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NCT01183494 · ClinicalTrials.gov registry record · Phase 1

A Genotype-guided Study of Irinotecan Administered in Combination With 5-fluorouracil/Leucovorin (FOLFIRI) and Bevacizumab in Advanced Colorectal Cancer Patients

A Phase 1 study of Metastatic Colorectal Cancer, sponsored by University of Chicago.

Completed
Registry status
Phase 1
Development phase
17
Enrollment target
2
Study locations

NCT01183494 is a Phase 1 study of Metastatic Colorectal Cancer that has completed, run by University of Chicago. The registered enrollment target is 17 participants, below the 186-participant average among 45 other Metastatic Colorectal Cancer trials with a reported enrollment target (91% lower). The trial reports 2 study locations across 2 states.

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The verdict

NCT01183494, a Phase 1 study of Metastatic Colorectal Cancer, has completed, sponsored by University of Chicago.

COMPLETED
Registry status
Phase 1
Development phase
17 participants
Enrollment target
2
Study locations

Study Summary

This study is being done to determine the maximum dose of a certain chemotherapy drug (irinotecan) that can be tolerated as part of a combination of drugs. There is a combination of chemotherapy drugs typically used to treat cancer of the colon and rectum: 5-Flurouracil (5-FU), leucovorin, and irinotecan; the combination is known as FOLFIRI. At the present time, the Food and Drug Administration (FDA) has approved this drug combination for the treatment of cancers of the colon and rectum. The FDA has also approved the use of a drug called bevacizumab (or Avastin) in combination with FOLFIRI, and this is considered one of the standards of care for all patients with colon and rectal cancer which has spread. The best dose of irinotecan to use in the combination of FOLFIRI and bevacizumab is not known. Earlier studies have shown that higher doses of irinotecan can be used safely as part of the FOLFIRI combination, but it is unclear whether these same doses will be safe when bevacizumab is added to this combination.

Conditions Studied

Metastatic Colorectal Cancer

Interventions

  • DRUG FOLFIRI, Avastin, Irinotecan

Study Locations (2)

Illinois

  • The University of Chicago - Chicago

Other

  • CRO-National Cancer Institute - Aviano

Trial Details

FieldValue
Enrollment Target 17 participants
Start Date 2009-12-12
Est. Completion 2017-06-02
Phase Phase 1

Sponsor

University of Chicago

796 total trials

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What the Registry Record Tells You About NCT01183494

The ClinicalTrials.gov registry entry for NCT01183494 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 186-participant average among 45 other Metastatic Colorectal Cancer trials with a reported enrollment target (91% lower). The listed sponsor is University of Chicago, which has 796 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Metastatic Colorectal Cancer appearing as the primary indexed condition, and to 1 intervention - of which FOLFIRI, Avastin, Irinotecan is the first listed.

NCT01183494 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Illinois, Other.

Frequently Asked Questions

What is clinical trial NCT01183494 about?

NCT01183494 is a clinical study titled "A Genotype-guided Study of Irinotecan Administered in Combination With 5-fluorouracil/Leucovorin (FOLFIRI) and Bevacizumab in Advanced Colorectal Cancer Patients". This study is being done to determine the maximum dose of a certain chemotherapy drug (irinotecan) that can be tolerated as part of a combination of drugs. There is a combination of chemotherapy drugs typically used to treat cancer of the colon and rectum: 5-Flurouracil (5-FU), leucovorin, and irino...

What is the current status of trial NCT01183494?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2009-12-12. Estimated completion is 2017-06-02.

What conditions does trial NCT01183494 study?

This clinical trial studies the following conditions: Metastatic Colorectal Cancer.

What interventions are being tested in trial NCT01183494?

The interventions under investigation include: FOLFIRI, Avastin, Irinotecan (DRUG).

Who is sponsoring clinical trial NCT01183494?

This trial is sponsored by University of Chicago, which has 796 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01183494 being conducted?

This trial has 2 study locations across Illinois. 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

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.