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| Sponsor: | National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00016003 |
Purpose
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining bortezomib with radiation therapy may kill more tumor cells
PURPOSE: Phase I trial to study the effectiveness of combining bortezomib with radiation therapy in treating patients who have recurrent or metastatic head and neck cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Head and Neck Cancer |
Drug: bortezomib Radiation: radiation therapy |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Phase I Study of Concomitant Therapy With Proteasome Inhibitor PS-341 and Radiation in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck |
| Estimated Enrollment: | 51 |
| Study Start Date: | March 2001 |
| Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a dose-escalation study. Patients are stratified according to prior radiotherapy (yes vs no).
Patients receive bortezomib IV over 3-5 seconds twice weekly. Patients also receive radiotherapy on days 1-5 (days 2-5 only for the first course). Courses repeat every week for 3 weeks. Patients then receive radiotherapy alone on days 1-5 of weeks 4 and 5. Treatment with bortezomib and radiotherapy resumes in weeks 6 and 7 (for patients with prior radiotherapy) or weeks 6, 7, and 8 (for patients with no prior radiotherapy) in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of bortezomib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed at weeks 1-8, at week 12, and then monthly for 1 year.
PROJECTED ACCRUAL: A maximum of 51 patients (30 with prior radiotherapy and 21 with no prior radiotherapy) will be accrued for this study within 12 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed squamous cell carcinoma of the head and neck
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
No postural hypotension due to severe baroreceptor dysfunction after prior radiotherapy and/or surgery that is not amenable to volume repletion, defined as 1 of the following:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
More than 6 months since prior radiotherapy to the head and neck
Surgery:
Other:
Contacts and Locations| United States, Maryland | |
| NCI - Center for Cancer Research | |
| Bethesda, Maryland, United States, 20892 | |
| NIH - Warren Grant Magnuson Clinical Center | |
| Bethesda, Maryland, United States, 20892-1182 | |
| Study Chair: | Carter Van Waes, MD, PhD | National Institute on Deafness and Other Communication Disorders (NIDCD) |
More Information
| Study ID Numbers: | CDR0000068581, NCI-01-C-0104 |
| Study First Received: | May 6, 2001 |
| Last Updated: | August 27, 2009 |
| ClinicalTrials.gov Identifier: | NCT00016003 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
stage IV squamous cell carcinoma of the lip and oral cavity recurrent squamous cell carcinoma of the lip and oral cavity stage IV squamous cell carcinoma of the oropharynx recurrent squamous cell carcinoma of the oropharynx stage IV squamous cell carcinoma of the nasopharynx recurrent squamous cell carcinoma of the nasopharynx stage IV squamous cell carcinoma of the hypopharynx recurrent squamous cell carcinoma of the hypopharynx |
stage IV squamous cell carcinoma of the larynx recurrent squamous cell carcinoma of the larynx stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity recurrent salivary gland cancer salivary gland squamous cell carcinoma stage IV salivary gland cancer |
|
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Bortezomib Enzyme Inhibitors Pharmacologic Actions Carcinoma Protease Inhibitors |
Neoplasms Neoplasms by Site Head and Neck Neoplasms Therapeutic Uses Neoplasms, Squamous Cell Carcinoma, Squamous Cell Neoplasms, Glandular and Epithelial |