Saracatinib in Treating Patients With Locally Advanced or Metastatic Stomach or Gastroesophageal Junction Cancer
Condition: Adenocarcinoma of the Gastroesophageal Junction; Adenocarcinoma of the Stomach; Recurrent Gastric Cancer; Stage III Gastric Cancer; Stage III Esophageal Cancer; Stage IV Esophageal Cancer; Stage IV Gastric Cancer
MeSH terms: Adenocarcinoma; Stomach Neoplasms; Esophageal Neoplasms
Intervention: saracatinib
Intervention description: Patients receive AZD0530 (saracatinib) PO QD in the absence of disease progression or unacceptable toxicity.
Intervention MeSH terms: Saracatinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial is studying how well saracatinib works in treating patients with locally
      advanced or metastatic stomach or gastroesophageal junction 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 stomach or
             gastroesophageal junction (GEJ)

               -  Tumors of the GEJ must be sub-specified as type I, II, or III using the Siewert
                  classification

          -  Metastatic or locally advanced disease

               -  Patients with local/regional disease only, must have unresectable disease

          -  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
             as ≥ 10 mm by spiral computed tomography (CT) scan

          -  No known brain metastases

          -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2 OR Karnofsky PS
             60-100%

          -  Life expectancy > 3 months

          -  Platelet count ≥ 100,000/mm³

          -  Leukocytes ≥ 3,000/mm³

          -  Absolute neutrophil count ≥ 1,500/mm³

          -  Hemoglobin > 9 g/dL

          -  Total bilirubin normal

          -  Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 2.5 times upper
             limit of normal

          -  Creatinine normal OR creatinine clearance ≥ 60 mL/min

          -  Urine protein creatinine ratio < 1.0 OR urine protein < 1,000 mg by 24-hour urine
             collection

        Exclusion Criteria:

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No condition that potentially impairs the ability to swallow or absorb AZD0530,
             including any of the following:

               -  Gastrointestinal tract disease resulting in an inability to take oral medication
                  or a requirement for IV alimentation

               -  Active peptic ulcer disease

               -  Short gut syndrome

               -  Malabsorption syndrome of any type

               -  Total or partial bowel obstruction

               -  Inability to tolerate oral medications

          -  No history of allergic reactions attributed to compounds of similar chemical or
             biologic composition to AZD0530

          -  No QTc prolongation (defined as a QTc interval ≥ 460 msec) or other significant
             electrocardiogram (ECG) abnormalities

          -  No poorly controlled hypertension (i.e., systolic blood pressure [BP] ≥ 140 mm Hg or
             diastolic BP ≥ 90 mm Hg)

          -  No history of ischemic heart disease, including myocardial infarction

          -  No concurrent cardiac dysfunction including, but not limited to, any of the following:

               -  Symptomatic congestive heart failure

               -  Unstable angina pectoris

               -  Cardiac arrhythmia

          -  No other concurrent uncontrolled illness, including ongoing or active infection or
             psychiatric illness/social situations, that would limit compliance with study
             requirements

          -  Prior chemotherapy allowed provided it was administered as part of initial curative
             intent therapy (i.e., neoadjuvant therapy, adjuvant therapy and/or concurrently with
             radiotherapy) in combination with surgery

               -  At least 4 weeks since prior chemotherapy

          -  At least 4 weeks since prior and no more than 1 line of palliative chemotherapy for
             advanced disease

          -  At least 4 weeks since prior radiotherapy and recovered

          -  At least 4 weeks since prior major surgery and recovered

          -  No cytochrome 450 3A4 (CYP3A4) active agents or substances for ≥ 7 days before,
             during, and for ≥ 7 days after completion of study treatment

          -  No other concurrent investigational agents

          -  No other concurrent anticancer therapy

          -  No concurrent combination antiretroviral therapy for human immunodeficiency virus
             (HIV)-positive patients