Pralatrexate and Oxaliplatin in Treating Patients With Unresectable or Metastatic Esophageal, Stomach, or Gastroesophageal Junction Cancer
Condition: Adenocarcinoma of the Gastroesophageal Junction; Esophageal Undifferentiated Carcinoma; Gastric Adenocarcinoma; Gastric Squamous Cell Carcinoma; Recurrent Esophageal Adenocarcinoma; Recurrent Esophageal Squamous Cell Carcinoma; Recurrent Gastric Carcinoma; Stage IIIB Esophageal Adenocarcinoma; Stage IIIB Esophageal Squamous Cell Carcinoma; Stage IIIB Gastric Cancer; Stage IIIC Esophageal Adenocarcinoma; Stage IIIC Esophageal Squamous Cell Carcinoma; Stage IIIC Gastric Cancer; Stage IV Esophageal Adenocarcinoma; Stage IV Esophageal Squamous Cell Carcinoma; Stage IV Gastric Cancer; Undifferentiated Gastric Carcinoma
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Adenocarcinoma; Stomach Neoplasms; Esophageal Squamous Cell Carcinoma; Esophageal Neoplasms; Recurrence
Intervention: Laboratory Biomarker Analysis; Oxaliplatin; Pralatrexate
Intervention description: Correlative studies; Given IV; Given IV
Intervention MeSH terms: Oxaliplatin; 10-deazaaminopterin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial studies how well pralatrexate and oxaliplatin work in treating patients
      with esophageal, stomach, or gastroesophageal junction cancer that cannot be removed by
      surgery or has spread from the primary site (place where it started) to other places in the
      body. Pralatrexate may stop the growth of tumor cells by blocking some of the enzymes needed
      for cell growth. Drugs used in chemotherapy, such as oxaliplatin, work in different ways to
      stop the growth of tumor cells, either by killing the cells, by stopping them from dividing,
      or by stopping them from spreading. Giving pralatrexate with oxaliplatin may be an effective
      treatment for esophageal, stomach, or gastroesophageal junction cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed carcinoma of the esophagus, stomach or gastro-esophageal
             junction that is metastatic, or locally advanced and inoperable for cure; histological
             sub-types permitted include adenocarcinoma, squamous-cell carcinoma, or
             undifferentiated carcinoma; small-cell carcinoma variant is not eligible

          -  No previous systemic therapy for metastatic or recurrent disease; therapy
             (chemotherapy, radiotherapy, or both) administered in the neo-adjuvant, adjuvant, or
             definitive setting for previously localized disease is permitted, provided it was
             completed more than 6 months prior to enrollment; palliative radiotherapy is permitted
             provided it is completed >= 3 weeks prior to study therapy initiation

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2

          -  Life expectancy >= 12 weeks

          -  Hemoglobin >= 9 g/dl

          -  Absolute neutrophil count >= 1500/mm^3

          -  Platelet count >= 100,000/mm^3

          -  Serum creatinine =< institutional upper limit normal (ULN)

          -  Bilirubin =< 1.5 x ULN

          -  Transaminases =< 3 x ULN; for documented liver metastases, transaminases up to 5 x ULN
             is permitted

          -  No evidence of >= grade 2 peripheral neuropathy

          -  Patients with reproductive potential must be willing to use an adequate contraceptive
             method (e.g., abstinence, intrauterine device, oral contraceptives, barrier device
             with spermicide or surgical sterilization) during treatment and for three months after
             completing treatment; a negative pregnancy test is required for women of child-bearing
             potential; nursing women are ineligible

          -  Written, informed consent

        Exclusion Criteria:

          -  Hypersensitivity to platinum compounds

          -  Uncontrolled inter-current illness including but not limited to active infection,
             symptomatic congestive heart failure, unstable angina, uncontrolled cardiac
             arrhythmia, or psychiatric illness that would limit compliance with study requirements

          -  Presence of brain metastases

          -  Patients with third-space (pleural, peritoneal) fluid not controllable with usual
             drainage methods are not eligible

          -  History of second primary malignancy within 3 years prior to enrollment, except for
             in-situ cervix carcinoma or non-melanoma skin cancer

          -  Undergone an allogeneic stem cell transplant