S1201: Combination Chemo for Patients W/Advanced or Metastatic Esophageal, Gastric, or Gastroesophageal Junction Cancer
Condition: Adenocarcinoma of the Gastroesophageal Junction; Esophageal Cancer; Gastric Cancer
MeSH terms: Adenocarcinoma; Stomach Neoplasms; Esophageal Neoplasms
Intervention: FOLFOX regimen; docetaxel; fluorouracil; irinotecan hydrochloride; leucovorin calcium; oxaliplatin
Intervention description: Given IV. Fluorouracil, oxaliplatin, & leucovorin calcium.; 30 mg/m^2, IV over 30 minutes on Day 1,8 of each 21 day cycle.; 400 mg/m^2, IV bolus on Day 1 of each 14 day cycle; 2400 mg/m^2 IV over 46-48 hours on Days 1-2 of each 14 day cycle.; 65 mg/m^2, IV over 90 minutes on Days 1 & 8 of every 21 day cycle.; 400 mg/m^2, IV over 2 hours on Day 1 of every 14 day cycle.; 85 mg/m^2, IV over 2 hours on Day 1 of every 14 day cycle.
Intervention MeSH terms: Leucovorin; Docetaxel; Fluorouracil; Oxaliplatin; Irinotecan; Calcium; Levoleucovorin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 213.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: recurrent esophageal cancer; stage IV esophageal cancer; recurrent gastric cancer; stage IV gastric cancer; adenocarcinoma of the gastroesophageal junction; stage IIIB gastric cancer; stage IIIC gastric cancer; stage IIIB esophageal cancer; stage IIIC esophageal cancer; adenocarcinoma of the esophagus; adenocarcinoma of the stomach

Summary:

      RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin calcium, fluorouracil,
      irinotecan hydrochloride, and docetaxel, work in different ways to stop the growth of tumor
      cells, either by killing the cells or by stopping them from dividing. Combining more than one
      drug may kill more tumor cells. It is not yet known which regimen of combination chemotherapy
      is more effective in treating tumor cells.

      PURPOSE: This randomized phase II trial studies how well oxaliplatin, leucovorin calcium, and
      fluorouracil work compared to irinotecan hydrochloride and docetaxel in treating patients
      with esophageal cancer, gastric cancer, or gastroesophageal junction cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Patients must have unresectable advanced or metastatic histologically or cytologically
             confirmed adenocarcinoma of the esophagus, stomach, or gastroesophageal junction (GEJ)

               -  Patients must not have received treatment for metastatic or unresectable disease

               -  Patients must not have brain metastases

          -  Patients must have measurable and/or non-measurable disease

          -  Patients who have had HER-2 expression testing prior to patient consent to this study
             must be HER-2 negative; if HER-2 expression has not been tested prior to patient
             consent to this study, a second specimen must be submitted for HER-2 expression; if
             the specimen is HER-2 positive (or if HER-2 could not be evaluated), the patient will
             not be randomized

          -  Patients must have completed any prior neoadjuvant and adjuvant therapy for resectable
             disease at least 180 days prior to registration

        PATIENT CHARACTERISTICS:

          -  Zubrod performance status of 0-1

          -  Hemoglobin ≥ 9 g/dL

          -  Absolute neutrophil count (ANC) ≥ 1,500/mcL

          -  Platelets ≥ 100,000/mcL

          -  Total bilirubin ≤ 1.5 mg/dL regardless of whether patients have liver involvement
             secondary to tumor

          -  AST and ALT both ≤ 3 times institutional upper limit of normal (IULN) unless the liver
             is involved with tumor, in which case both AST and ALT must be ≤ 5 times IULN

          -  Serum creatinine < 1.5 mg/dL within 28 days prior to registration AND/OR calculated
             creatinine clearance > 60 mL/min

          -  Patients must not have motor or sensory neuropathy > Grade 1 using CTCAE version 4.0

          -  Patients must not be pregnant or nursing; women and men of reproductive potential must
             have agreed to use an effective contraceptive method

          -  No other prior malignancy is allowed except for the following: adequately treated
             basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated
             stage I or II cancer from which the patient is currently in complete remission, or any
             other cancer from which the patient has been disease-free for five years

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  All palliative radiation therapy alone must be completed at least 14 days prior to
             registration

          -  Patient must have no plans to receive concurrent chemotherapy, hormonal therapy,
             radiotherapy, immunotherapy, or any other type of therapy for treatment of cancer
             while on this protocol treatment