Phase 2
N=158
A Study of Xeloda (Capecitabine) in Combination With Chemotherapy in Patients With Advanced and/or Metastatic Gastric Cancer.
Gastric Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00454636 ↗Enrolled (actual)
158
Serious AEs
35.4%
Results posted
Aug 2016
Primary outcome: Primary: Percentage of Participants With Grade 3 Hand-Foot Syndrome (HFS) — 2.4; 6.3; 3.7; 5.2 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Cisplatin (Drug); Capecitabine (Drug); Epirubicin (Drug); Oxaliplatin (Drug); Docetaxel (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Grade 3 Hand-Foot Syndrome (HFS) |
2.4; 6.3; 3.7; 5.2 | — |
| SECONDARY Overall Response Rate (ORR) |
43.3; 40.7; 69.6; 59.6 | — |
| SECONDARY Progression-Free Survival (PFS) |
4.43; 5.17; 7.07; 7.87 | — |
| SECONDARY Overall Survival (OS) |
10.23; 8.87; 13.87; 12.43 | — |
| SECONDARY Duration of Response |
308.92; 154.09; 203.06; 205.52 | — |
| SECONDARY Time to Response |
132.92; 126.64; 123.50; 138.16 | — |
Summary
This study will assess the safety and efficacy of Xeloda, given in combination with standard chemotherapy regimens, for the first-line treatment of advanced and/or metastatic gastric cancer. All patients will receive Xeloda in combination with one of 4 standard chemotherapy regimens; the dose of Xeloda will be from 625mg/m2 - 1000mg/m2 bid orally, depending on the chemotherapy regimen used. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.
Eligibility Criteria
Inclusion Criteria
- adult patients, >=18 years of age;
- advanced or metastatic gastric cancer;
- Eastern Cooperative Oncology Group (ECOG) =6 months prior to study);
- evidence of central nervous system (CNS) metastasis;
- history of another malignancy within the last 5 years (except for successfully treated basal cell cancer of skin, or in situ cancer of the cervix);
- clinically significant cardiac disease.
Data sourced from ClinicalTrials.gov (NCT00454636). 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.