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NCT00069108 · ClinicalTrials.gov registry record · Phase 3

A Study of Xeloda (Capecitabine) in Patients With Metastatic Colorectal Cancer

A Phase 3 study of Colorectal Cancer, sponsored by Hoffmann-La Roche.

Completed
Registry status
Phase 3
Development phase
627
Enrollment target
20
Study locations

NCT00069108 is a Phase 3 study of Colorectal Cancer that has completed, run by Hoffmann-La Roche. The registered enrollment target is 627 participants, below the 1,510-participant average among 369 other Colorectal Cancer trials with a reported enrollment target (58% lower). The trial reports 20 study locations across 13 states.

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The verdict

NCT00069108, a Phase 3 study of Colorectal Cancer, has completed, sponsored by Hoffmann-La Roche.

COMPLETED
Registry status
Phase 3
Development phase
627 participants
Enrollment target
20
Study locations

Study Summary

This 2 arm study will assess the efficacy and safety of intermittent oral Xeloda, or iv fluorouracil/leucovorin, in combination with intravenous Eloxatin (oxaliplatin) in patients previously treated for metastatic colorectal cancer. Patients will be randomized to receive either 1)XELOX (Xeloda 1000mg/m2 po bid on days 1-15 + oxaliplatin) in 3 week cycles or 2) FOLFOX-4 (oxaliplatin + leucovorin + 5-FU in 2 week cycles. The anticipated time on study treatment is until disease progression, and the target sample size is 500+ individuals.

Conditions Studied

Colorectal Cancer

Interventions

  • DRUG Leucovorin
  • DRUG Oxaliplatin
  • DRUG capecitabine [Xeloda]
  • DRUG 5 FU

Study Locations (20)

Other

  • - Brussels
  • - Brussels
  • - Ghent
  • - Kortrijk
  • - Mont-godinne

Ontario

  • - London
  • - Oshawa
  • - Ottawa
  • - Saint Catherines

California

  • - Bakersfield

Colorado

  • - Colorado Springs

District of Columbia

  • - Washington D.C.

Indiana

  • - Terre Haute

Missouri

  • - St Louis

Montana

  • - Billings

Trial Details

FieldValue
Enrollment Target 627 participants
Start Date 2003-07
Est. Completion 2006-08
Phase Phase 3

Sponsor

Hoffmann-La Roche

909 total trials

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What the Registry Record Tells You About NCT00069108

The ClinicalTrials.gov registry entry for NCT00069108 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 627 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,510-participant average among 369 other Colorectal Cancer trials with a reported enrollment target (58% lower). The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Colorectal Cancer appearing as the primary indexed condition, and to 4 interventions - of which Leucovorin is the first listed.

NCT00069108 reports 20 study locations spanning 13 distinct geographic areas - top geographies include Other, Ontario, California.

Frequently Asked Questions

What is clinical trial NCT00069108 about?

NCT00069108 is a clinical study titled "A Study of Xeloda (Capecitabine) in Patients With Metastatic Colorectal Cancer". This 2 arm study will assess the efficacy and safety of intermittent oral Xeloda, or iv fluorouracil/leucovorin, in combination with intravenous Eloxatin (oxaliplatin) in patients previously treated for metastatic colorectal cancer. Patients will be randomized to receive either 1)XELOX (Xeloda 1000m...

What is the current status of trial NCT00069108?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 627 participants. The study started on 2003-07. Estimated completion is 2006-08.

What conditions does trial NCT00069108 study?

This clinical trial studies the following conditions: Colorectal Cancer.

What interventions are being tested in trial NCT00069108?

The interventions under investigation include: Leucovorin (DRUG), Oxaliplatin (DRUG), capecitabine [Xeloda] (DRUG), 5 FU (DRUG).

Who is sponsoring clinical trial NCT00069108?

This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00069108 being conducted?

This trial has 20 study locations across California, Colorado, District of Columbia, Indiana, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.