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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. 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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01445405
The ClinicalTrials.gov registry entry for NCT01445405 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 3 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 4 interventions - of which Cisplatin is the first listed.
NCT01445405 reports 0 study locations.
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.
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