Saracatinib in Treating Patients With Previously Treated Metastatic Pancreatic Cancer
Condition: Adenocarcinoma of the Pancreas; Recurrent Pancreatic Cancer; Stage IV Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: saracatinib; pharmacogenomic studies; pharmacological study; positron emission tomography; fludeoxyglucose F 18; laboratory biomarker analysis
Intervention description: Given PO; Optional correlative studies; Optional correlative studies; Optional correlative studies; Optional correlative studies; Optional correlative studies
Intervention MeSH terms: Saracatinib; Fluorodeoxyglucose F18
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial is studying how well saracatinib works in treating patients with
      previously treated metastatic pancreatic cancer. Saracatinib may stop the growth of tumor
      cells by blocking some of the enzymes needed for cell growth.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed adenocarcinoma of the pancreas

               -  Metastatic disease

          -  Received ≥ 1 prior chemotherapy regimen, preferably gemcitabine hydrochloride-based

          -  Biomarker screening portion of study:

               -  For subjects without archival tissue available (core biopsy or resection
                  specimen; fine-needle aspirate samples only are not sufficient), must be willing
                  to undergo a fresh needle-core biopsy of a safely biopsiable metastasis

          -  No known brain metastases

          -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2 OR Karnofsky PS
             60-100%

          -  White blood cell (WBC) ≥ 3,000/mm³

          -  Absolute neutrophil count (ANC) ≥ 1,500/mm³

          -  Platelet count ≥ 100,000/mm³

          -  Hemoglobin ≥ 9 g/dL

          -  Total bilirubin < 1.5 times upper normal limit (ULN) (patients may have been shunted
             in order to achieve normal bilirubin level)

          -  Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 2.5 times ULN (<
             5 times ULN for patients with liver metastases)

          -  Creatinine normal OR creatinine clearance ≥ 60 mL/min

          -  Urine protein < 1,000 mg

          -  Urine protein: creatinine ratio ≤ 1.0

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  Asymptomatic human immunodeficiency virus (HIV) allowed

          -  Willingness to undergo 2 tumor biopsies

          -  No history of allergic reactions attributed to compounds of similar chemical or
             biological composition to AZD0530

          -  No prolonged QTc interval (i.e., ≥ 480 msec)

          -  No other significant electrocardiogram (ECG) abnormalities

          -  No poorly controlled hypertension (i.e., systolic blood pressure [BP] ≥ 150 mm Hg or
             diastolic BP ≥ 90 mm Hg)

          -  No concurrent cardiac dysfunction including, but not limited to, any of the following:

               -  History of ischemic heart disease

               -  Myocardial infarction

               -  Symptomatic congestive heart failure

               -  Unstable angina pectoris

               -  Cardiac arrhythmia

          -  No condition (e.g., gastrointestinal tract disease resulting in an inability to take
             oral medication or requirement for intravenous (IV) alimentation, prior surgical
             procedures affecting absorption, or active peptic ulcer disease) that impairs ability
             to swallow AZD0530 tablets

          -  No uncontrolled concurrent illness including, but not limited to any of the following:

               -  Ongoing or active infection

               -  Psychiatric illness or social situations that would limit compliance with study
                  requirements

          -  No other malignancy within the past 5 years, except curatively treated basal cell
             carcinoma of the skin or carcinoma in situ of the cervix

          -  Recovered from all prior therapy (< grade 2) (excluding alopecia) administered within
             the past 4 weeks

          -  At least 3 weeks since prior chemotherapy (6 weeks for carmustine or mitomycin)

          -  At least 4 weeks since prior radiotherapy

          -  More than 7 days since prior and no concurrent cytochrome P450 3A4 (CYP3A4)-active
             agents

          -  No ongoing adverse events (excluding alopecia) due to chemotherapy or radiotherapy
             given more than 4 weeks prior to study

          -  No other concurrent investigational agents

          -  No concurrent combination antiretroviral therapy for HIV-positive patients

          -  Concurrent low molecular weight heparin or full-dose coumadin allowed

          -  Concurrent therapeutic hematopoietic growth factors allowed