Biweekly SOLAR, as First-line C/T in Pts With Gastric, Pancreatic and Biliary Cancers
Condition: Gastric Cancer in Situ; Pancreatic Cancers; Biliary Cancers
MeSH terms: Biliary Tract Neoplasms; Carcinoma in Situ
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of the study is to determine the maximal tolerated dose (MTD) of
      Oxaliplatin in this phase I study. The secondary objectives are to determine the response
      rate, progression free survival, overall survival, and safety profiles.

      Eligible patients will receive a triplet chemotherapy consisting of nab-paclitaxel
      (Abraxane®) 150 mg/m2 IVD 30 min followed by Oxaliplatin 60 - 85 mg/m2 IVD 2hr at D1, plus
      oral S-1 35mg/m2 and Leucovorin 30mg twice daily from D1 to D7, every 14 days as a cycle till
      disease progression.
    

Detailed description: 
      Eligible patients will receive a triplet chemotherapy consisting of nab-paclitaxel
      (Abraxane®) 150 mg/m2 IVD 30 min followed by Oxaliplatin 60 - 85 mg/m2 IVD 2hr at D1, plus
      oral S-1 35mg/m2 and Leucovorin 30mg twice daily from D1 to D7, every 14 days as a cycle till
      disease progression.

      In this study (a standard 3 x 3 design), patients will be enrolled in cohort of 3 to receive
      escalating dose of Oxaliplatin at three dose levels (level I, 60 mg/m2, level II, 75 mg/m2
      and level III, 85 mg/m2). Intra-patient dose escalation will not be allowed. If none of the
      first 3 patients of a cohort experiences a dose limiting toxicity (DLT), then dose escalation
      will proceed for next cohort of patients. If 1 of 3 patients developed DLT, the cohort will
      be expanded to 6 patients. If ≤2 patients of the 6 patients experience DLT, then dose
      escalation will proceed in next study cohort unless 85 mg/m2 have reached. If 2 of the first
      3 or ≥3 of 6 patients developed DLT at certain dose level, then dose escalation will be
      withheld and the prior dose level will be the maximum tolerated dose (MTD). A minimum of 6
      evaluable patients will be treated at the MTD dose level with no more than 2 of the 6
      patients having DLT at this dose level. The MTD will be considered as the recommended dose
      for future Phase II studies. The number of patient accrual will range from 12 and 18 (6/dose
      level) evaluable patients in the dose-finding stage to determine the MTD of Oxaliplatin in
      this combination regimen.

      Of patients who experience grade 2 sensory neuropathy after the triplet chemotherapy,
      Oxaliplatin will be omitted (only nab-paclitaxel plus S-1/LV will be continued) until the
      recovery of sensory neuropathy to grade 1 or less then Oxaliplatin will be re-instituted.

      CBC/DC, AST/ALT and BUN/Cr will be determined at baseline and every 2 weeks during study
      period. Serum level of albumin, bilirubin (T), LDH, Alk-P/GGT, Na/K/Mg/Ca/P and CRP will be
      determined at baseline and every 4 weeks during the treatment. Radiographic objective tumor
      response assessment, according to RECIST version 1.1, by CT scan or MRI at baseline, and then
      every 6 weeks during the study period. Tumor marker, CEA and CA 19-9, will be evaluated at
      baseline and every 4 weeks during the treatment.
    

Intervention name(s): Oxaliplatin; Albumin-Bound Paclitaxel /nab-Paclitaxel; S-1; LV
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Oxaliplatin 60 - 85 mg/m2 IVD 2hr at D1, every 14 days as a cycle till disease progression; 150 mg/m2 IVD 30 min bi-weekly.; Tegafur,oral S-1 35mg/m2 twice daily from D1 to D7, every 14 days as a cycle till disease progression.; LV 30mg twice daily from D1 to D7, every 14 days as a cycle till disease progression
Other intervention name(s): Oxalip; Abraxane; Tegafur,; Lecovorin
Intervention MeSH terms: Paclitaxel; Albumin-Bound Paclitaxel; Oxaliplatin; Tegafur
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: SOLAR regimen