Oxaliplatin, Gemcitabine, Erlotinib, and Radiation Therapy in Treating Patients With Unresectable and/or Metastatic Pancreatic Cancer or Biliary Tract Cancer

• Status: Completed
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving oxaliplatin together with gemcitabine, erlotinib, and radiation therapy may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of oxaliplatin, gemcitabine, and erlotinib when given together with radiation therapy in treating patients with unresectable and/or metastatic pancreatic cancer or biliary tract cancer.

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

Details

• Lead Sponsor: UNC Lineberger Comprehensive Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Erlotinib Hydrochloride; Gemcitabine; Oxaliplatin

Criteria

DISEASE CHARACTERISTICS:

• Biopsy confirmed diagnosis of any of the following:

• Pancreatic carcinoma

• Ampullary carcinoma

• Biliary tract (gallbladder or bile duct) carcinoma

• Unresectable and/or biopsy-proven metastatic disease

• Suitable for bimodality therapy, as determined by a medical oncologist and radiation oncologist

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2

• Life expectancy > 2 months

• ANC > 1,500/mm³

• Platelet count > 100,000/mm³

• Creatinine < 1.5 mg/dL

• Total bilirubin < 2 times upper limit of normal (ULN)

• AST < 3 times ULN (< 5 times ULN if liver metastases are present)

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No known hypersensitivity to platinum agent or gemcitabine hydrochloride

• No serious medical or psychiatric illnesses that would preclude giving informed consent

PRIOR CONCURRENT THERAPY:

• No prior radiotherapy to the upper abdomen

• More than 3 weeks since prior chemotherapy

• No prior erlotinib hydrochloride

• At least 5 days since prior and no concurrent CYP3A4 inducer/inhibitor