Table 3. Selected ongoing clinical trials in small bowel adenocarcinoma. Ref: www.clinicaltrials.gov.
Clinicaltrials.gov | Title | Treatment | Phase | Primary outcome measure | Sponsor/Collaborators | Anticipated completion date |
---|---|---|---|---|---|---|
NCT01202409 | Phase II Study of Panitumumab Combined With Capecitabine and Oxaliplatin (CAPOX) in Patients With KRAS Wild-type Locally Advanced or Metastatic Adenocarcinoma of the Small Bowel or Ampulla of Vater | Capecitabine 750 mg/m2 bid × 14 days, Oxaliplatin 130 mg/m2 day 1 and Panitumumab 9 mg/kg day 1 every 21 day cycle | II | Response Rate | M.D. Anderson Cancer Center/Amgen | Nov-14 |
NCT00433550 | A Phase II Trial of Pharmacogenetic-Based Dosing of Irinotecan (I), Oxaliplatin (O), and Capecitabine (C) as First-Line Therapy for Advanced Small Bowel Adenocarcinoma | Group 1 (6/6 UGT1A1 genotype): I (d1)+O (d1)+C (d2-15). Group 2 (6/7): I as group 1, Lower doses of O and C. Group 3 (7/7): I, O and C at lower doses |
II | Tumor response after 12 courses of study treatment | North Central Cancer Treatment Group/National Cancer Institute (NCI) | Dec-12 |
NCT01208103 | Phase II Study of Bevacizumab Combined With Capecitabine and Oxaliplatin (CAPOX) in Patients With Advanced Adenocarcinoma of the Small Bowel or Ampulla of Vater | Capecitabine 750 mg/m2 bid × 14 days, Oxaliplatin 130 mg/m2 day 1 and Bevacizumab 7.5 mg/kg day 1 every 21 day cycle | II | Progression free survival | M.D. Anderson Cancer Center/Genentech | May-15 |
NCT00987766 | Phase Ib Trial of Gemcitabine and Oxaliplatin (GEMOX) With Erlotinib in Patients With Advanced Biliary Tract Cancer. (includes Pancreatic Cancer, Duodenal Cancer, or Ampullary Cancer) | Erlotinib by mouth daily 6 days every other week, Gemcitabine IV every other week, Oxaliplatin IV every other week | I | MTD and recommended phase II dose of erlotinib in combination with gemcitabine and oxaliplatin | Vanderbilt-Ingram Cancer Center/National Cancer Institute (NCI) | Jan-16 |