Clinical trial NCT00397787 (phase 2, status: completed)
Conditions: acinar cell adenocarcinoma of the pancreas, duct cell adenocarcinoma of the pancreas, recurrent pancreatic cancer, stage iv pancreatic cancer
ICD codes: C22.0, C4A.9, C7B.1, C4A.0, C4A.31, C4A.51, C4A.8, C22.0, C4A.9, C7B.1, C4A.0, C4A.31, C4A.51, C4A.8, C25.3, C25.3
Drugs: sunitinib malate
SMILES: CCN(CC)CCNC(=O)C1=C(C)NC(\C=C2/C(=O)NC3=C2C=C(F)C=C3)=C1C
Eligibility criteria:

        Inclusion Criteria:

          -  Histologic or cytologic documentation of pancreatic adenocarcinoma with evidence of
             disease progression following first-line therapy is required

          -  No brain metastases

          -  Patients with measurable disease

               -  Lesions that can be accurately measured in at least one dimension (longest
                  diameter to be recorded as >= 20 mm with conventional techniques or as>= 10 mm
                  with spiral computed tomography (CT) scan; of particular note, the primary
                  pancreatic tumor does not constitute measurable disease; therefore, patients with
                  locally advanced pancreatic cancer as the sole site of disease are not eligible

          -  Patients must have received one of the following prior therapies containing
             gemcitabine:

               -  One and only one prior therapy for metastatic disease with gemcitabine, or a
                  gemcitabine-containing cytotoxic combination, or

               -  One prior chemoradiation therapy containing gemcitabine for inoperable locally
                  advanced pancreatic cancer, as long as the patient has subsequently progressed
                  and has measurable disease outside a radiation port, or

               -  One prior adjuvant chemotherapy regimen or chemoradiation therapy containing
                  gemcitabine if the patient subsequently progressed within 3 months of completion
                  of adjuvant therapy; patients who have received chemoradiation in the adjuvant
                  setting must have measurable disease outside the radiation port

          -  No prior therapy with any other antiangiogenic agent (e.g., bevacizumab, sorafenib,
             pazopanib, AZD2171, PTK787, VEGF Trap, etc.)

          -  At least 4 weeks must have elapsed prior to initiation of treatment since the
             completion of chemotherapy and/or radiation therapy

          -  At least 4 weeks must have elapsed prior to registration since any major surgery

          -  Prior erlotinib is permitted; the last dose must have been administered 14 or more
             days prior to initiation of treatment; all erlotinib related side effects must have
             resolved to < grade 1 prior to registration

          -  No significant cardiac disease including:

               -  QTc prolongation (defined as a QTc interval equal to or greater than 500 msec) or
                  other significant EKG abnormalities

               -  History of myocardial infarction, cardiac arrhythmia, stable/unstable angina,
                  symptomatic congestive heart failure, or coronary/peripheral artery bypass graft
                  or stenting within 12 months prior to registration

               -  History of class III or IV heart failure within 12 months prior to registration
                  as defined by the NYHA functional classification system

          -  In addition, patients with history of hypertension must be well controlled (< 140/90)
             on a regimen of anti-hypertensive therapy

          -  Patients with a history of hypothyroidism are eligible, provided they are currently
             euthyroid

          -  The use of inhibitors and inducers of CYP3A4 is not permitted:

               -  The following inhibitors of CYP3A4 is prohibited within 7 days before beginning
                  and during treatment with sunitinib:

                    -  Azole antifungals (ketoconazole, itraconazole)

                    -  Diltiazem

                    -  Clarithromycin

                    -  Erythromycin

                    -  Verapamil

                    -  Delavirdine

                    -  HIV protease inhibitors (indinavir, saquinavir, ritonavir, atazanavir,
                       nelfinavir)

               -  The following inducers of CYP3A4 are prohibited within 12 days before beginning
                  and during treatment with sunitinib:

                    -  Rifampin

                    -  Rifabutin

                    -  Carbamazepine

                    -  Phenobarbital

                    -  Phenytoin

                    -  St. John's wort

                    -  Efavirenz

                    -  Tipranavir

               -  Other inhibitors or inducers of CYP3A4 may be used if necessary, but their use is
                  discouraged

          -  The use of agents with proarrhythmic potential (e.g., quinidine, procainamide,
             disopyramide, sotalol, probucol, bepridil, haloperidol, risperidone, indapamide,
             flecainide) is not permitted during the study

          -  ECOG performance status 0-2

          -  No history of cerebrovascular accident (CVA) or transient ischemic attack within 12
             months prior to registration

          -  No history of pulmonary embolism within the past 6 months

          -  Patients who require use of therapeutic doses of coumadin-derivative anticoagulants
             such as warfarin are excluded, although doses of up to 2 mg daily are permitted for
             prophylaxis of thrombosis; Note: Low molecular weight heparin is permitted provided
             the patient's PT INR is < 1.5

          -  No serious or non-healing wound, ulcer, or bone fracture

          -  No history (within 6 months) of significant bleeding events (e.g., upper or lower GI
             bleeding, hemoptysis, or hematuria), abdominal fistula, gastrointestinal perforation,
             or intra-abdominal abscess within 28 days of treatment

          -  No evidence of duodenal invasion by the tumor on CT scan

          -  No "currently active" second malignancy other than non-melanoma skin cancers; patients
             are not considered to have a "currently active" malignancy if they have completed
             therapy and are considered by their physician to be at less than 30% risk of relapse

          -  Non-pregnant and not breast feeding; pregnant women are excluded from this study
             because sunitinib is an antiangiogenic agent with the potential for teratogenic or
             abortifacient effects; because there is an unknown but potential risk for adverse
             events in nursing infants secondary to treatment of the mother with sunitinib,
             breastfeeding should be discontinued if the mother is treated with sunitinib malate

          -  ANC >= 1,500/μl

          -  Platelet count >= 100,000/μl

          -  Bilirubin < 1.5 mg/dL

          -  PT and PTT =< 1.5 X ULN

          -  Creatinine =< 1.5 mg/dL

          -  AST (SGOT) =< 2.5 X ULN if no liver metastases (=< 5 X ULN if liver metastases)