Table 4.
Selected current phase II and III studies evaluating trastuzumab in gastroesophageal cancer.
| Study, Sponsor, (ClinicalTrials. gov ID) | Phase | n | Population | Treatment | Primary endpoint |
|---|---|---|---|---|---|
| Operable disease | |||||
| RTOG-1010 NCI/RTOG, (NCT01196390) |
III | 480 | Operable adenocarcinoma of the middle or lower oesophagus or OGJ | Weekly carboplatin, paclitaxel ± trastuzumab + radical radiotherapy. Adjuvant trastuzumab × 39 weeks (all patients). | DFS |
| AIO-STO-0310 AIO-Studien-gGmbH (NCT01472029) |
II | 53 | Locally advanced resectable adenocarcinoma of the OGJ or stomach | Perioperative 5-FU, leucovorin, docetaxel, and oxaliplatin + trastuzumab | pCR rate |
| ML25189 Hoffmann-La Roche, (NCT01130337) |
II | 45 | Resectable gastric adenocarcinoma | 3 × CAPOX + trastuzumab before and after surgery, 12 months adjuvant trastuzumab | DFS |
| Advanced disease: first line | |||||
| Hoffman-La Roche (NCT01450696) | III | 400 | HER-2-positive metastatic adenocarcinoma of OGJ and stomach | Cisplatin + capecitabine + trastuzumab 8mg loading dose then 6 mg versus 10 mg/kg q 21 days | OS |
| AMC-ONCGI-1101 Asan Medical Centre (NCT01396707) |
II | 56 | HER-2-positive locally advanced or metastatic adenocarcinoma of OGJ and stomach | CAPOX + trastuzumab | ORR |
| M10B-DOCT The Netherlands Cancer Institute (NCT01359397) |
II | Not stated | HER-2-positive locally advanced or metastatic adenocarcinoma of OGJ and stomach | Docetaxel, oxaliplatin, capecitabine + bevacizumab ± trastuzumab | PFS |
| 09-457 Dana-Farber Cancer Institute (NCT01191697) |
II | 36 | HER-2-positive locally advanced or metastatic adenocarcinoma of OGJ and stomach | CAPOX + bevacizumab + trastuzumab | ORR |
| BP27836 Hoffmann-La Roche (NCT01461057) |
II | 30 | HER-2-positive locally advanced or metastatic adenocarcinoma of OGJ and stomach | Cisplatin + capecitabine + trastuzumab + pertuzumab | Safety |
| National University Hospital, Singapore (NCT01228045) | II | 30 | Advanced HER-2 positive gastric cancer | S-1 + cisplatin + trastuzumab | Not stated |
| Advanced disease: second line | |||||
| CAUY922A2205 Novartis (NCT01402401) |
II | 48 | HER-2-positive advanced gastric or OGJ cancer, previously treated with chemotherapy + trastuzumab | Trastuzumab + AUY922 (HSP90 inhibitor) | ORR |
DFS, disease-free survival; PFS, progression-free survival; pCR, pathological complete remission; OS, overall survival; HR, hazard ratio; OR, odds ratio; CI, confidence interval; OGJ, oesophagogastric junction; ORR, overall response rate; CAPOX, capecitabine + oxaliplatin; ECF, epirubicin, cisplatin + infused 5-fluorouracil; ECX, epirubicin, cisplatin + capecitabine.