Phase 1
Completed N=36
A Study of Xeloda (Capecitabine) in Combination With Oxaliplatin in Patients With Metastatic Colorectal Cancer.
Source: ClinicalTrials.gov NCT00353262 ↗Enrolled (actual)
36
Serious AEs
44.4%
Results posted
Jan 2016
Primary outcomePrimary: Area Under The Plasma Concentration-Time Curve From Zero To Infinity (AUC0-Inf) of 5'-Deoxy-5-fluorouridine 5'-(DFUR) — 13605; 12177; 11817 ng/mL*hr
Summary
This single arm study will investigate possible pharmacokinetic interactions between Xeloda and oxaliplatin, and assess whether the pharmacokinetics of Xeloda and/or oxaliplatin is influenced by the addition of Avastin. All subjects will provide samples for pharmacokinetic analysis during the first 3 cycles of treatment. In cycles 1 and 2 patients will receive a treatment regimen containing Xeloda (1000mg/m2 bid) and oxaliplatin (130mg/m2 iv) and in cycle 3 Avastin (7.5mg/kg iv) will be added to the regimen. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under The Plasma Concentration-Time Curve From Zero To Infinity (AUC0-Inf) of 5'-Deoxy-5-fluorouridine 5'-(DFUR) |
13605; 12177; 11817 | — |
| PRIMARY AUC0-inf for Free Platinum |
10069; 10537; 10225 | — |
| SECONDARY AUC (0-infinity) of Capecitabine and Its Metabolites (5'-DFCR, 5-FU, and FBAL) |
5217; 5299; 6130; 7630; 6409; 7989 | — |
| SECONDARY AUC0-last of Capecitabine and Its Metabolites (5'-DFUR, 5'-DFCR, 5 FU, and FBAL) |
13503; 12057; 11618; 5201; 5273; 6093 | — |
| SECONDARY Maximum Plasma Concentration (Cmax) of Capecitabine and Its Metabolites (5'-DFUR, 5'-DFCR, 5 FU, and FBAL) |
8847; 6545; 5693; 4930; 4065; 4167 | — |
| SECONDARY Elimination Half-life Period (t1/2 Beta) of Capecitabine and Its Metabolites (5'-DFUR , 5'-DFCR, 5 FU, and FBAL) |
0.65; 0.64; 0.75; 0.37; 0.51; 0.56 | — |
| SECONDARY AUC0-infinity for Total Platinum |
139329; 167610; 186268 | — |
| SECONDARY AUC0-last of Total And Free Platinum |
85406; 97083; 97011; 9399; 9818; 9604 | — |
| SECONDARY Cmax of Total And Free Platinum |
3652; 3741; 3706; 1818; 1840; 1813 | — |
| SECONDARY T1/2 Beta of Total And Free Platinum |
48.70; 55.73; 67.28; 17.64; 18.41; 18.47 | — |
| SECONDARY Volume of Distribution at Steady State (VSS) of Total And Free Platinum |
109007; 105097; 112141; 387158; 389193; 401040 | — |
| SECONDARY Clearance of Total And Free Platinum |
1603; 1331; 1198; 22183; 21176; 21823 | — |
| SECONDARY Number Of Participants With Adverse Events (AEs) |
36; 16 | — |
| SECONDARY Marked Laboratory Abnormalities |
2; 5; 6; 1; 9; 12 | — |
Eligibility Criteria
Inclusion Criteria
- adult patients, >=18 years of age;
- adenocarcinoma of colon or rectum, with metastatic or locally advanced disease.
Exclusion Criteria
- previous systemic treatment for advanced or metastatic disease;
- previous treatment with oxaliplatin or Avastin.
Data sourced from ClinicalTrials.gov (NCT00353262). 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.