Protocol Title:

A Multi-Institutional Phase II Study of Neoadjuvant Gemcitabine and Oxaliplatin with Radiation Therapy in Patients with Pancreatic Cancer

Protocol Status:

Open

Protocol Number:

J0686

Type of Cancer:

Pancreatic

Principal Investigator:

Joseph Herman, M.D.

Research Nurse:

Beth Griffith, R.N.

Phase Number:

II

General Eligibility:

Patients with pancreatic cancer-patients must have a resectable cancer-good physical condition, adequate blood levels and organ function-no other malignancies, diseases, or other uncontrolled disorders or conditions that may interfere with the safe delivery of the protocol treatment. No prior abdominal radiation or chemotherapy for pancreatic cancer

Purpose:

To determine the 2 year disease free survival in patients with resectable pancreatic cancer treated preoperatively with a combination of full dose gemcitabine,oxaliplatin, and concurrent radiation therapy.To determine the toxicity profile of this regimen.To look at the objective response rate, surgical resectability rate, time to treatment failure, patterns of failure and the overall survival of the proposed treatment. To look at the pathologic effects fo neoadjuvant therapy. To evaluate the usefulness of PET imaging in determining response to therapy and predicting overall survival of the treatment

Treatment:

Protocol therapy will include up to four, 28 day cycles of chemotherapy. Radiation therapy will be given during cycle 1 of chemotherapy. Surgical treatment will occur after cycle 2 if patient is resectable. Surgical treatment, if it occurs, will not be protocol specified. If resection occurs, a 3rd and 4th cycle of chemotherapy is recommended if recovery is sufficient to provide same.