Phase 2
Completed N=36
A Study of Capecitabine [Xeloda] in Combination With Trastuzumab [Herceptin] and Oxaliplatine in Patients With Resectable Gastric Cancer
Source: ClinicalTrials.gov NCT01130337 ↗Enrolled (actual)
36
Serious AEs
61.1%
Results posted
Oct 2015
Primary outcomePrimary: Percentage of Participants With Disease-free Survival (DFS) at Month 18 — 76.12 percentage of participants
Summary
This study will evaluate the disease free survival rate of a combination of capecitabine [Xeloda] and oxaliplatin (XELOX) with trastuzumab [Herceptin] in patients with resectable gastric cancer. The combination of Xeloda (orally, 1000 mg/m2 on day 1-14 of every cycle) and Herceptin (intravenously, 8 mg/kg loading dose, then 6 mg/kg on days 1-14 of every cycle) will be administered for three cycles prior to surgery to resect the tumor. If complete resection, R0 or microscopic residual tumor R1 is achieved, patients will continue with three cycles of XELOX and Herceptin and then for completion of 12 months treatment with Herceptin alone. Oxaliplatin will be administered intravenously at a dose of 130 mg/m2 on day 1 in every cycle. The anticipated time on study drug will be 12 months.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Disease-free Survival (DFS) at Month 18 |
76.12 | — |
| SECONDARY Percentage of Participants With Pathological Complete Response (pCR) |
8.33 | — |
| SECONDARY Percentage of Participants With Complete Tumor Resection (R0) |
90.32 | — |
| SECONDARY Percentage of Participants With Objective Response |
38.89 | — |
Eligibility Criteria
Inclusion Criteria
- Adult patients over 18 years of age
- Locally advanced resectable HER2-positive gastric or esophagogastric junction adenocarcinoma (Sievert types I, II, III)
- Measurable (RECIST criteria) or assessable disease
- ECOG performance 0-2
- Life expectancy of 12 weeks or more
Exclusion Criteria
- Immeasurable lesion as the only evidence of disease
- Previous chemotherapy or radiotherapy for gastric neoplasm or some kind of previous surgical resection of the tumor (except diagnostic laparoscopy)
- Concomitant heart disease
Data sourced from ClinicalTrials.gov (NCT01130337). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.