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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00353262
First received: July 17, 2006
Last updated: November 24, 2014
Last verified: November 2014
  Purpose

This single arm study will investigate possible pharmacokinetic interactions bet ween Xeloda and oxaliplatin, and assess whether the pharmacokinetics of Xeloda a nd/or oxaliplatin is influenced by the addition of Avastin. All subjects will pr ovide samples for pharmacokinetic analysis during the first 3 cycles of treatmen t. 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 3-1 2 months, and the target sample size is <100 individuals.


Condition Intervention Phase
Colorectal Cancer
Drug: Avastin
Drug: Oxaliplatin
Drug: capecitabine [Xeloda]
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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:


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 Start Date: July 2005
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Avastin
7.5mg/kg iv (cycle 3 only)
Drug: Oxaliplatin
130mg/m2 iv (cycles 1, 2 and 3)
Drug: capecitabine [Xeloda]
1000mg/m2 po bid (cycles 1, 2 and 3)

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Canada, Ontario
Hamilton, Ontario, Canada, L8V 5C2
Ottawa, Ontario, Canada, K1H 8L6
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00353262     History of Changes
Other Study ID Numbers: NP18587
Study First Received: July 17, 2006
Last Updated: November 24, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases
Capecitabine
Oxaliplatin
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014