An Open-label Study to Assess the Pharmacokinetic Interaction Between Xeloda and Oxaliplatin in Patients With Metastatic Colorectal Cancer.
Phase 1
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer
Both
Colorectal Cancer
Trial Information
An Open-label Study to Assess the Pharmacokinetic Interaction Between Xeloda and Oxaliplatin in Patients With Metastatic Colorectal Cancer.
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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
AUCo-inf of 5 DFUR, and free platinum.
Outcome Time Frame:
Cycles 1, 2 and 3 of treatment
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
United States: Food and Drug Administration
Study ID:
NP18587
NCT ID:
NCT00353262
Start Date:
July 2005
Completion Date:
August 2008
Related Keywords:
- Colorectal Cancer
- Colorectal Neoplasms
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