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NCT00101686 · ClinicalTrials.gov registry record · Phase 3

Trial Of Irinotecan In Combination With Three Methods Of Administration Of Fluoropyrimidine.

A Phase 3 study of Colorectal Neoplasms, sponsored by Pfizer.

Completed
Registry status
Phase 3
Development phase
547
Enrollment target
20
Study locations

NCT00101686 is a Phase 3 study of Colorectal Neoplasms that has completed, run by Pfizer. The registered enrollment target is 547 participants, roughly in line with the 566-participant average among 54 other Colorectal Neoplasms trials with a reported enrollment target. The trial reports 20 study locations across 5 states.

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The verdict

NCT00101686, a Phase 3 study of Colorectal Neoplasms, has completed, sponsored by Pfizer.

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

Study Summary

This study compares in the first study period combination of Irinotecan with three different methods of administration by Fluoropyrimidine. (ie. infusion, bolus and oral). In the second period of study it compares FOLFIRI \[a chemotherapy regime that combines bolus irinotecan and leucovorin \[LV\] with infusional 5-fluorouracil (5-FU)\] + bevacizumab and mlFL + bevacizumab. Measures of efficacy and safety will be reported.

Conditions Studied

Interventions

  • DRUG Modified Bolus 5-FU/LV with Irinotecan
  • DRUG FOLFIRI + bevacizumab
  • DRUG miFL + bevacizumab
  • DRUG Infusional 5-FU/LV with Irinotecan
  • DRUG Oral Capecitabine with Irinotecan

Study Locations (20)

California

  • Pfizer Investigational Site - Arroyo Grande
  • Pfizer Investigational Site - Fountian Valley
  • Pfizer Investigational Site - Fresno
  • Pfizer Investigational Site - Los Gatos
  • Pfizer Investigational Site - Mission Hills
  • Pfizer Investigational Site - Modesto
  • Pfizer Investigational Site - Orange
  • Pfizer Investigational Site - Oxnard
  • Pfizer Investigational Site - San Diego
  • Pfizer Investigational Site - San Jose

Alabama

  • Pfizer Investigational Site - Birmgingham
  • Pfizer Investigational Site - Birmingham
  • Pfizer Investigational Site - Birmngham
  • Pfizer Investigational Site - Mobile

Arizona

  • Pfizer Investigational Site - Flagstaff
  • Pfizer Investigational Site - Sedona
  • Pfizer Investigational Site - Tucson

Arkansas

  • Pfizer Investigational Site - Hot Spring
  • Pfizer Investigational Site - Springdale

Colorado

  • Pfizer Investigational Site - Boulder

Trial Details

FieldValue
Enrollment Target 547 participants
Start Date 2003-02
Est. Completion 2008-10
Phase Phase 3

Sponsor

Pfizer

1,845 total trials

What the Registry Record Tells You About NCT00101686

The ClinicalTrials.gov registry entry for NCT00101686 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 547 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 566-participant average among 54 other Colorectal Neoplasms trials with a reported enrollment target. The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Colorectal Neoplasms appearing as the primary indexed condition, and to 5 interventions - of which Modified Bolus 5-FU/LV with Irinotecan is the first listed.

NCT00101686 reports 20 study locations spanning 5 distinct geographic areas - top geographies include California, Alabama, Arizona.

Frequently Asked Questions

What is clinical trial NCT00101686 about?

NCT00101686 is a clinical study titled "Trial Of Irinotecan In Combination With Three Methods Of Administration Of Fluoropyrimidine.". This study compares in the first study period combination of Irinotecan with three different methods of administration by Fluoropyrimidine. (ie. infusion, bolus and oral). In the second period of study it compares FOLFIRI \[a chemotherapy regime that combines bolus irinotecan and leucovorin \[LV\] w...

What is the current status of trial NCT00101686?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 547 participants. The study started on 2003-02. Estimated completion is 2008-10.

What conditions does trial NCT00101686 study?

This clinical trial studies the following conditions: Colorectal Neoplasms.

What interventions are being tested in trial NCT00101686?

The interventions under investigation include: Modified Bolus 5-FU/LV with Irinotecan (DRUG), FOLFIRI + bevacizumab (DRUG), miFL + bevacizumab (DRUG), Infusional 5-FU/LV with Irinotecan (DRUG), Oral Capecitabine with Irinotecan (DRUG).

Who is sponsoring clinical trial NCT00101686?

This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00101686 being conducted?

This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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