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Alternate Title Phase III Randomized Study of Gemcitabine Hydrochloride With or Without Capecitabine and/or Radiotherapy Versus Gemcitabine Hydrochloride With or Without Erlotinib Hydrochloride in Patients With Unresectable Locally Advanced Adenocarcinoma of the Pancreas
Trial Description Drugs used in chemotherapy, such as gemcitabine and capecitabine, 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. It is not yet known which regimen of chemotherapy with or without erlotinib and/or radiation therapy is most effective in treating pancreatic cancer. This randomized phase III trial is studying giving gemcitabine together with or without capecitabine and/or radiation therapy to see how well it works compared with giving gemcitabine together with or without erlotinib in treating patients with locally advanced pancreatic cancer that cannot be removed by surgery. Eligibility criteria include the following:
Final eligibility for a clinical trial is determined by the health professionals conducting the trial. Patients will be randomly assigned (have an equal chance of being placed) to one of two treatment groups. Patients in group one will receive an infusion of gemcitabine every 1-2 weeks for 4 months. Patients in group two will receive an infusion of gemcitabine every 1-2 weeks and erlotinib by mouth once a day for 4 months. Some patients will then be randomly assigned a second time to one of four treatment groups. Patients in group one will continue to receive gemcitabine every 1-2 weeks for 2 months. Patients in group two will continue to receive gemcitabine every 1-2 weeks and erlotinib by mouth once a day for 2 months. They will then receive erlotinib alone once a day for as long as benefit is shown. Patients in group three will receive capecitabine by mouth twice a day and undergo radiation therapy 5 days a week for 6 weeks. Patients in group four will receive capecitabine by mouth twice a day and undergo radiation therapy 5 days a week for 6 weeks. Beginning 15 days later, they will receive erlotinib alone by mouth once a day for as long as benefit is shown. Tumor tissue samples will be studied in the laboratory. After finishing treatment, patients will be evaluated every 2 months. Important: For more details about this trial, refer to the Health Professional version of the trial summary. If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site. Trial Lead Organizations GERCOR Groupe Cooperateur Multidisciplinaire en Oncologie
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