Phase II Study Using CHFR Methylation Status in Patients With Metastatic Esophageal, Gastroesophageal, Gastric Cancer.
Condition: Metastatic Esophageal Cancer; Gastroesophageal Cancer; Gastric Cancer
MeSH terms: Stomach Neoplasms
Intervention: Docetaxel; Leucovorin; Fluorouracil; Cisplatin
Intervention description: Modified Docetaxel 40mg/m2 on Day 1; Leucovorin 400mg/m2 on Day 1; Fluorouracil 400mg/m2 on Day 1 Fluorouracil 1000mg/m2/day on Days 1 and 2; Cisplatin (or Carboplatin) 40mg/m2 on Day 3
Intervention MeSH terms: Leucovorin; Carboplatin; Docetaxel; Fluorouracil
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      To estimate and compare the response rates in patients treated with mDCF based on methylation
      status of CHFR.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have metastatic disease of the esophagus, gastroesophageal junction or
             stomach. Patients with locally recurrent disease who are not deemed eligible for
             radiation are also permitted.

          -  Histological, cytologic or radiographic documentation of metastatic adenocarcinoma or
             squamous cell carcinoma of the esophagus, gastroesophageal junction or stomach.
             Radiologic, endoscopic, histologic or cytologic evidence of locally recurrent disease
             is also permitted.

          -  Patients must be untreated with chemotherapy for metastatic or locally recurrent
             disease. Prior radiation therapy is permitted.

          -  Patients must have measurable disease as per RECIST 1.1, defined as at least one
             lesion that can be accurately measured in at least one dimension (longest diameter to
             be recorded for non-nodal lesions and short axis for nodal lesions) as >20 mm with
             conventional techniques or as >10 mm with spiral CT scan, MRI, or calipers by clinical
             exam. See Section 11 for the evaluation of measurable disease.

          -  Age >18 years and ≤ 80 years.

          -  ECOG performance status <2 (Karnofsky >60%, see Appendix A).

          -  Life expectancy of greater than 3 months.

          -  Patients must have normal organ and marrow function.

          -  Patients must not have any of the following conditions:

          -  Recent major surgery, hormonal therapy (other than replacement) or chemotherapy,
             within 4 weeks prior to entering the study or those who have not recovered from the
             adverse events of treatment.

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to the chemotherapy on this trial.

          -  Ability to understand and the willingness to sign a written informed consent document.

        Exclusion Criteria:

          -  Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for
             nitrosoureas or mitomycin C) prior to entering the study or those who have not
             recovered from adverse events due to agents administered more than 4 weeks earlier.

          -  Patients who are receiving any investigational agents.

          -  Patients with known brain metastases should be excluded from this clinical trial
             because of their poor prognosis and because they often develop progressive neurologic
             dysfunction that would confound the evaluation of neurologic and other adverse events.

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to the chemotherapy used in the study.

          -  Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, phenobarbital,
             or St John's Wort; these drugs induce CYP3A and may decrease levels of taxanes. 5-FU
             is a strong CYP2C9 inducer, and concomitant use with carvedilol, celecoxib,
             fosphenytoin, fluoxetine, phenytoin, warfarin and other CYP2C9 substrates should be
             used with caution.

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, unstable
             cardiac arrhythmia, or psychiatric illness/social situations that would limit
             compliance with study requirements.

          -  Pregnant women are excluded from this study because chemotherapy has the potential for
             teratogenic or abortifacient effects.

          -  HIV-positive patients on combination antiretroviral therapy are ineligible because of
             the potential for pharmacokinetic interactions with chemotherapeutic agents. In
             addition, these patients are at increased risk of lethal infections when treated with
             marrow-suppressive therapy. Appropriate studies will be undertaken in patients
             receiving combination antiretroviral therapy when indicated.