Clinical trial NCT01298401 (phase 1, status: completed)
Conditions: pancreatic cancer
ICD codes: C25.3
Drugs: capecitabine, gemcitabine hydrochloride
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, NC1=NC(=O)N(C=C1)[C@@H]1O[C@H](CO)[C@@H](O)C1(F)F
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Pathologically confirmed (histologic or cytologic) locally advanced adenocarcinoma of
             the pancreas

               -  Patients must have unresectable disease based on institutional standardized
                  criteria of unresectability or medical inoperability

          -  Patients with or without regional adenopathy are eligible

          -  No distant metastases based upon the following minimum diagnostic workup:

               -  History and/or physical examination, including collection of weight and vital
                  signs, within 28 days prior to study entry

               -  Abdominal and/or pelvic CT scan with IV contrast or MRI scan within 21 days prior
                  to study entry

               -  Chest CT scan or whole-body PET/CT within 21 days prior to study entry

          -  No second malignancy or peritoneal seeding

        PATIENT CHARACTERISTICS:

          -  Zubrod performance status 0-1

          -  Absolute neutrophil count (ANC) ≥ 1,500/mm³

          -  Platelet count ≥ 100,000/mm³

          -  Hemoglobin (Hgb) ≥ 10.0 g/dL (the use of transfusion or other intervention to achieve
             Hgb ≥ 10.0 g/dL is acceptable)

          -  Glycosylated hemoglobin (HgbA1c) ≤ 8%

          -  Serum creatinine ≤ 1.5 mg/dL

          -  Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) < 3 times upper
             limit of normal (ULN)

          -  Total bilirubin < 3.0 mg/dL

          -  Alkaline phosphatase < 3 times ULN

          -  Fasting blood glucose < 160 mg/dL

               -  Patients with a non-fasting blood glucose > 160 mg/dL (8.9 mmol/L) must have a
                  fasting blood glucose ≤ 160 mg/dL (8.9 mmol/L) in order to be eligible

          -  No grade 2 or worse hearing impairment

          -  Negative serum pregnancy test (if applicable)

          -  Women of childbearing potential and men who are sexually active must be willing/able
             to use medically acceptable forms of contraception during the course of the study, and
             for 3 months (6 months for men) after the last study drug administration

          -  Not pregnant or nursing

          -  Ability to swallow oral medications

          -  At least 3 years since prior malignancy except non-melanomatous skin cancer or
             carcinoma in situ of the breast, oral cavity, or cervix

          -  No severe active co-morbidity, defined as any of the following:

               -  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

               -  Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease
                  Control and Prevention (CDC) definition

                    -  HIV testing is not required for entry into this protocol

               -  Existing venous thromboembolism requiring anti-coagulation therapy

          -  No prior allergic reaction to capecitabine or gemcitabine hydrochloride

        PRIOR CONCURRENT THERAPY:

          -  No prior systemic chemotherapy for pancreatic cancer

               -  Prior chemotherapy for malignancies other than pancreatic cancer is allowed
                  provided chemotherapy was completed > 3 years prior to study entry

          -  No prior radiotherapy to the region of the study cancer that would result in overlap
             of radiation therapy fields

          -  More than 28 days since any prior major surgery

               -  Insertion of a vascular access device, insertion of a biliary stent, exploratory
                  laparotomy, or laparoscopy are not considered major surgery

          -  No prior ganitumab

          -  Patients requiring concurrent oral anticoagulants (e.g., Coumadin, warfarin) are
             eligible provided there is increased vigilance with respect to monitoring
             international normalized ratio (INR)

          -  No concurrent participation in another clinical treatment trial

          -  No concurrent intensity-modulated radiotherapy

          -  No other concurrent therapy including the following:

               -  Other investigational or approved chemotherapeutic agents

               -  Other monoclonal antibody

               -  Sorivudine or brivudine A

               -  Cimetidine

               -  G-CSF agents