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Research Initiatives for Novel Future Therapies

Pancreatic cancer shows incredible resistance to standard treatment regimens. Therefore, the hope of The Pancreas Center medical oncology team is to develop innovative therapies that will overcome this resistance. We are currently exploring three strategies:

• Induce Alternate Cell Death Pathways (Aponecrosis vs. Apoptosis)
• Development of Chemotherapy Regimens to Overcome Mutant p53 Drug Resistance (GTX and new GTX - Sorafenib regimens).
• Exploit Specific Genetic Mutations to your Advantage (BRCA)

GTX (Gemzar, Taxotere, Xeloda)
The GTX chemotherapy regimen for pancreatic cancer was developed in the laboratory of Dr. Fine at Columbia University's College of Physicians and Surgeons over a two-year period. This drug combination has low toxicity to patients and decreases mutant p53 resistance to chemotherapy in tumors such as pancreatic cancer which has an incidence of mutant p53 in 80% of patients.

GTX has the highest response rate in the U.S. and Europe in Phase II trials. Phase III trials are planned.

p53 Peptide Therapy is a synthetic peptide designed to attack the pathogenic mutation responsible for 85% of pancreatic cancers and over 50% of all human cancers including breast, lung, colon, and prostate cancer. Synthetic p53 peptides work by forcing a shape change in mutant p53 so that it becomes functional. This has been developed and patented at Columbia; we expect testing of the peptide to begin within two years.

Ras and p53 Gene Therapy is a gene therapy that destroys only those cells that exhibit both mutant ras and mutant p53 thereby diminishing the threat of cancer, but protecting the body from unnecessary harm. Approximately 95% and 80% of pancreatic cancer patients have mutant ras and mutant p53 respectively. This gene therapy was developed and patented at Columbia; we expect trials to begin within the next two years.

AAA can kill pancreatic cancer cells by alternative cell death pathways (aponecrosis). The AAA combination is unique because there are no classic "chemotherapy drugs," and thus it is less toxic to the patient. Clinical trials with the Pancreas Center are pending so that this new treatment regimen can be tested.

Clinical Trials Open Now

Phase II study for inoperable nonmetastatic pancreatic cancer (stage IVa) with neoadjuvant GTX and radiation therapy with Gemzar
Open to patients with inoperable, non-metastic pancreatic concer to convert them to an operable status.

GTX-Sorafenib Phase II Chemotherapy for metastatic pancreatuc cancer patients
We have found in our laboratory that the anti-tumor effect can be increased two-fold by adding the new drug Sorafenib (Noxavar) to GTX. This trial will open by September 2008 for patients and we believe the results will be superior to the exciting results already obtained with the GTX prospective trial which closed in 2008.

Phase II Study of Capecitabine-Temozolomide (CAPTEM) chemotherapy for metastatic neuroendocrine cancer
This study is open to enrollment for adrenal neuroendocrine cancers based upon our laboratory research findings at Columbia.

Phase II randomized study to assess the efficacy and safety of AZD6244 vs. capecitabine (Xeloda) in patients with advanced or metastatic pancreatic cancer, who have failed first line gemcitabine therapy (Gemzar)
Open to patients with advanced or metastatic cancer for whom gemcitabine (Gemzar)

Phase II GTX with sirolimus in metastatic pancreatic cancer
Open to all patients with metastatic pancreatic cancer

Phase II study with GTX for adjuvant therapy in pancreatic cancer
Open to all patients who have undergone resection or attempted resection for pancreatic cancer and will need post-operative chemotherapy to prevent recurrence of their cancer.

For more information or to enroll a patient in one of these studies, please contact The Pancreas Center Clinical Trials Coordinator: Victoria Seranno 212.305.3856