A Study of Xeloda (Capecitabine) in Combination With Oxaliplatin in Patients With Metastatic Colorectal Cancer. - Full Text View

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00353262

Purpose

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.

Condition	Intervention	Phase
Colorectal Cancer	Drug: capecitabine [Xeloda] Drug: Oxaliplatin Drug: Avastin	Phase I

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics Study
Official Title:	An Open-Label Study to Assess the Pharmacokinetic Interaction Between Xeloda and Oxaliplatin in Patients With Metastatic Colorectal Cancer.

Resource links provided by NLM:

MedlinePlus related topics: Cancer Colorectal Cancer

Drug Information available for: Oxaliplatin Capecitabine

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

AUCo-inf of 5 DFUR, and free platinum. [ Time Frame: Cycles 1, 2 and 3 of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Pharmacokinetic parameters of capecitabine and its metabolites, and free platinum [ Time Frame: Cycles 1, 2 and 3 of treatment ] [ Designated as safety issue: No ]
AEs, laboratory parameters [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment:	36
Study Completion Date:	August 2008

Arms	Assigned Interventions
1: Experimental	Drug: capecitabine [Xeloda] 1000mg/m2 po bid (cycles 1, 2 and 3) Drug: Oxaliplatin 130mg/m2 iv (cycles 1, 2 and 3) Drug: Avastin 7.5mg/kg iv (cycle 3 only)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00353262

Locations

Canada, Ontario

TORONTO, Ontario, Canada, M5G 2M9

HAMILTON, Ontario, Canada, L8V 5C2

OTTAWA, Ontario, Canada, K1H 1C4

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

No publications provided

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	NP18587
Study First Received:	July 17, 2006
Last Updated:	May 13, 2009
ClinicalTrials.gov Identifier:	NCT00353262 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Antimetabolites
Capecitabine
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Bevacizumab
Intestinal Diseases

Rectal Diseases
Intestinal Neoplasms
Oxaliplatin
Digestive System Diseases
Gastrointestinal Neoplasms
Colorectal Neoplasms

Additional relevant MeSH terms:

Antimetabolites
Capecitabine
Antimetabolites, Antineoplastic
Digestive System Neoplasms
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

Pharmacologic Actions
Intestinal Neoplasms
Neoplasms
Oxaliplatin
Neoplasms by Site
Digestive System Diseases
Therapeutic Uses
Gastrointestinal Neoplasms
Colorectal Neoplasms

ClinicalTrials.gov processed this record on September 03, 2009