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COMPLETED Phase 3

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

NCT00101686 · View on ClinicalTrials.gov ↗

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

769 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00101686

The ClinicalTrials.gov registry entry for NCT00101686 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 547 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 769 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00101686 reports 20 study locations spanning 5 distinct geographic areas — top geographies include California, Alabama, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00101686?

This trial is sponsored by Pfizer, which has 769 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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