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University of Florida Shands Cancer Center


Faculty

Carmen Allegra, MD
Kevin Behrns, MD
Ronald Cabrera, MD
James Caridi, MD
Shailendra S. Chauhan, MD
Long Dang, MD, PhD
Kfir Ben-David, MD
Roberto Firpi, MD
Christopher Forsmark, MD
Thomas George, MD, FACP
Steven Hochwald, MD
Emina Huang, MD
Steven Hughes, MD
Judith Lightsey, MD
Joseph Magliocca, MD
William Mendenhall, MD
David Nelson, MD
R. Charles Nichols, MD
Sanda Tan, MD, PhD
Mihir S. Wagh, MD
Ivan Zendejas, MD
Robert Zlotecki, MD, PhD


Useful Links

UF Department of Medicine Division of Hematology and Oncology
Shands at UF
UF Shands Cancer Center
UF&Shands Clinical Trials



GI Oncology Program Update: Vol. 1, Issue 1

This newsletter provides information regarding new therapies and treatment options for patients with gastrointestinal (GI) malignancies at the University of Florida Shands Cancer Center. All patients have the opportunity to participate in clinical trials and will receive a personalized multidisciplinary treatment plan through multispecialty clinic assessments on a single appointment day.

To refer a patient for one of these trials or consultation, please contact the UF&Shands GI Oncology Program Clinical Coordinator, Coleen Booker, at 352.265.0990.

If you would like additional information about any of these trials, please contact our GI Oncology Program Research Coordinator, Alison Ivey, at 352.265.0680 ext. 88411.



In This Issue:

Cholangiocarcinoma:
Phase II study of sorafenib (NSC-724772) and erlotinib (NSC-718781) in patients with advanced gallbladder carcinoma or cholangiocarcinoma
Colorectal Cancer:
Phase II study of treatment selection based upon tumor thymidylate synthase expression in previously untreated patients with metastatic colorectal cancer
Phase I/II study of KRN330 plus irinotecan after first -line or adjuvant FOLFOX/CapOx failure in patients with metastatic colorectal cancer
Statin polyp prevention trial in patients with resected colon cancer
Esophagogastric Cancer:
Phase III trial evaluating the addition of cetuximab to paclitaxel, cisplatin and radiation for patients with esophageal cancer who are treated without surgery
Liver Cancer:
Randomized pilot study of the effect of sorafenib dosing schedule on tolerability and drug delivery
Pancreas Cancer:
Phase III study of chemotherapy and chemoradiotherapy with or without HyperAcute®-Pancreas (algenpantucel-L) immunotherapy in subjects with surgically resected pancreatic cancer
Study using photon/proton beam radiation therapy and chemotherapy for unresectable carcinoma of the pancreas




Phase II Study of Sorafenib (NSC-724772) and Erlotinib (NSC-718781) in Patients with Advanced Gallbladder Carcinoma or Cholangiocarcinoma

Gallbladder and other biliary tract cancers are increasing in incidence with only modest clinical gains made in systemic therapy. Both erlotinib and sorafenib have some clinical activity as single agents in patients with advanced biliary cancers with very manageable side effects. In an attempt to maximize the potential benefit of such targeted treatments in advanced biliary cancers, one approach is to target different intracellular pathways simultaneously. The cross-talk between the EGFR and VEGF pathways lends theoretical support to combining two agents that target these pathways. Both of these pathways are overexpressed or upregulated in these cancers. This clinical trial tests this novel combination in treatment naïve patients with metastatic or unresectable gallbladder carcinoma or cholangiocarcinoma. This trial is being conducted in collaboration with the Southwest Oncology Group (SWOG) and the National Cancer Institute (NCI).

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Phase II study of treatment selection based upon tumor thymidylate synthase expression in previously untreated patients with metastatic colorectal cancer

Selection of initial therapy for patients with metastatic colorectal cancer has become complicated by the availability of several regimens with significant activity. Truly personalized therapy requires the identification of which patients are least or most likely to respond to a particular treatment. One example of this is the observation that tumor over-expression of thymidylate synthase (TS) is associated with 5-FU resistance. However, 5-FU based therapies are otherwise standard treatments for metastatic colorectal cancer. Given the existence of an active non-5FU treatment option (i.e. IROX), it is hypothesized that a subset of patients with metastatic colorectal cancer would fare better with IROX than a standard 5-FU-based regimen (e.g. FOLFOX). This study assigns treatment based on intratumoral TS levels in patients with newly diagnosed metastatic colorectal cancer. To be eligible, patients must either have access to a previously obtained biopsy of a metastatic site (paraffin-embedded) or be willing to undergo a biopsy of a metastatic site. This trial is being conducted in collaboration with the Eastern Cooperative Oncology Group (ECOG) and the National Cancer Institute (NCI).

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Phase I/II study of KRN330 plus irinotecan after first -line or adjuvant FOLFOX/CapOx failure in patients with metastatic colorectal cancer

In the last decade, remarkable progress has been made in the management of metastatic colorectal cancer. Standard cytotoxic chemotherapy (e.g. 5-FU, oxaliplatin, irinotecan) and targeted monoclonal antibody-based therapies, such as bevacizumab (vascular endothelial growth factor inhibitor) and cetuximab and panitumumab (EGFR inhibitors), have significantly extended patient survival. However, new therapies are still desperately needed in this common disease. This study is looking at KRN330, a novel monoclonal antibody targeting a cell-surface receptor common to colorectal cancers, in combination with Irinotecan in patients with metastatic colorectal cancer whose disease has progressed despite an oxaliplatin based regimen. This trial is being conducted in collaboration with Kyowa Hakko Kirin Pharma, Inc.

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Statin Polyp Prevention Trial in Patients with Resected Colon Cancer

The best offense is a good defense as most colorectal cancers are preventable. This phase III randomized, placebo-controlled, double-blind study evaluates the effectiveness of the HMG-CoA reductase inhibitor rosuvastatin in preventing the occurrence of adenomatous polyps of the colon or rectum, metachronous colorectal carcinoma, and colon cancer recurrence among early stage colon cancer patients treated for cure. Chemotherapy at the treating physician's discretion is allowed, consistent with standards of care. This trial is being conducted in collaboration with the National Surgical Adjuvant Breast and Bowel Project (NSABP) and the National Cancer Institute (NCI).

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Phase III trial evaluating the addition of cetuximab to paclitaxel, cisplatin and radiation for patients with esophageal cancer who are treated without surgery

EGFR is expressed in between 50% and 80% of all esophageal cancers, and its expression is associated with poor prognosis. Accumulating clinical evidence suggests that EGFR represents a viable target in the treatment of esophageal cancer. Cetuximab is a known radiosensitizer and is effective in head and neck malignancies. This study is a phase III randomized controlled trial evaluating the addition of cetuximab to the standard combination of paclitaxel and cisplatin concurrent with radiotherapy for patients with esophageal cancer in whom surgery is not planned. This definitive curative intent therapy offers the opportunity to improve survival in a group of patients without the use of surgical intervention. This trial is being conducted in collaboration with the Radiation Therapy Oncology Group (RTOG) and the National Cancer Institute (NCI).

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Randomized pilot study of the effect of sorafenib dosing schedule on tolerability and drug delivery

The outcomes for patients with hepatocellular carcinoma (HCC) have recently been improved with the availability of sorafenib. However, the tolerability and duration of sorafenib use for HCC is significantly limited in clinical practice due to underlying liver dysfunction and therapy-associated adverse events (AEs) which result in frequent dose reductions and discontinuations. Treatment-related adverse events occurred in 80% of the sorafenib group in the SHARP trial. This study attempts to modify the dosing of sorafenib to minimize the symptoms while attempting to maximize the neoplastic benefit and patient ability to remain on treatment.

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Phase III study of chemotherapy and chemoradiotherapy with or without HyperAcute®-Pancreas (algenpantucel-L) immunotherapy in subjects with surgically resected pancreatic cancer

Surgical resection of pancreatic cancer offers the only chance for cure in this dreaded disease. However, even with maximal attempts to remove the cancer, along with post-operative chemotherapy with or without radiotherapy, long term outcomes remain poor. Novel therapies are desperately needed, but recent attempts to use monoclonal antibody or tyrosine kinase-based therapies to inhibit signal transduction have been disappointing. This study utilizes immune modulation through vaccination with a novel pancreatic antigen. Enrollment offers patients access to HyperAcute®-Pancreas (algenpantucel-L) immunotherapy in addition to standard adjuvant therapy after surgical resection of pancreatic cancer.

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Study using proton beam radiation therapy and chemotherapy for unresectable carcinoma of the pancreas

Locally advanced pancreatic cancer is incurable, but controllable through the use of effective chemotherapy and radiotherapy. Pain, biliary patency, and survival have been proved to be improved by this combination. This study incorporates proton beam radiotherapy into the treatment of advanced pancreatic cancer in an attempt to improve these local control parameters and ultimately benefit the patient's quality and quantity of life.

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UF Shands Cancer Center
Gastrointestinal Oncology Program
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