Clinical trial NCT00095966 (phase 2, status: completed)
Conditions: adenocarcinoma of the pancreas, recurrent pancreatic cancer, stage ii pancreatic cancer, stage iii pancreatic cancer, stage iv pancreatic cancer
ICD codes: C22.0, C22.1, C4A.9, C7B.1, D09.9, C4A.0, C4A.31, C25.3, C25.3, C25.3, C25.3
Drugs: sorafenib tosylate, gemcitabine hydrochloride
SMILES: CNC(=O)C1=NC=CC(OC2=CC=C(NC(=O)NC3=CC(=C(Cl)C=C3)C(F)(F)F)C=C2)=C1, NC1=NC(=O)N(C=C1)[C@@H]1O[C@H](CO)[C@@H](O)C1(F)F
Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed adenocarcinoma of the pancreas

               -  Locally advanced or metastatic disease

                    -  Locally advanced disease must extend outside the boundaries of a standard
                       radiotherapy port

          -  Not amenable to curative surgery or radiotherapy

          -  Measurable disease

               -  At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques
                  OR ≥ 10 mm by spiral CT scan

               -  Pleural effusion and ascites are not considered measurable lesions

               -  Outside prior radiotherapy port

          -  No known brain metastases

          -  Performance status - ECOG 0-1

          -  Performance status - Karnofsky 70-100%

          -  More than 3 months

          -  WBC ≥ 3,000/mm^3

          -  Absolute neutrophil count ≥ 1,500/mm^3

          -  Platelet count ≥ 100,000/mm^3

          -  No evidence of bleeding diathesis

          -  Bilirubin normal

          -  AST and/or ALT ≤ 2.5 times upper limit of normal

          -  Creatinine normal

          -  Creatinine clearance ≥ 60 mL/min

          -  No uncontrolled hypertension

          -  No symptomatic congestive heart failure

          -  No unstable angina pectoris

          -  No cardiac arrhythmia

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No active or ongoing infection

          -  No other active malignancy

          -  No history of allergic reaction attributed to compounds of similar chemical or
             biological composition to sorafenib or other study agents

          -  No psychiatric illness or social situation that would preclude study compliance

          -  No other uncontrolled illness

          -  No prior antiangiogenic agents

          -  No prior cytotoxic chemotherapy for metastatic disease

          -  At least 4 weeks since prior adjuvant chemotherapy (6 weeks for nitrosoureas or
             mitomycin) and recovered

          -  No prior gemcitabine

          -  See Disease Characteristics

          -  At least 4 weeks since prior radiotherapy and recovered

          -  No prior investigational drugs

          -  No prior sorafenib

          -  No prior MAPK signaling agents

          -  Concurrent warfarin anticoagulation allowed provided the following criteria are met:

               -  Therapeutic on a stable warfarin dose

               -  INR ≤ 3

               -  Undergo weekly INR testing

               -  No active bleeding or pathological condition that carries a high risk of bleeding

          -  No concurrent combination antiretroviral therapy for HIV-positive patients

          -  No other concurrent investigational agents

          -  No other concurrent anticancer therapies