Clinical trial NCT00602602 (phase 2, status: completed)
Conditions: pancreatic cancer
ICD codes: C25.3
Drugs: fluorouracil, gemcitabine hydrochloride, oxaliplatin
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, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed adenocarcinoma of the pancreas

               -  Resectable, marginally resectable, or unresectable disease determined by one of
                  the following:

                    -  Contrast-enhanced helical-CT scan

                    -  Endoscopic ultrasound with biopsy (in patients who do not have metastatic or
                       grossly unresectable disease)

                    -  Dedicated pancreatic MRI

               -  Tumor must be locally advanced or potentially resectable, as determined by one of
                  the following:

                    -  Abutment of the portal or superior mesenteric veins, hepatic or superior
                       mesenteric artery

                    -  Extension to the origin of gastroduodenal artery

                    -  Occlusion of the superior mesenteric vein for < 2 cm

          -  Measurable disease, defined as ≥ 1 lesion that can be accurately measured in ≥ 1
             dimension (longest diameter to be recorded) as ≥ 20 mm by conventional techniques or ≥
             10 mm by spiral CT

               -  Marker elevation alone not allowed as justification for study entry

          -  Formalin-fixed, paraffin-embedded tumor tissue specimens from prior biopsy or surgical
             resection allowed for correlative studies

          -  No known brain metastases or tumor metastatic to the peritoneum, liver, or other
             organs

        PATIENT CHARACTERISTICS:

          -  ECOG performance status 0-1

          -  ANC ≥1,500/mm³

          -  Platelet count ≥ 100,000/mm³

          -  AST and ALT ≤ 2.5 times upper limit of normal (ULN)

          -  Creatinine < 1.5 times ULN

          -  Bilirubin < 2.0 mg/dL (≤ 10 mg/dL for patients with biliary obstruction by tumor)

               -  A biliary stent ≥ 9F or biliary bypass is required before treatment if there is
                  biliary obstruction by tumor

          -  Urine protein:creatinine ratio ≤ 1.0

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No significant traumatic injury within the past 28 days

          -  No serious non-healing wounds, ulcers, or bone fractures

          -  No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within
             the past 6 months

          -  No myocardial infarction, unstable angina, or cerebrovascular accident within the past
             6 months

          -  No NYHA class II-IV congestive heart failure

               -  Class II defined as symptoms of fatigue, dyspnea or other symptoms with ordinary
                  physical activity

          -  No clinically significant peripheral vascular disease

          -  Pre-existing hypertension allowed, provided that the patient is receiving a stable
             antihypertensive regimen and has a blood pressure ≤ 150/100 mm Hg at the time of
             enrollment

          -  Must have adequate oral intake of > 1500 calories/day and be able to maintain
             hydration OR have access for supplemental enteral feeding (nasoenteral tube, feeding
             jejunostomy, or percutaneous endoscopic gastrostomy tube)

        PRIOR CONCURRENT THERAPY:

          -  No prior chemotherapy or radiotherapy for pancreatic cancer

          -  More than 28 days since prior and no anticipated need for concurrent major surgical
             procedures

          -  More than 7 days since prior minor surgical procedures such as laparoscopy, fine
             needle aspirations, or core biopsies

          -  No treatment plan requiring treatment of > 50% of the liver at a dose > 30 Gy or > 50%
             of the total kidney volume at a dose > 18 Gy

          -  No concurrent combination antiretroviral therapy for HIV-positive patients

          -  No other concurrent investigational agents

          -  No oral or parenteral anticoagulation unless patients is receiving a stable dose of
             anticoagulant