FDG-PET Directed Treatment in Improving Response in Patients With Locally Advanced Stomach or Gastroesophageal Junction Cancer
Condition: Adenocarcinoma of the Gastroesophageal Junction; Gastric Adenocarcinoma; Gastric Cancer
MeSH terms: Adenocarcinoma; Stomach Neoplasms
Intervention: FDG-PET; surgery; 5-FU; capecitabine; docetaxel; Irinotecan; 3D-CRT; IMRT
Intervention description: 200 mg/m^2/day IV; oral 800 mg/m^2 BID; 30 mg/m^2 IV; 50 mg/m^2 IV
Intervention MeSH terms: Docetaxel; Capecitabine; Irinotecan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized phase II trial studies how well fludeoxyglucose F-18 (FDG)/positron emission
      tomography (PET) directed treatment improves response in patients with stomach or
      gastroesophageal junction cancer that has not spread past the stomach and is not responding
      to the usual treatment. PET scans are a different way to take pictures of cancer and can be
      used to look at how much energy (such as glucose) is being used by the cancer. Using PET
      scans early to monitor the success of treatment may allow doctors to measure response and
      change treatment accordingly.
    

Eligibility criteria:

        Pre-Registration Eligibility Criteria

          1. Documentation of Disease

             1.1 Histologically confirmed adenocarcinoma of the stomach or gastroesophageal
             junction (Siewert type II, III)

             1.2 Pre-treatment clinical stage of T3-4N any M0 or T any N positive M0 as determined
             by laparoscopy, CT scan (or PET/CT), or endoscopic ultrasound (histologic confirmation
             of lymph involvement is not required). Therefore, patients can have measurable or
             non-measurable disease.

             1.3 Patients with T1-2N0M0 tumors or patients with metastatic disease are NOT
             eligible.

          2. Patients must be eligible for curative intent surgical resection.

          3. FDG Avid malignancy - Patients must have an FDG avid tumor(s). FDG avid tumors are
             defined as a primary tumor with an increased uptake in the region of the tumor that
             has an SUV of > 5.0 or a tumor:liver SUV ratio of > 1.5.

          4. No prior history of congestive heart failure - NYHA class I to IV or known DPD
             deficiency

          5. No current grade 2, 3, or 4 of neuropathy.

          6. No known hypersensitivity to epirubicin, oxaliplatin and cisplatin, capecitabine and
             5-flurouracil, docetaxel or irinotecan.

          7. Not pregnant and not nursing, because this study involves an agent that has known
             genotoxic, mutagenic and teratogenic effects.

             7.1 Therefore, for women of childbearing potential only, a negative serum pregnancy
             test pregnancy test done ≤ 7 days prior to pre-registration is required.

             7.2 A female of childbearing potential is a sexually mature female who: 1) has not
             undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally
             postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in
             the preceding 12 consecutive months).

          8. Age ≥ 18 years

          9. ECOG Performance Status 0 or 1

         10. Required Initial Laboratory Values:

               -  Absolute Neutrophil Count (ANC) ≥ 1,500/mm^3

               -  Platelet Count ≥ 100,000/mm^3

               -  Creatinine ≤ 1.5 x upper limit of normal (ULN)

               -  Total Bilirubin ≤ 1.5 x ULN, except in patients with Gilbert's disease

               -  AST and ALT ≤ 2.5 x ULN

               -  Alkaline Phosphatase ≤ 2.5 x ULN

        Registration Eligibility Criteria to Treatment Arms A or B

          1. Patient must continue to be eligible for curative intent surgical resection.

          2. Disease Progression: FDG avid malignancy that is classified as an FDG PET non-
             responder. PET non-responders are defined as having < 35% reduction in the FDG uptake
             of the primary tumor when compared to baseline.

          3. Concomitant Medications -

             3.1 Chronic concomitant treatment with strong inhibitors of CYP3A4 is not allowed on
             this trial. Patients on strong CYP3A4 inhibitors must discontinue the drug 14 days
             prior to the start of study treatment.

             3.2 Chronic concomitant treatment with strong CYP3A4 inducers is not allowed. Patients
             must discontinue the drug 14 days prior to the start of study treatment.

          4. Patient must have received only one cycle of the following regimens during the
             pre-registration time period and no other therapy for gastric or gastroesophageal
             junction cancer:

               -  Epirubicin, Oxaliplatin, and Capecitabine

               -  Epirubicin, Oxaliplatin, and Fluorouracil

               -  Epirubicin, Cisplatin, and Capecitabine

               -  Epirubicin, Cisplatin, and Fluorouracil

          5. Toxicity recovery should include the following:

               -  Grade ≤ 2 neuropathy

               -  Grade ≤ 2 diarrhea

               -  Grade ≤ 2 mucositis

          6. Pre-registration chemotherapy given within 42 days of treatment (treatment meaning
             surgery if Arm A, chemotherapy if Arm B)