Phase II Study of Oxaliplatin, Irinotecan, and Capecitabine in Advanced Gastric/Gastroesophageal Junction Carcinoma
Condition: Adenocarcinoma of the Gastroesophageal Junction; Diffuse Adenocarcinoma of the Stomach; Intestinal Adenocarcinoma of the Stomach; Mixed Adenocarcinoma of the Stomach; Recurrent Gastric Cancer; Stage IIIA Gastric Cancer; Stage IIIB Gastric Cancer; Stage IIIC Gastric Cancer; Stage IV Gastric Cancer
MeSH terms: Adenocarcinoma; Stomach Neoplasms
Intervention: oxaliplatin; irinotecan hydrochloride; capecitabine
Intervention description: Given IV; Given IV; Given orally
Intervention MeSH terms: Capecitabine; Oxaliplatin; Irinotecan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 39.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Drugs used in chemotherapy, such as oxaliplatin, irinotecan, and capecitabine, work in
      different ways to stop tumor cells from dividing so they stop growing or die. Giving more
      than one chemotherapy drug may kill more tumor cells. This phase II trial is studying how
      well giving oxaliplatin together with irinotecan and capecitabine works in treating patients
      with metastatic or inoperable locally advanced gastric cancer or gastroesophageal junction
      adenocarcinoma (cancer).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have histologically or cytologically confirmed gastric adenocarcinoma or
             adenocarcinoma of the gastroesophageal junction. Patients must have metastatic or
             inoperable locally advanced disease; GE Junction tumor location should be documented
             in the patient's medical record chart using the Siewert classification below:

               -  Type I: Adenocarcinoma of the distal esophagus which usually arises from an area
                  with specialized intestinal metaplasia of the esophagus and which may infiltrate
                  the GE junction from above Type II: True carcinoma of the cardia arising from the
                  cardiac epithelium or short segments with intestinal metaplasia at the GE
                  junction Type III: Subcardial gastric carcinoma which infiltrates the GE junction
                  and distal esophagus from below

          -  Patients must have measurable disease, defined as at least one lesion that can be
             accurately measured in at least one dimension (longest diameter to be recorded) as >=
             20 mm with conventional techniques or as >= 10 mm with spiral CT scan

          -  No prior chemotherapy for metastatic or recurrent disease is allowed; one course of
             neoadjuvant chemotherapy and/or adjuvant chemotherapy with or without radiation
             therapy as primary treatment is acceptable; at least 4 weeks must have elapsed since
             prior radiation therapy; patients must have been off previous anti-cancer therapy for
             at least 4 weeks

          -  Life expectancy of >= 12 weeks

          -  ECOG performance status 0-2

          -  Hemoglobin >= 9.5 g/dL

          -  Absolute neutrophil count >= 1,500/uL

          -  Platelets >= 100,000/uL

          -  Total bilirubin =< 1.5 mg/dL

          -  Creatinine =< 1.5 mg/dL OR creatinine clearance >= 60 mL/min/1.73 m^2 for patients
             with creatinine levels above institutional normal

          -  The effects of oxaliplatin, irinotecan, and capecitabine on the developing human fetus
             at the recommended therapeutic dose are unknown; for this reason and because these
             drugs are known to be teratogenic, women of child-bearing potential and men must agree
             to use adequate contraception (hormonal or barrier method of birth control;
             abstinence) prior to study entry and for the duration of study participation; should a
             woman become pregnant or suspect she is pregnant while participating in this study,
             she should inform her treating physician immediately

          -  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 prior to entering
             the study or those who have not recovered from adverse events due to agents
             administered more than 4 weeks earlier

          -  Patients may not be receiving any other 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;
             patients should have no greater than grade 2 neuropathy

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to oxaliplatin, irinotecan and capecitabine

          -  Patients with NYHA classification III or IV heart disease are ineligible

          -  Patients must not have a known hypersensitivity to 5-fluorouracil

          -  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

          -  Pregnant women are excluded from this study because the study drugs have the potential
             to cause teratogenic or abortifacient effects; because there is an unknown but
             potential risk for adverse events in nursing infants secondary to treatment of the
             mother with the study drugs, breastfeeding should be discontinued if the mother is
             treated with oxaliplatin, irinotecan or capecitabine

          -  Patients with immune deficiency are at increased risk of lethal infections when
             treated with marrow-suppressive therapy; therefore, HIV-positive patients receiving
             combination anti-retroviral therapy are excluded from the study because of possible
             pharmacokinetic interactions with the study drugs; appropriate studies will be
             undertaken in patients receiving combination anti-retroviral therapy when indicated

          -  Patients who are unable to take oral medications are not eligible