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NCT01445405 · ClinicalTrials.gov registry record · Phase 1
Radiation Therapy and Bortezomib and Cetuximab With or Without Cisplatin to Treat Head and Neck Cancer
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 3
- Enrollment target
NCT01445405: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT01445405 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 3 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01445405, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 3 participants
- Enrollment target
Study Summary
Background: Bortezomib acts on molecules in head and neck cancer cells that are important for the cells growth and survival. The drug may help make the cancer more sensitive to radiation and other chemotherapy drugs. Cetuximab is a monoclonal antibody that has increased the effectiveness of radiation treatment in patients with head and neck cancer in clinical trials. Cisplatin has shrunk head and neck cancers and improved treatment response and survival when combined with radiation treatment. Objectives: To determine the highest safe dose of bortezomib when combined with cetuximab without or with cisplatin and with radiation in patients with advanced head and neck cancer. To examine the benefits and side effects of these drug combinations with radiation in patients with advanced head and neck cancer. Eligibility: Patients 18 years of age and older with advanced Stage IV head and neck cancer who have not previously had neck radiation. Design: Patients will be assigned sequentially to one of two treatment groups: Group A receives bortezomib and cetuximab beginning the week before, and for the duration of, radiation therapy; Group B receives bortezomib, cetuximab and cisplatin beginning the week before, and for the duration of, radiation therapy. * Cetuximab is given as a 2-hour infusion through a vein (intravenously, IV) for the first dose and then over 1 hour for subsequent weekly doses. * Bortezomib is given as an injection into a vein over about 5 seconds, twice a week for 2 weeks, followed by a 1-week rest for a total of three 3-week treatment cycles during radiation. * Cisplatin is given in once a week as a 1-hour IV infusion * Radiation therapy is given 5 days a week for 7 to 8 weeks. Post-treatment follow-up: * Until 2 weeks after treatment ends, patients are followed once a week including a physical examination, review of treatment side effects, and blood tests. * For 2 months after treatment ends, patients may need to return to the hospital for m
Interventions
- DRUG Cisplatin
- DRUG Cetuximab
- PROCEDURE Radiation Therapy
- DRUG Bortezomib (Velcade, PS-341)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2008-02-05 |
| Est. Completion | 2010-08-27 |
| Phase | Phase 1 |
What the finished NCT01445405 record still lists
NCT01445405 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 4 interventions - of which Cisplatin is the first listed.
NCT01445405 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01445405 about?
NCT01445405 is a clinical study titled "Radiation Therapy and Bortezomib and Cetuximab With or Without Cisplatin to Treat Head and Neck Cancer". Background: Bortezomib acts on molecules in head and neck cancer cells that are important for the cells growth and survival. The drug may help make the cancer more sensitive to radiation and other chemotherapy drugs. Cetuximab is a monoclonal antibody that has increased the effectiveness of radiat...
What is the current status of trial NCT01445405?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2008-02-05. Estimated completion is 2010-08-27.
What interventions are being tested in trial NCT01445405?
The interventions under investigation include: Cisplatin (DRUG), Cetuximab (DRUG), Radiation Therapy (PROCEDURE), Bortezomib (Velcade, PS-341) (DRUG).
Who is sponsoring clinical trial NCT01445405?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01445405's enrollment target sits among peer trials
3 1999th of 2000 higher than 1 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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