Phase 2
Completed N=21
Capecitabine and Cisplatin (XP)+Sorafenib in Advanced Gastric Cancer (AGC): Sorafenib+XP
Source: ClinicalTrials.gov NCT00565370 ↗Enrolled (actual)
21
Serious AEs
19.1%
Results posted
Aug 2015
Primary outcomePrimary: Number of Participants Who Experienced Dose Limiting Toxicities (DLTs) — 3 participants
Summary
There is strong scientific rationale for exploring the role of sorafenib with capecitabine and cisplatin (XP) in AGC. XP is a new standard of care in AGC and sorafenib is a novel signal transduction inhibitor that prevents tumor cell proliferation and angiogenesis through blockade of the Raf/MEK/ERK pathway at the level of Raf kinase and the receptor tyrosine kinases VEGF-R2 and PDGFR-beta.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Experienced Dose Limiting Toxicities (DLTs) |
3 | — |
| PRIMARY Progression-free Survival |
10.0 | — |
| SECONDARY Response Rate |
62.8 | — |
| SECONDARY Overall Survival |
14.7 | — |
| SECONDARY Toxicity Profile (According to National Cancer Institute Common Terminology Criteria for Adverse Event Version 3.0) |
21 | — |
Eligibility Criteria
Inclusion Criteria
- Having given signed written informed consent
- Unresectable advanced gastric adenocarcinoma, initially diagnosed or recurred
- No history of chemotherapy or radiation
- Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST)
- Age 18-75 years
- Estimated life expectancy of more than 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Adequate bone marrow function (absolute neutrophil count > 1,500/µL, platelets > 100,000/µL, hemoglobin > 8g/dl),
- Adequate kidney function (creatinine clearance > 60 ml/min)
- Adequate liver function (bilirubin Grade I)
- History of significant neurologic or psychiatric disorders
- Pregnant or lactating women, women of childbearing potential not employing adequate contraception
- Other serious illness or medical conditions
- Known allergy to study drugs
Data sourced from ClinicalTrials.gov (NCT00565370). 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.