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PANCREATIC CANCER CLINICAL TRIALS

Pancreatic cancer clinical trials are offered in many parts of the word. These studies seek to establish the validity of new and possibly improved treatment options.

Clinical trials are, ideally, a part of a system in which a series of scientifically-controlled experiments shepherd a plausible medical agent, combination of agents or procedure through a process whereby the efficacy of the medical agent or procedure is established or not. In the U.S. this process is overseen by the Food and Drug Administration (“FDA”).

Until more recently, when fast-tracking has become more possible, the process of taking a potential agent from the biochemical stage through clinical trials to final FDA approval could take as long as 15 years. This process begins long before human testing. Generally, moving the process into human testing is predicated on successful animal results. It is then that the three primary phases of human testing begins. A phase I clinical trial with human subjects seeks to answer questions about whether a drug-agent is reasonably safe for use by humans. It also may seek to learn something of the biokinetics of the drug. And finally tries to establish what the maximum tolerated dose of the drug is. These are the only real aims of a phase I clinical trial, although researchers will, of course, be looking for subtle indications that the drug may show future promise.

Some fraction of phase I clinical trials will move on to the phase II, which seeks to answer the question as to whether the drug has, in fact, an apparent effect against the cancer in question (in our case pancreatic cancer). Many potential drug therapies go no further than phase II – as they show no real effect against pancreatic cancer. Successful phase II candidates move on to phase III clinical trials which seek to determine how the new therapy compares to existing standard therapies. Phase III clinical trials are the core measure of a potential new drug. Phase III clinical trials are controlled experiments whereby patients with similar characteristics are assigned to receive either the existing therapy or to receive the new therapy. After a time, the results of the arms of test are then compared. If the new agent shows similar or improved results as compared to existing therapy, (after another step or two) it is often approved for release by the FDA. There is even a phase IV to this process which has to do with after-approval monitoring of the new drug for side-effects, etc. as it makes its way into wider use.

The decision to participate in a clinical trial for pancreatic cancer is a big one and should not be taken lightly. At its very heart a clinical trial is an experiment. Consequently, clinical trials contain inherent risk-both active risks and passive risks. An example of an active risk might be encountering an unexpected side-effect of the drug. An example of a passive risk might include the clinical trial protocol which may call for being off all standard medical treatment for 28 days (which is not uncommon) before beginning the clinical trial. For many diseases, this may not matter much. But with pancreatic cancer, this kind of a rule may matter a great deal.

On the other hand, the prognosis of certain stages of pancreatic cancer may not be great. Some of the emerging treatments may appear to hold more promise than existing ones. Approaching the possibility of participating in a clinical trial in a carefully reasoned, intelligent manner, depending on circumstance, may be a smart personal decision.

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There are many issues to consider. Am I a good candidate for a clinical trial? What emerging drug or combination of drugs looks to be promising? Is the clinical trial really (realistically) more promising than existing therapy? Which phase of clinical trial am I comfortable participating in? Which institution is hosting the clinical trial? What is their reputation? What is their location relative to mine? Which physicians will be involved? What support do I have?

And there are other issues – many of them. Probably more than you can come up with on your own. This is when a strong bond with your personal physician can be of great service to you. Be sure to ask for aid and guidance from your physician (and other health professionals) in helping sort through these kinds of complicated decisions regarding pancreatic cancer clinical trials.

Reliable sites to find pancreatic cancer clinical trials:

ABSTRACTS:

The following are descriptions of titles of abstracts of medical journal articles that may be interesting or useful to those who are interested in further information about this topic.These abstracts can be searched Here.

  • 12-Oct-16 – Microbubbles may potentiate Gemzar in cancer of the pancreas 
  • 1-Oct-16 – Radiotherapy post-FOLFIRINOX regimen 
  • 6-Sep-16 – Percutaneous electroporation in locally advanced Cancer of the pancreas 
  • 17-Aug-16 – FOLFIRINOX (modified) then Xeloda and radiation for borderline surgical adenocarcinoma of the pancreas 
  • 1-Jan-14 – Early Study of a Kinesin Motor Protein in Combination with Gemcitabine for Adenocarcinoma of the Pancreas
  • 19-Oct-13 – Monoclonal EGFR Antagonist in Combination with Gemzar for Cancer of the Pancreas
  • 20-Aug-13 – Nano-Irinotecan as Second line for Cancer of the Pancreas
  • 1-Aug-13 – Chemoradiation with FDR Gemcitabine and Avastin
  • 1-Aug-13 – Phase Two with Gemcitabine and Mitomycin C in Administered Different Modalities
  • 1-Feb-13 – Phase 2 Clinical Trial of Gemzar Plus a Kallikrein Inhibitor for Pancreatic Cancer
  • 1-Sep-12 – Phase II Clinical Trial of Ixempra Plus Erbitux for Cancer of the Pancreas
  • 1-Aug-12 – Phase 1 Clinical Trial with Chemotherapy Plus a High Blood Pressure Drug
  • 1-May-12 – Gemzar and LEP-ETU vs. Gemzar – a Phase 2 Clincal Trial for Pancreatic Cancer
  • 1-Nov-11 – 5-FU and Gemzar for Pancreatic Cancer
  • 1-Jan-11 – Are Phase I Trials a Reasonable Treatment for Cancer of the Pancreas?
  • 1-Aug-10 – Maximum Tolerated Dosage of Gemzar in Phase I Chemoradiation Clinical Trial
  • 1-Dec-09 – Ellence and Gemzar in Phase 1 Clinical Trial for Stage 4 Cancer
  • 1-Sep-09 – Chemoradiation with Avastin Plus Xeloda in a Phase 2 Clinical Trial for Pancreatic Cancer
  • 15-Oct-08 – Platinum Drug and Xeloda Phase II Study for Stage 4 Pancreatic Cancer

Our science board is composed of:

James Abbruzzese, MD Chief, Medical Oncology Duke University

Markus Büchler, MD Chairman, Surgery Heidelberg University, Germany

Ralph Hruban, MD Director, GI / Liver Pathology Johns Hopkins University

Eileen O’Reilly, MD Associate Director for Clinical Research – Memorial Sloan-Kettering Cancer Center

Margaret Tempero, MD Chief, Medical Oncology University of California at San Francisco

Our Philosophy About Pancreatic Cancer

Pancreatic cancer is a serious disease. Taking an aggressive rational stance at the earliest possible time, supported by the best medical team, and treated in the most appropriate manner gives the best chance for survival.

We believe in strong patient-physician bonds, scientifically-based treatment, and that comfort can come from knowing that everything that reasonably can be done – is being done.

That the best approach is meeting cancer of the pancreas head-on and armed with the best available information.

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Genetic Testing for Pancreatic Cancer

PROPOSED: Every newly diagnosed person with pancreatic cancer (ductal adenocarcinoma of the pancreas) should receive genetic screening prior to beginning treatment – to test for germline genetic mutations in the homologous recombination DNA repair pathway, including genes such as BRCA1, BRCA2, PALB2, and others. These results, in from 12% to 17% of pancreatic cancer patients, suggest that treatment that includes DNA cross-linking agents such as platinum compounds or PARP inhibitors may be superior to standard best practices therapy.


OFFER: Color Genomics offers a 30-gene cancer panel for $224 (normally $249) when the Promotion Code “PANCREATIC” is entered at checkout (price will reduce upon entering this code). This is a physician-ordered saliva kit. Click Here for more information

RATIONALE: The age of precision medicine in pancreatic cancer is approaching … [MORE]

Our mission is to promote awareness, increase education, and further pancreatic cancer research, specifically research aimed at early diagnosis.

Pancreatic cancer is the 3rd leading cause of cancer-related death in the U.S. It is expected to become the 2nd leading cause of cancer-related death by the year 2020. Studies show that death rates for pancreatic cancer are increasing while for most other cancers they are declining.
It’s time to change these statistics!

Early diagnosis is key:
Survival increases dramatically if patients are diagnosed in time for surgery!

For medical information Click Here for our sister site Pancreatica.org

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Pancreatic Cancer Blog

One of the observations that physicians often made when the standard of care treatment typically consisted of the chemotherapy drug agent of gemcitabine alone, was that many patients with pancreatic cancer (ductal adenocarcinoma of the pancreas) seemed to feel better after the initiation of treatment… More Here

 

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