| Exclusion Criteria: | 1) Distant metastatic disease, second malignancy or peritoneal seeding;
2) Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (For example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible);
3) Prior systemic chemotherapy for pancreatic cancer; Note: previous chemotherapy for malignancies other than pancreatic cancer is allowed, provided that chemotherapy was completed > 3 years prior to study entry.
4) Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields;
5) Any major surgery within 28 days prior to study entry (for example, insertion of a vascular access device, insertion of a biliary stent, exploratory laparotomy, and laparoscopy are not considered major surgery);
6) Severe, active co-morbidity, defined as follows: Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months; Transmural myocardial infarction within 6 months prior to study entry; Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration; Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days before registration Uncontrolled malabsorption syndrome significantly affecting gastrointestinal function; Any unresolved bowel or bile duct obstruction; Major resection of the stomach or small bowel that could affect the absorption of capecitabine;
7) Continued from 6: Acquired immune deficiency syndrome (AIDS) based upon current Center for Disease Control (CDC) definition; *note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because patients receiving antiretroviral therapy may experience possible pharmacokinetic interactions with capecitabine.
8) Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception during the course of the study and for women, for 3 months after the last study drug administration and for men, for 6 months after the last study drug administration; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.
9) Women who are lactating at the time of registration and who plan to be lactating through 3 months after the last study drug administration.
10) Prior allergic reaction to capecitabine or gemcitabine
11) Prior treatment with IGF-1R inhibitor;
12) Participation in another clinical treatment trial while on study.
13) Existing VTE requiring anti-coagulation therapy.
14) Hearing impairment (Grade 2 or worse) |