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

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

By condition
Colorectal cancer
By specialty
OncologyGI oncology

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