Radiation Therapy and Capecitabine/Oxaliplatin Chemotherapy in the Treatment of Locally Advanced Pancreas Adenocarcinoma

• Status: Completed
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The study is a prospective phase I trial of radiation therapy concurrent with capecitabine and oxaliplatin chemotherapy in the treatment of locally advanced pancreas adenocarcinoma. Eligibility criteria include pathologically confirmed, non-metastatic adenocarcinoma of the pancreas that is surgically unresectable. Patients will undergo radiation therapy (28 treatments of 1.8 Gy for a total of 50.4 Gy) concurrent with capecitabine and oxaliplatin chemotherapy. The primary objective of the study is to determine the maximum tolerated doses of capecitabine and oxaliplatin when delivered concurrently with 50.4 Gy radiation therapy with or without surgery in this patient population.

Secondary objectives of the study are to determine the tumor response rate, survival rate, local control rate and the rate of distant metastases following capecitabine, oxaliplatin, and radiation therapy with or without surgery and to determine the rate at which patients with unresectable disease become resectable.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Utah
• Treatments: Capecitabine; Oxaliplatin; Pancrelipase

Criteria

Patient Selection Criteria

• Pathologically confirmed adenocarcinoma of the pancreas.

• No distant metastases (no metastases beyond regional lymph nodes).

• Deemed surgically unresectable by a surgical oncologist due to hepatic artery, celiac axis, superior mesenteric artery, superior mesenteric vein, portal vein, aorta, inferior vena cava, and/or rib/vertebral body involvement as defined by CT/MRI scan and/or endoscopic ultrasound (EUS).

• No malignancy (within the past two years) except for non-melanomatous skin cancer or carcinoma in situ of the cervix, uterus, or bladder.

• No previous chemotherapy for pancreatic cancer.

• No prior irradiation to the planned field.

• Zubrod performance status 0-1.

• Granulocytes > 1,800, platelets > 100,000/ul, bilirubin < 2.0 mg/dL, ALT < 3x upper limits of normal, creatinine < 3.0 mg/dL.

• No significant infection or other coexistent medical condition.

• No pregnant or lactating women.

• Age > 18 years old.

• Signed study-specific consent form prior to registration.