Stage IV b Clinical Trial at the UPMC

This is not medical advice. I am sharing information about a clinical trial which may be of interest to caregivers or EC patients. Any opinion is my own. I am not a medical professional and this is not an endorsement of any specific drug or procedure. This is not a recommendation. Use this information as you will.
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All,

Below is information about a clinical trial at the UPMC being run by Dr. Gibson for Stage Ivb EC patients with mets and/or recurrent EC who have only used one chemo agent since the recurrence or mets. It is a promising treatment.

Ironically, this is the treatment that Dr. Ajani at MD Anderson prescribed for my father, but which was turned down by Medicare and Insurance because it was off label and not FDA approved. Of course, my dad could get the treatment if we could pay out of pocket 10,000 to 20,000 dollars a month. We are looking into whether or not he can qualify to participate in the trial at UPMC, but I wanted to share this with others on the Board looking for alternatives.

There are spots available but the trial is only being run at the UPMC. Barb is also looking into this with Vince.

If you have any questions please let me know.

The clinical trial information can be found at clinical trial at the UPMC:
http://www.upmccancercenters.com/trials/trialDisplay.cfm?id=4979&type=D. (paste into your browser)

Clinicaltrials.gov. - NCT00836277:
http://clinicaltrials.gov/ct2/show/NCT00836277?term=Irinotecan+++Panitumumab+as+Second-Line+Therapy+for+Patients+with+Advanced+Esophageal+Adenocarcinoma&rank=1


Below is an excerpt for the Protocol Summary found on the UPMC website above:

Protocol Title:
Phase II Study of Irinotecan vs. Irinotecan + Panitumumab as Second-Line Therapy for Patients with Advanced Esophageal Adenocarcinoma

Principal Investigator: Michael Gibson

Study Design and Primary Aim:

Esophageal cancer is a highly lethal malignancy that is increasing in incidence, especially the histologic subtype of adenocarcinoma. Fully 50% of patients present with advanced, incurable disease. Of the remainder who are diagnosed at curable stages, at most 30% are long-term survivors. Advances in therapy for both local and advanced disease have been stagnant in the past few decades. As such, there is an urgent need for advances in therapy. The development of modern cytotoxic chemotherapy and in particular, biologically targeted agents, provides hope for improving the outcome in these patients.

The semi-synthetic derivative of camptothecan, irinotecan, is active in esophageal adenocarcinoma, both alone and in combination with cisplatin. Use as front-line therapy in both multi-modality regimens and combination chemotherapy is common. More recently, the elucidation of the role of the epidermal growth factor receptor (EGFR) pathway in esophageal cancer has resulted in the pre-clinical and clinical study of the activity of EGFR directed agents for treatment of esophageal cancer.

The anti-EGFR antibodies, panitumumab and cetuximab, are active as both single agents and in combination with cytotoxic chemotherapy in patients with colorectal adenocarcinoma. In particular, the combination of irinotecan and cetuximab is active for irinotecan refractory colorectal cancer, while panitumumab is active compared with best supportive care. In our clinic, we have empiric evidence for the unexpectedly significant activity of the combination of cetuximab and irinotecan as third-line treatment for advanced esophageal adenocarcinoma. Panitumumab has the clinical advantages, compared with cetuximab, of being fully human,, thus resulting in a lower frequency of infusion reactions.

This recent experience with these targeted agents in solid tumors, while still promising, has yielded relatively modest results.7-11 Notably, however, retrospective analyses of clinical trials are consistently revealing that differences in treatment effect between subgroups of patients can be associated with specific molecular profiles.12-18 These findings suggest the potential for a more rational approach to trial design that would use patient and tumor characteristics to select patients for therapy, thus enriching the population of responders.

Best,
Cindy