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Study of Capecitabine With Irinotecan and Oxaliplatin (Eloxatin) in Advanced Colorectal Cancer

NCT00215982 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2013-11-25

No results posted yet for this study

Summary

The purpose of this study is to find out how effective the new combination of the drugs Capecitabine (Xeloda), Oxaliplatin (Eloxatin), and Irinotecan (Camptosar) are against colon and rectal cancer. All three of these drugs are approved by the Food and Drug Administration (FDA) for the treatment of colon or rectal cancer. This however is the first time that these three drugs have been combined in this schedule for the treatment of colon/rectal cancer.

Conditions

Interventions

DRUG

capecitabine

Capecitabine will be administered at a dose of 825 mg/m2 PO BID, for a total daily dose of 1650 mg/m2. Capecitabine will be administered on days 1-14 followed by 7 day treatment free rest period and days 21-35 followed by a 7 day treatment-free rest period, every six weeks (42 days) of treatment is considered one cycle.

DRUG

Oxaliplatin

Oxaliplatin will be administered at a dose of 130 mg/m2 IV over 120 minutes in 250-500 ML D5W on day 1, every 42 days.

DRUG

Irinotecan

Irinotecan will be administered at a dose of 180mg/m2 IV over 90 minutes on day 21 every 42 days.

Sponsors & Collaborators

  • Roche Pharma AG

    collaborator INDUSTRY

  • H. Lee Moffitt Cancer Center and Research Institute

    lead OTHER

Principal Investigators

  • Christopher Garrett, MD · H. Lee Moffitt Cancer Center & Research Institute (now at M.D. Anderson)

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-12-31
Primary Completion
2007-07-31
Completion
2007-07-31

Countries

  • United States
  • Puerto Rico

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00215982 on ClinicalTrials.gov