Surgical Oncology GI Update

2008 Completed Protocols

UAB 0560 "Evaluating the Role of Anti-Epidermal Growth Factor Receptor Antibody, 225, as a radiosenstitizer with chemoradiation for locally advanced pancreatic cancer" a Phase I trial which was part of a SPORE grant was completed in August 2008. The trial began November 5, 2005 and enrolled 16 patients. Data is compiled and the results are promising. A paper is due out soon to expound of the results and findings.

2008 Active Protocols

UAB Protocol #0601 "A Phase II Double-Blind Placebo Controlled,Multi-centered adjuvant trial of the efficacy,immunogenicity, and safety of GI-4000; an inactive recombinant saccharomyces cerevisiae expressing mutant K-Ras protein combined with a gemcitabine regimen versus a gemcitabine regimen with placebo,in patients with post resection R0/R1 pancreatic cancer with tumor sequence confirmation of K-Ras Mutations" Still enrolling with an increase in enrollment time.

UAB PROTOCOL# Gastrointestinal Stromal Tumors

• going well and producing interesting results. Additionally, a different GIST cell line has been acquired from Japan.

UAB PROTOCOL # Fibroblast-Epithelial Interaction in Pancreatic Cancer

• going well and producing interesting results to include

UAB 0808- A Phase II Study of Short-Course Preoperative Erlotinib Followed by Post-Operative Erlotinib-Gemcitabine in Patients with Resectable Pancreatic Adenocarcinoma

Pending Protocols

UAB XXXX, "A Phase II trial of Neoadjuvant Sunitinib in patients with Bulky GIST," a trial in collaboration with Dr. James Posey and Pfizer, Inc. Should begin enrollment early 2009. Tamoxifen and Gemcitabine in Unresectable Cholangiocarcinoma, Phase I study currently unsubmitted, awaiting SSO funding.

2008 Grant Applications Submitted

List grant application titles, place of application, for example:

• Lustgarten Foundation for Pancreatic Cancer Research: "title of grant," (Not Funded)
• State of Alabama, Department of Public Health (ADPH) General Fund Budget Grant for Coordinated Drug Trial (Not Funded)
• "Personalized Pancreatic Cancer Therapy: Erlotinib response predictive assays in EUS-FNA biopsies." NIH 2009 Application (Not Funded)

2009 Grant Applications Submission Pending

• Collaborative NIH grant with the University of Kentucky "Building a predictive biomarker of response to EGFR inhibitors for solid tumors"
• Collaborative NIH study (Pending) with Dr.Kvale in Palliative Care. Name Unknown at present
• Collaborative DOD grant with the University of Kentucky "Building a predictive biomarker of response to EGFR inhibitors for solid tumors" Pending will be submitted on April 17th 2009. This is similar to the NIH except that this will be for 36 months versus 24 for the NIH grant.
• In the process of submitting "Combination therapy in Gastro-Intestinal Malignancies" in collaboration with Igor Dmitrive Ph.D. IRB approval pending. Starting talks with "Life Raft Group" to work in collaboration with their ongoing GIST research.