Phase 3
Completed N=627
A Study of Xeloda (Capecitabine) in Patients With Metastatic Colorectal Cancer
Source: ClinicalTrials.gov NCT00069108 ↗Enrolled (actual)
627
Serious AEs
30.9%
Results posted
Feb 2016
Primary outcomePrimary: Progression Free Survival — 154; 168 days — p=0.00584
Summary
This 2 arm study will assess the efficacy and safety of intermittent oral Xeloda, or iv fluorouracil/leucovorin, in combination with intravenous Eloxatin (oxaliplatin) in patients previously treated for metastatic colorectal cancer. Patients will be randomized to receive either 1)XELOX (Xeloda 1000mg/m2 po bid on days 1-15 + oxaliplatin) in 3 week cycles or 2) FOLFOX-4 (oxaliplatin + leucovorin + 5-FU in 2 week cycles. The anticipated time on study treatment is until disease progression, and the target sample size is 500+ individuals.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival |
154; 168 | 0.00584 sig |
| SECONDARY Progression Free Survival Based on Independent Review Committee Assessment |
168; 162 | 0.00223 sig |
| SECONDARY Progression Free Survival Based on Treatment Analysis- Intent To Treat Population |
145; 152 | — |
| SECONDARY Progression Free Survival Based on Treatment Analysis- Per Population |
153; 164 | — |
| SECONDARY Best Overall Response, Investigators' Assessments |
63; 55; 0; 2; 63; 53 | 0.4028 |
| SECONDARY Best Overall Response, Independent Review Committee Assessment |
48; 39; 0; 0; 48; 39 | 0.2911 |
| SECONDARY Overall Survival |
363; 382 | — |
| SECONDARY Time To Response |
13; 11; 26; 23; 22; 18 | — |
| SECONDARY Duration Of Response |
169; 190 | — |
| SECONDARY Time To Treatment Failure |
125; 121.5 | — |
| SECONDARY Number of Participants With Marked Post-baseline Laboratory Abnormalities by Trial Treatment |
90; 110; 193; 174; 184; 201 | — |
Eligibility Criteria
Inclusion Criteria
- adult patients >=18 years of age;
- metastatic colorectal cancer;
- >=1 target lesion;
- failed first-line chemotherapy with 5-fluorouracil and irinotecan.
Exclusion Criteria
- previous treatment with oxaliplatin;
- progressive or recurrent disease during or within 6 months of completion of first-line chemotherapy;
- >=1 previous chemotherapeutic agent or systemic anticancer regimen for metastatic disease.
Data sourced from ClinicalTrials.gov (NCT00069108). 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.