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NCT01164215 · ClinicalTrials.gov registry record · Phase 1

Biomarker-Guided Fluorouracil in Treating Patients With Colorectal Cancer Receiving Combination Chemotherapy

A Phase 1 study, sponsored by UNC Lineberger Comprehensive Cancer Center.

Completed
Registry status
Phase 1
Development phase
76
Enrollment target

NCT01164215: Completed Phase 1 study, sponsored by UNC Lineberger Comprehensive Cancer Center.

NCT01164215 is a Phase 1 study that has completed, run by UNC Lineberger Comprehensive Cancer Center. The registered enrollment target is 76 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (27% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01164215, a Phase 1 study, has completed, sponsored by UNC Lineberger Comprehensive Cancer Center.

COMPLETED
Registry status
Phase 1
Development phase
76 participants
Enrollment target

Study Summary

RATIONALE: Drugs used in chemotherapy, such as fluorouracil, oxaliplatin, and leucovorin calcium, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug, combination chemotherapy, may kill more tumor cells. Studying samples of blood in the laboratory from patients with cancer receiving fluorouracil in combination with oxaliplatin and leucovorin calcium may help doctors learn how fluorouracil works in the body and how patients will respond to treatment. PURPOSE: This phase I trial is studying biomarker-guided fluorouracil in treating patients with colorectal cancer receiving combination chemotherapy.

Interventions

  • DRUG oxaliplatin
  • DRUG fluorouracil
  • DRUG leucovorin

Trial Details

FieldValue
Enrollment Target 76 participants
Start Date 2010-02
Est. Completion 2013-09
Phase Phase 1

What the finished NCT01164215 record still lists

NCT01164215 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 76 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (27% higher).

The record links to 0 conditions, and to 3 interventions - of which oxaliplatin is the first listed.

NCT01164215 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01164215 about?

NCT01164215 is a clinical study titled "Biomarker-Guided Fluorouracil in Treating Patients With Colorectal Cancer Receiving Combination Chemotherapy". RATIONALE: Drugs used in chemotherapy, such as fluorouracil, oxaliplatin, and leucovorin calcium, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug, combination chemotherapy, may kill more tumor cells. S...

What is the current status of trial NCT01164215?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 76 participants. The study started on 2010-02. Estimated completion is 2013-09.

What interventions are being tested in trial NCT01164215?

The interventions under investigation include: oxaliplatin (DRUG), fluorouracil (DRUG), leucovorin (DRUG).

Who is sponsoring clinical trial NCT01164215?

This trial is sponsored by UNC Lineberger Comprehensive Cancer Center, which has 366 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01164215's enrollment target sits among peer trials

76 705th of 2000 higher than 1,290 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01164215, the US trial registry maintained by the National Library of Medicine. NCT01164215 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.