A Study of Xeloda (Capecitabine) in Patients With Advanced and/or Metastatic Colorectal Cancer

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Hoffmann-La Roche
Study ID
NCT00048139
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Irinotecan — DRUG
    250mg/m2 iv on day 1 of each 3 week cycle
  • capecitabine [Xeloda] — DRUG
    1000mg/m2 po bid on days 1-15 of each 3 week cycle

Study Details

This study will assess the efficacy and safety of intermittent oral Xeloda administration in combination with irinotecan as a first-line treatment in patients with advanced and/or metastatic colorectal cancer. The anticipated time on study treatment is 3-12 months and the target sample size is \<100 individuals.

Key Dates

First listed
Oct 25, 2002
Start date
Oct 31, 2001
Status verified
Nov 2016
Primary completion
Jun 30, 2005
Completion
Jun 30, 2005

Study Design

Enrollment
52 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 1

Primary Outcome Measure

Tumor measurement (RECIST criteria) [ Time Frame: Event driven ]

Locations (11)

FacilityCityStateZIPSite coordinators
-PhoenixArizona85012-
-Fountain ValleyCalifornia92708-
-La JollaCalifornia92037-1030-
-Santa RosaCalifornia95403-
-DenverColorado80262-
-HutchinsonKansas67502-
-Las VegasNevada89109-
-AlbuquerqueNew Mexico87102-
-AlbuquerqueNew Mexico87131-5636-
-BuffaloNew York14263-
-HoustonTexas77030-

Find similar trials in Phoenix, AZ

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By condition
Colorectal cancer
By specialty
OncologyGI oncology

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