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

Part of paid clinical trials in Hoover, Alabama.

Sponsor
Hoffmann-La Roche
Study ID
NCT00048126
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Irinotecan — DRUG
    100mg/m2 iv on days 1, 8, 15 and 22 of each 6 week cycle.
  • capecitabine [Xeloda] — DRUG
    1000mg po bid

Study Details

This study will assess the efficacy and safety of continuous oral Xeloda administration in combination with intravenous 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
Jul 31, 2001
Status verified
Nov 2016
Primary completion
Jan 31, 2005
Completion
Jan 31, 2005

Study Design

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

Arms

  • Experimental: 1

Primary Outcome Measure

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

Locations (10)

FacilityCityStateZIPSite coordinators
-HooverAlabama35216-
-La JollaCalifornia92037-1030-
-MiamiFlorida33176-
-BostonMassachusetts02120-
-AlbuquerqueNew Mexico87102-
-New YorkNew York10028-
-CharlotteNorth Carolina28233-3549-
-ProvidenceRhode Island02908-
-MemphisTennessee38120-
-NashvilleTennessee37203-1632-

Find similar trials in Hoover, AL

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By condition
Colorectal cancer
By specialty
OncologyGI oncology

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