Pralatrexate and Docetaxel in Treating Patients With Stage IV Esophageal or Gastroesophageal Cancer Who Have Failed Platinum-Based Therapy
Condition: Adenocarcinoma of the Esophagus; Adenocarcinomas of the Gastroesophageal Junction; Recurrent Esophageal Cancer; Squamous Cell Carcinoma of the Esophagus; Stage IV Esophageal Cancer
MeSH terms: Carcinoma; Adenocarcinoma; Esophageal Neoplasms; Esophageal Squamous Cell Carcinoma
Intervention: pralatrexate; docetaxel; fludeoxyglucose F 18; positron emission tomography
Intervention description: IVP(intravenous push)over 3-5 minutes on day 1 at a dose of 120 mg/m2.; Given Intravenous Piggyback (IVPB)as one-hour infusion at a dose of 3 mg/m2 on day 1 of a cycle. cycle defined as 14 days.; Correlative studies; Correlative studies
Intervention MeSH terms: Deoxyglucose; Docetaxel; Fluorodeoxyglucose F18
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Gastroesophageal Cancer; Gastroesophageal Carcinoma; Adenocarcinoma

Summary:

      RATIONALE: Pralatrexate may stop the growth of tumor cells by blocking some of the enzymes
      needed for cell growth. Drugs used in chemotherapy, such as docetaxel, work in different ways
      to stop the growth of tumor cells, either by killing the cells or by stopping them from
      dividing. Giving pralatrexate together with docetaxel may kill more tumor cells.

      PURPOSE: This phase II trial is studying how well giving pralatrexate together with docetaxel
      works in treating patients with stage IV esophageal or gastroesophageal cancer who have
      failed platinum-based therapy.
    

Eligibility criteria:

        Inclusion

          -  Pathologically confirmed unresectable advanced or metastatic carcinoma of the
             esophagus or gastroesophageal junction

          -  Established histological confirmation of squamous cell carcinoma or adenocarcinoma of
             the esophagus or gastroesophageal junction

          -  Stage IV disease

          -  Must have received platinum-based therapy; this includes definitive, adjuvant and
             metastatic treatments

          -  No more than 3 chemotherapeutic treatment regimens permitted; this includes concurrent
             chemoradiation

          -  Radiation therapy allowed if > 4 weeks have elapsed

          -  Must be off therapy for 4 weeks prior to enrollment

          -  Measurable disease as defined by RECIST v 1.1 criteria

          -  ECOG (Eastern Cooperative Oncology Group)PS(Performance status)of 0 to 2

          -  Predicted life expectancy of at least 12 weeks

          -  Patients with reproductive potential must use an effective method to avoid pregnancy
             for the duration of the trial and for three months after completion of treatment

          -  Marrow: ANC(absolute neutrophil count)> 1,000/mm^3

          -  Marrow: Hemoglobin > 9.0 g/dl

          -  Marrow: Platelet Count > 100,000/mm^3

          -  Renal: Serum creatinine =< 1.5 g/dL

          -  Hepatic: Serum bilirubin < 1.5 x ULN(upper limit of normal) and AST (aspartate
             aminotransferase) and ALT (Alanine aminotransferase)=< 2.5 x ULN

          -  Prior minor surgeries (such as laparoscopies) must have occurred at least 14 days
             prior to study enrollment; prior minor procedures such as biopsies and mediport
             placement must have occurred at least 48 hours prior to study enrollment

          -  All patients must have signed an informed consent indicating that they are aware of
             the neoplastic nature of their disease and have been informed of the procedures of the
             protocol, the experimental nature of the therapy, alternatives, potential benefits,
             side effects, risks, and discomforts

          -  History of allergic reactions attributed to compounds of similar chemical composition
             to agents used in the study

        Exclusion

          -  Pregnant or lactating women

          -  Patients with any severe concurrent disease which, in the judgment of the
             investigator, would make the patient inappropriate for study entry

          -  Any malignant condition for which one has received treatment in the last two years
             excluding squamous or basal cell carcinomas

          -  Patients with untreated brain metastases

          -  Patients must not have grade 2 or higher baseline peripheral neuropathy, according to
             CTCAE v 4.0

          -  Patients must have NO continuing acute toxic effects (except alopecia) of any prior
             radiotherapy, chemotherapy, or surgical procedures; all such effects must have
             resolved to Common Terminology Criteria for Adverse Events (CTCAE v 4.0) Grade =< 1
             prior to study enrollment