Clinical trials are not for everybody and are not always successful. It is, after all, a trial. But for me, entering a clinical trial when I had an aggressive recurrence of ovarian cancer, it was the right choice. Admittedly, I entered the trial with little expectation of success, but I was so wrong.
My trial drug was a monoclonal antibody drug that works by turning on the “suicide” switch, a process called apoptosis. Healthy cells know when to die, but cancer cells go awry and keep growing uncontrollably, building tumors that eventually kill the host. I was "hosting" seven new tumors (four on the liver) and standard treatments were no longer working.
I was nervous about testing a unproven drug, especially at Phase I - the first time it was tried on humans. What new thing might grow as a result? Could I end up worse than with my current problem? However, consulting with several oncologists about my options and by gaining an understanding of how monoclonal antibodies function, I entered the trial.
In all the years I’ve dealt with cancer treatments, this was the easiest experience. I was not ill during treatment, experienced virtually no side effects. I was examined more closely than I ever have been; essentially every orifice and bodily function was monitored with great interest by the researchers. Most importantly, several tumors disappeared after a few weeks, while the remainder became necrotic with no signs of life for two years.
Did it cure my cancer? No. But it bought me more time; time without painful treatments, a holiday of sorts from a long, difficult cancer journey.
Not every trial is this successful. In fact, other patients on the same drug did not have the same response, but I know that clinical trials are another weapon in the arsenal that helps me stay alive.
For more information, go to the National Institutes of Health website: www.clinicaltrials.gov.
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Annette,
Thank you for an excellent and accurate response. The only time a placebo or no treatment is allowed in an oncology trial is when no standard treatment exists. Even in these studies, the patient receives what is called "best supportive care," drugs for comfort and to control disease symptoms. The National Cancer Institute website has a great website that discusses this and other issues that patients considering a clinical trial should consider. http://www.cancer.gov/clinicaltrials/learning/should-I-take-part
In the PRECEDENT Study, participants are treated either with Doxil, an FDA approved drug used to treat ovarian cancer, or with a combination of Doxil and EC145, the investigational drug.
Dave Morgenstern
July 16, 2009 - 8:41amDirector, Clinical Affairs
Endocyte, Inc.
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how do you know you won't be one of control group? you'd better believe wholeheartedly in the placebo effect. i wish i could be so credulous. persuade me please.
July 6, 2009 - 5:31amThis Comment
According to the National Institutes of Health, in oncology trials, there is no placebo. Patients are given treatment with standard or trial drugs, but never "untreated." Also, if the disease progresses while they are on the trial drug, they are taken out of the trial and returned to traditional treatment. Standards for oncology trials are extremely rigid. You can find more info about the clinical trial process at this site: http://www.ovariancancer.org/index.cfm?fuseaction=Page.viewPage&pageId=526
July 11, 2009 - 8:15amI hope this helps. If you want more info on my experience, please contact me again. Annette
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That website is www.endocyte.com/precedent
June 26, 2009 - 9:04amThis Comment
Annette,
Thank you for a great article sharing your experience. Women interested in information about Endocyte's ongoing clinical trial for women with platinum-resistant ovarian cancer can go to the PRECEDENT page at Endocyte's website www.precedent.com.
Dave Morgenstern
June 26, 2009 - 9:02amDirector, Clinical Affairs
Endocyte, Inc.
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This is a great article, Annette! Thanks for sharing your story. I wanted to let you and your readers know about our clinical trials matching service: www.healogica.com. We just launched the website 2 months ago. Check it out!
Ed Shin
June 19, 2009 - 7:27am[email protected]
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