average time before chemotherapy was required for people on the placebo pill was about four months.

"It's buying you close to a year and a half where your cancer is controlled by a pill," Beer said.

The drug also lowered the likelihood of death by 30 percent at any one time, according to trial results. The study was conducted on more than 1,700 patients in numerous countries including the United States, Canada, Europe, Australia, Russia, and Japan.

Treatment costs are about $7,500 a month.

Post Text Here
To put a smile on your face see Larry's latest cartoon.
To learn more about clinical trials, take a look at our book.

(c) 2012 Tom Beer and Larry Axmaker

Aug 31, 2014

Americans avoid clinical trials—why?


On this blog site we have written several articles about experimental medicine, new drug approval by the FDA, and the low adult participation rate in cancer clinical trials—in the 3% to 5% range. A recent online survey of more than 1000 adult volunteers produced some interesting answers to questions about clinical trials—attitudes, beliefs, fears, costs, and individual needs. 

The poll was commissioned by Research America, the Association of Clinical Research Organizations, the Clinical Research Forum, the Friends of the National Library of Medicine and the Clinical Trials Transformation Initiative. The results were published by PharmaLive.com.

How the 1006 online volunteers responded:
  • 72% said they would likely participate if their doctor recommended it (26% very likely, 46% somewhat likely)
  • 70% said their physicians had never discussed medical research with them
  • The Internet was the most common source of clinical trial information (53%)
  • 51% cited a lack of trust in the process for not participating
  • 53% said a lack of information kept them from pursuing clinical trials
  • 35% were concerned with compensation for participation
  • 27% cited privacy concerns
  • 69% would consider the reputation of the doctor or medical center conducting the trial
  • 37% admire others who participate
  • 73% want to advance medical research

What does all of this mean? A recurring theme is that people don’t have enough information and particularly don’t get enough information from their doctors. There are probably other factors that lead to final decisions. Remember, whatever the numbers in this survey, still only 3% to 5% of adults with cancer ever participate in a clinical trial.

Want to see the Research America Clinical Research Poll questions and results for yourself? How would you respond?
  
Post Text Here
To put a smile on your face see Larry's latest cartoon.
To learn more about clinical trials, take a look at our book.

(c) 2012 Tom Beer and Larry Axmaker

Aug 18, 2014

Back to basics



Since starting this Cancer Clinical Trials blog in 2011, we have covered a lot of materials, provided links, and talked about the latest experimental drugs. We believe that every once-in-a-while it is a good idea to go back and review clinical trial basics.

What is a clinical trial?
Clinical trials are highly organized and complex experiments to test and compare new therapies in human volunteers who may or may not have cancer. Promising treatments go through a series of tests to make sure they are safe, effective, and have minimal side effects. Testing in humans is the only way to find this information. All the Standard Cancer Therapies currently in use were developed and proven effective in clinical trials. Then they were approved for general use by the FDA (U.S. Food and Drug Administration).

Why would you want to participate in a clinical trial?
You may consider joining a clinical trial if no appropriate standard therapy is available; the current standard treatment leaves room for improvement; or because you don’t need treatment right away because your cancer is slow-growing and you would like to try something new.

Many new ideas are being evaluated in clinical trials today--for a broad variety of cancers. Cancer treatment has advanced and improved rapidly in recent years.There are more cancer survivors than ever before. But many experimental cancer drugs and treatments have not yet been tested in humans because there are not enough clinical trial volunteers.

We will continue to provide a variety of information to increase your understanding and maybe even help you make personal health decisions. We welcome your questions and comments. 


To put a smile on your face see Larry's latest cartoon.
To learn more about clinical trials, take a look at our book.

(c) 2012 Tom Beer and Larry Axmaker

Jul 23, 2014

FDA approves new lung cancer drug



The lung cancer drug erlotinib (Tarceva) treats a certain type of non-small cell lung cancer. 10% to 30% of lung cancer cases fall into this category. In a randomized phase III clinical trial, erlotinib, in tablet form, was compared to the current best treatment; platinum-based doublet chemotherapy.

The trial measured and compared progression free survival (PFS) and overall survival (OS). The experimental drug performed significantly better in both measures. The median age of participants was 65, more than two out of three were women, and most had never smoked. There was tumor shrinkage in 65% of those taking erlotinib and 16% of those receiving chemotherapy.

This is another example of the power and efficiency of the clinical trials process. As a result of a clinical trial a new and improved treatment is now available.

Erlotinib is sold by Genentech as Tarceva. You can find more information on their website.


To put a smile on your face see Larry's latest cartoon.
To learn more about clinical trials, take a look at our book.

(c) 2012 Tom Beer and Larry Axmaker

Feb 7, 2014

Enzalutamide shown to extend survival in prostate cancer

A video summary of my presentation at GU Cancers Symposium in San Francisco in the last days of January 2014.



 From http://ecancer.org.  To go the ecancer site, click here

To put a smile on your face see Larry's latest cartoon.
To learn more about clinical trials, take a look at our book.

(c) 2012 Tom Beer and Larry Axmaker

Jan 1, 2014

Experimental drug may stop resistance to cancer drugs


A major problem faced by many cancer patients is that drugs that are initially successful in managing their cancer lose their effectiveness over time. Sometimes there are other drugs that will work just as well and sometimes there are not.

Pro Tide NUC-1031, an experimental drug, has shown early success in stopping drug resistance in some patients with pancreatic, lung, breast, ovarian, and colorectal cancers. In a small Phase I study conducted in London U.K., 11 cancer patients were given varied doses of NUC-1031. 6 of the 11 patients showed positive results for as long as 24 weeks. Phase II and III trials are scheduled for 2014.

The initial study was small and there is no guarantee that larger trials will get the same results. There are other drugs designed to stop resistance to cancer drugs but their success rate is only in the 5% to 10% range.

Why could this be important for you? If you have had to change medications over and over because they lose effectiveness, NUC-1031 may extend the effectiveness of your meds.


To put a smile on your face see Larry's latest cartoon.
To learn more about clinical trials, take a look at our book.

(c) 2012 Tom Beer and Larry Axmaker

Jun 5, 2013

Can the immune system remember?

The study we discuss here is not "ready for prime time" but it does report some exciting findings that suggest that immunologic therapy for cancer can produce long term immune memory



To put a smile on your face see Larry's latest cartoon.
To learn more about clinical trials, take a look at our book.

(c) 2012 Tom Beer and Larry Axmaker

May 3, 2013

Larry and Tom interviewed: prostate cancer, clinical trials, and our book

We were interviewed by the blog JoinClinicalTrials.com a while back.  Here we share the interview with you:
1. How did the two of you become colleagues/friends and what was the inspiration behind your blog? 
We met in the prostate cancer clinic as patient and physician and forged a friendship over the years.  The blog, along with the book was inspired by a strong desire to share knowledge about clinical trials with people who are living with cancer and who are called upon to make decisions about their cancer care. 

 2.  You are co-authors of the book Cancer Clinical Trials. Please tell us about it and what prompted you to write a book about clinical trials?
For 15 years now I have been deeply involved in clinical trials.  I have talked to thousands of cancer patients about hundreds of clinical trials.  Despite the fact that we spend a lot of time with each potential participant, I frequently had the nagging feeling that in the course of a clinic visit, or even several, we could never quite do a good enough job sharing all the knowledge I wanted to share with my patients.  The book was the only way to get this done.

 3. Dr. Beer, could you please address some of the common misconceptions and fears that people have in regards to clinical trials?
Well, there are many, and we cite examples throughout the book of misconceptions we have run across.  I think the first thing people worry about is that they will get a placebo and not a real drug.  We talk a lot about the way placebos are used in research in the book.  I think that is the area where there are the most misconceptions. 
There are many other areas.  For example, many people think that clinical trials are only appropriate when all other options have been exhausted.  That is not true at all.  Clinical trials are seeking to improve care across the entire spectrum of the disease and may be worthy of consideration at various points in the battle with cancer.

 4.  (Dr. Beer) Many people think that clinical trials are an option only after they have tried every other treatment for their cancer; however, is that really the case? Is it possible for patients to participate in trials in different stages of their disease?
No question about it.  Clinical trials seek to improve care in all situations including front line care.  The trials may be different in patients that have good standard treatment options.  For example, the standard treatment may be included for all patients and the new drug is added to it. 
But without clinical trials that test even the most fundamental cancer treatments, we would not have made the advances we have.  For example, breast cancer is often treated with surgery that removes only the cancerous lump and spares the breast.  Clinical trials that proved this was a sound approach are responsible for women being able to keep their bodies intact through cancer treatment.

More of our interview in the next post.

To put a smile on your face see Larry's latest cartoon.
To learn more about clinical trials, take a look at our book.
(c) 2013 Tom Beer and Larry Axmaker

Apr 25, 2013

One new type of medication may treat many cancers

Wouldn't it be great if there were medications that would treat many types of cancer? Well, they might be on the horizon.

For the first time ever, three different pharmaceutical companies; Merck, Roche, and Sanofi, are testing drugs that, hopefully, will restore a mechanism that normally makes badly damaged cells self-destruct. This is the norm in our bodies. Remember that cancer cells are dangerous because they do not self-destruct.

A protein molecule known as p53 normally allows damaged cells in the body to self-destruct but, in about half of all cancers, it is disabled when another protein molecule found in cancer cells, MDM2, attaches to it. This stops cancer cell death and allows the cancer to keep growing. Researchers have long hoped to find a way to restart p53.

Recent research has found ways to break the two proteins apart, allowing the p53 gene to once again trigger the death of damaged (cancerous) cells. Testing with mice has been quite successful.

It doesn't seem to matter whether the cancer is identified as breast, colon, lung, prostate, cervical, or one of many other cancers. The process is the same. Current trials are in very early stages, testing safety and finding a dose that is effective in humans. Small numbers of people with a variety of cancers will be carefully monitored while the treatment is tested in clinical trials.

Don’t expect an FDA approved drug very soon, but the implications are positive. If one medication can treat up to half of all cancers it would have a major effect on costs, treatments, and results. Stay tuned.

Post Text Here
To put a smile on your face see Larry's latest cartoon.
To learn more about clinical trials, take a look at our book.

(c) 2012 Tom Beer and Larry Axmaker