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NCT00629226 · ClinicalTrials.gov registry record · Phase 1

Bortezomib, Cetuximab, and Radiation Therapy With or Without Cisplatin in Treating Patients With Stage IV Head and Neck Cancer

A Phase 1 study, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 1
Development phase
46
Enrollment target

NCT00629226: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).

NCT00629226 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 46 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (23% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00629226, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 1
Development phase
46 participants
Enrollment target

Study Summary

RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Radiation therapy uses high energy x- rays to kill tumor cells. Bortezomib and cetuximab may make tumor cells more sensitive to radiation therapy. Drugs used in chemotherapy, such as cisplatin, 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 cetuximab, radiation therapy, and cisplatin may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of bortezomib when given together with cetuximab and radiation therapy with or without cisplatin in treating patients with stage IV head and neck cancer.

Interventions

  • DRUG cisplatin
  • RADIATION intensity-modulated radiation therapy
  • BIOLOGICAL cetuximab
  • DRUG bortezomib

Trial Details

FieldValue
Enrollment Target 46 participants
Start Date 2007-10
Phase Phase 1
National Cancer Institute (NCI)

3,257 total trials

What the finished NCT00629226 record still lists

NCT00629226 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (23% lower).

The record links to 0 conditions, and to 4 interventions - of which cisplatin is the first listed.

NCT00629226 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00629226 about?

NCT00629226 is a clinical study titled "Bortezomib, Cetuximab, and Radiation Therapy With or Without Cisplatin in Treating Patients With Stage IV Head and Neck Cancer". RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or...

What is the current status of trial NCT00629226?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 46 participants. The study started on 2007-10.

What interventions are being tested in trial NCT00629226?

The interventions under investigation include: cisplatin (DRUG), intensity-modulated radiation therapy (RADIATION), cetuximab (BIOLOGICAL), bortezomib (DRUG).

Who is sponsoring clinical trial NCT00629226?

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

How this trial's enrollment target compares

Where NCT00629226's enrollment target sits among peer trials

46 1058th of 2000 higher than 935 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 NCT00629226, the US trial registry maintained by the National Library of Medicine. NCT00629226 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.