Molecular Phenotyping in Predicting Response in Patients With Stage IB-III Esophageal Cancer Receiving Combination Chemotherapy
Condition: Stage IB Esophageal Adenocarcinoma; Stage IIA Esophageal Adenocarcinoma; Stage IIB Esophageal Adenocarcinoma; Stage IIIA Esophageal Adenocarcinoma; Stage IIIB Esophageal Adenocarcinoma; Stage IIIC Esophageal Adenocarcinoma
MeSH terms: Adenocarcinoma; Esophageal Neoplasms
Intervention: Paclitaxel; Carboplatin; Oxaliplatin; Leucovorin Calcium; Fluorouracil; Radiation Therapy; Therapeutic Conventional Surgery; Laboratory Biomarker Analysis
Intervention description: Given IV or IVPB; Given IV or IVPB; Given IV; Given IV; Given IV; Undergo radiation therapy; Undergo esophagectomy; Correlative studies
Intervention MeSH terms: Leucovorin; Paclitaxel; Carboplatin; Fluorouracil; Oxaliplatin; Calcium; Levoleucovorin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized pilot phase II trial studies how well molecular phenotyping works in
      predicting response in patients with stage IB-III esophageal cancer who are receiving
      carboplatin and paclitaxel or oxaliplatin, leucovorin calcium, and fluorouracil. Studying the
      genes in a patients tumor cells before and after chemotherapy may help in understanding if
      there are specific features of the tumor cells that make a person more or less likely to
      respond to treatment and how these features may be affected by treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have histologically or cytologically confirmed localized (T1N1-3M0 or
             T2-4NanyM0, stage IB-III) Siewert type 1 or type 2 esophageal adenocarcinoma that is
             amenable to surgical resection as determined by a thoracic surgeon and for which all
             disease (primary tumor and involved lymph nodes) can be treated with radiation, as
             determined by a radiation oncologist

          -  Patients may not have received any prior chemotherapy, biologic therapy or radiation
             therapy for management of their disease; chemotherapy or biologic therapy administered
             for treatment of another primary malignancy are permitted if treatment was greater
             than 5 years ago

          -  Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status =<
             2

          -  Patients must have a life expectancy of > 3 months, in the opinion of and as
             documented by the investigator

          -  Hemoglobin >= 10.0 g/dl

          -  Absolute neutrophil count >= 1,500/mcL

          -  Platelet count >= 100,000/mcL

          -  Total bilirubin within normal institutional limits

          -  Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) =<
             2.5 X institutional upper limit of normal

          -  Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 X
             institutional upper limit of normal

          -  Serum creatinine within normal institutional limits OR creatinine clearance >= 60
             mL/min/1.73 m^2 for patients with creatinine levels above institutional normal (as
             calculated by Cockcroft-Gault)

          -  Patients must have an avid primary tumor with an standardized uptake value (SUV) of >=
             5 on baseline (18F) FDG-PET/computed tomography (CT) imaging

          -  Men must agree to use adequate contraception (double barrier method of birth control
             or abstinence) 1 week prior to study entry, for the duration of study participation
             and for 1 month after completing combined modality treatment with chemotherapy and
             radiation; should a male patient's female partner become pregnant or suspect that she
             is pregnant while her partner is participating in this study, the treating physician
             should be informed immediately

          -  Patients must have the ability to understand and the willingness to sign a written
             informed consent document

          -  This study will be limited to enrollment of Caucasian males only

        Exclusion Criteria:

          -  Patients who are receiving any chemotherapy, biologic therapy, radiation therapy or
             any investigational agent

          -  Patients with metastatic disease

          -  Patients with a history of allergic reactions attributed to compounds of similar
             chemical or biologic composition to platinums, taxanes or fluoropyrimidines

          -  Patients who have previously received radiation therapy to the chest or abdomen such
             that there would be overlap between the previous and current radiation field

          -  Patients with uncontrolled intercurrent illness including, but not limited to ongoing
             or active infection, symptomatic congestive heart failure, unstable angina pectoris,
             cardiac arrhythmia, or psychiatric illness/social situations that would limit
             compliance with study requirements

          -  Patients with human immunodeficiency virus (HIV) whom are not receiving antiretroviral
             therapy

          -  Patients with another malignancy within the past 5 years