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

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

By condition

Related Studies