Cetuximab, Gemcitabine, and Oxaliplatin Followed By Surgery or External-Beam Radiation Therapy and Capecitabine in Treating Patients With Locally Advanced, Nonmetastatic Pancreatic Cancer That Cannot Be Removed By Surgery

• Status: Completed
• Trial end date: 2013-04-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as gemcitabine, oxaliplatin, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sometimes when chemotherapy is given, it does not stop the growth of tumor cells. The tumor is said to be resistant to chemotherapy. Giving cetuximab together with chemotherapy may reduce drug resistance and allow the tumor cells to be killed. Giving cetuximab and chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Radiation therapy uses high-energy x-rays to kill tumor cells.

PURPOSE: This phase II trial is studying how well giving cetuximab together with oxaliplatin and gemcitabine followed by surgery or external-beam radiation therapy and capecitabine works in treating patients with locally advanced, nonmetastatic pancreatic cancer that cannot be removed by surgery.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of South Carolina
• Treatments: Capecitabine; Cetuximab; Gemcitabine; Oxaliplatin

Criteria

DISEASE CHARACTERISTICS:

• Histologically or radiologically confirmed pancreatic cancer, meeting both of the following criteria:

• Locally advanced, nonmetastatic disease

• Surgically unresectable disease

• Measurable disease, defined as unidimensionally measurable by physical exam or imaging study

• The following are considered nonmeasurable disease:

• Bone-only disease

• Pleural or peritoneal effusions

• CNS lesions

• Irradiated lesions in the absence of progression after radiotherapy

• No history or evidence of CNS disease

• No metastatic disease to distant organs (e.g., liver, lung, brain, or bone)

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2

• Granulocyte count ≥ 1,500/mm³

• Platelet count ≥ 100,000/mm³

• Bilirubin ≤ 2.0 mg/dL

• Creatinine ≤ 2.0 mg/dL

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for ≥ 90 days after completion of study therapy

• No acute hepatitis

• No known HIV positivity

• No active or uncontrolled infection

• No significant history of uncontrolled cardiac disease, including, but not limited to, any of the following:

• Uncontrolled hypertension

• Unstable angina

• Myocardial infarction within the past 6 months

• Uncontrolled congestive heart failure

• Cardiomyopathy with decreased ejection fraction

• No prior severe infusion reaction to a monoclonal antibody

• No active second malignancy other than nonmelanoma skin cancer

• No history of deep vein thrombosis

• No history of bleeding diathesis or coagulopathy

• No other severe concurrent disease, mental incapacitation, or psychiatric illness that would preclude study participation

PRIOR CONCURRENT THERAPY:

• No prior therapy for pancreatic cancer

• No prior therapy specifically targeting the epidermal growth factor-receptor pathway

• No major surgical procedure or open biopsy within the past 28 days

• No prior radiotherapy or chemotherapy

• No prior or concurrent full-dose anticoagulants or thrombolytics