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NCT00033449 · ClinicalTrials.gov registry record · Phase 1

Gefitinib and Radiation Therapy With or Without Cisplatin in Treating Patients With Stage III or Stage IV Head and Neck Cancer

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

Terminated
Registry status
Phase 1
Development phase
30
Enrollment target

NCT00033449: Clinical Trial Phase 1 study, sponsored by National Cancer Institute (NCI).

NCT00033449 is a Phase 1 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00033449, a Phase 1 study, was terminated before completion, sponsored by National Cancer Institute (NCI).

TERMINATED
Registry status
Phase 1
Development phase
30 participants
Enrollment target

Study Summary

This phase I trial is studying the side effects and best dose of gefitinib when given together with radiation therapy with or without cisplatin in treating patients with stage III or stage IV head and neck cancer. Biological therapies such as gefitinib may interfere with the growth of tumor cells and slow the growth of cancer. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining gefitinib and radiation therapy with cisplatin may kill more tumor cells

Primary Outcome

Descriptive statistics (mean, median, range, standard deviation \[s.d.\], percentage, as appropriate) will be obtained.

Interventions

  • OTHER laboratory biomarker analysis
  • DRUG cisplatin
  • RADIATION radiation therapy
  • DRUG gefitinib

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2002-02
Phase Phase 1
National Cancer Institute (NCI)

3,257 total trials

Why NCT00033449 stopped before completion

NCT00033449 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).

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

NCT00033449 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00033449 about?

NCT00033449 is a clinical study titled "Gefitinib and Radiation Therapy With or Without Cisplatin in Treating Patients With Stage III or Stage IV Head and Neck Cancer". This phase I trial is studying the side effects and best dose of gefitinib when given together with radiation therapy with or without cisplatin in treating patients with stage III or stage IV head and neck cancer. Biological therapies such as gefitinib may interfere with the growth of tumor cells an...

What is the current status of trial NCT00033449?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2002-02.

What interventions are being tested in trial NCT00033449?

The interventions under investigation include: laboratory biomarker analysis (OTHER), cisplatin (DRUG), radiation therapy (RADIATION), gefitinib (DRUG).

Who is sponsoring clinical trial NCT00033449?

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 NCT00033449's enrollment target sits among peer trials

30 1332nd of 2000 higher than 561 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 NCT00033449, the US trial registry maintained by the National Library of Medicine. NCT00033449 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.