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NCT00103259 · ClinicalTrials.gov registry record · Phase 2

Bortezomib With or Without Irinotecan in Treating Patients With Locally Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

A Phase 2 study, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 2
Development phase
71
Enrollment target

NCT00103259: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).

NCT00103259 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 71 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00103259, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 2
Development phase
71 participants
Enrollment target

Study Summary

This randomized phase II trial is studying bortezomib and irinotecan to see how well they work compared to bortezomib alone in treating patients with locally recurrent or metastatic squamous cell carcinoma of the head and neck. Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bortezomib together with irinotecan may kill more tumor cells. It is not yet known whether giving bortezomib together with irinotecan is more effective than bortezomib alone in treating head and neck cancer.

Interventions

  • OTHER laboratory biomarker analysis
  • DRUG bortezomib
  • DRUG irinotecan hydrochloride

Trial Details

FieldValue
Enrollment Target 71 participants
Start Date 2005-07
Est. Completion 2011-11
Phase Phase 2

Sponsor

National Cancer Institute (NCI)

3,257 total trials

What the Registry Record Tells You About NCT00103259

The ClinicalTrials.gov registry entry for NCT00103259 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 71 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

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

NCT00103259 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00103259 about?

NCT00103259 is a clinical study titled "Bortezomib With or Without Irinotecan in Treating Patients With Locally Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck". This randomized phase II trial is studying bortezomib and irinotecan to see how well they work compared to bortezomib alone in treating patients with locally recurrent or metastatic squamous cell carcinoma of the head and neck. Bortezomib may stop the growth of tumor cells by blocking some of the en...

What is the current status of trial NCT00103259?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 71 participants. The study started on 2005-07. Estimated completion is 2011-11.

What interventions are being tested in trial NCT00103259?

The interventions under investigation include: laboratory biomarker analysis (OTHER), bortezomib (DRUG), irinotecan hydrochloride (DRUG).

Who is sponsoring clinical trial NCT00103259?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

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, the data changelog, or report a data error.