Prospective Phase I Study of GAX for Metastatic Pancreatic Cancer

Exclusion Criteria

• •1. Neuroendocrine cancer should be ruled out by histology or immunohistochemical staining of the specimen. Mixed histology, pancreatic neuroendocrine and adenocarcinoma tumors, will also be excluded.
• •2. Prior chemotherapy is allowed, as long as less than or equal to two of the components of GAX were used previously for their treatment: this includes gemcitabine, capecitabine, 5-FU, or ABRAXANE® .
• •3. Hypersensitivity: Patients with a history of severe hypersensitivity reaction to taxanes or other drugs formulated with polysorbate 80, or any of the other drugs in the GAX regimen are excluded.
• •4. Serious medical or psychiatric illness preventing informed consent or intensive treatment (e.g. serious infection) that would in the opinion of the investigator, increase the risk of serious neutropenic complications.
• •5. Serious medical risk factors involving any of the major organ systems, or serious psychiatric disorders, which could compromise the subject's safety or the study data integrity.
• •6. Patients with compromised immune systems who are at increased risk of toxicity and lethal infections when treated with marrow-suppressive therapy.
• •7. Serious cardiovascular thromboembolic disease, including: congestive heart failure NYHA class III or greater; unstable angina or new onset angina (starting within three months of screening for this protocol), or myocardial infarction within the past 3 months (prior to screening); serious cardiac arrhythmias requiring therapy; cerebrovascular accident including transient ischemic attacks within the past 3 months (prior to screening).
• •8. Serious non-healing wound, ulcer, or bone fracture.
• •9. Evidence or history of bleeding diathesis.
• •10. Major surgery, open biopsy or significant traumatic injury within 3 weeks of receiving first study drug.
• •11. Use of cytochrome P450 enzyme inducing drugs such as: antiepileptic drugs (phenytoin, carbamazepine, or phenobarbital, but not Keppra), or St. John's Wort or rifampin (rifampicin).
• •12. Prior malignancy in last 2 years other than curatively treated carcinoma in-situ of any site, non-melanoma skin cancer, or Stage I breast and/or bladder cancers (in situ), or early stage prostate cancer Stage I or II, curatively treated by surgery and/or radiation.
• •\-