Head and Neck Cancer Clinical Trial
Official title:
Phase I Study of Bortezomib and Cetuximab Without or With Cisplatin in Combination With Radiation Therapy for Advanced 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 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.
OBJECTIVES:
Primary
- To evaluate the feasibility and toxicity of bortezomib, cetuximab, and radiotherapy
with or without cisplatin in patients with stage IV squamous cell carcinoma of the head
and neck.
- To identify the maximum tolerated dose of bortezomib for further clinical phase II
development.
Secondary
- To evaluate the objective response rate, progression-free survival, and overall
survival of patients treated with these regimens.
- To determine the effects of bortezomib and cetuximab with or without cisplatin on
inhibiting activation of the NF-kB, EGFR, MAPK, and STAT3 signal pathways, expression
of pro-survival and pro-angiogenesis genes regulated by these pathways, and on
proliferation, apoptosis, and angiogenesis.
OUTLINE: This is a multicenter, dose-escalation study of bortezomib. Patients are
simultaneously accrued to 1 of 2 treatment groups. Patients are initially accrued to group I
until there are a sufficient number of patients to establish the maximum tolerated dose
(MTD) of bortezomib. Patients are then accrued to group II.
- Group I: Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, 36, 43,
and 50. Patients also receive bortezomib IV over 3-5 seconds on days 1, 4, 8, 11, 22,
25, 29, 32, 43, 46, 50, and 53. Beginning on day 8 or 9, patients undergo standard
intensity-modulated radiotherapy (IMRT) once daily, 5 days a week, for up to 8 weeks.
Once the MTD of bortezomib is determined, at least 6 and up to 10 additional patients are
accrued and treated at the MTD.
- Group II: Patients receive cetuximab, bortezomib (beginning at one dose level below the
MTD determined in group I), and IMRT as in group I. Patients also receive cisplatin IV
over 1 hour on days 1, 8, 15, 22, 29, 36, 43, 50, and 57.
Once the MTD of bortezomib is determined, 6 additional patients are accrued and treated at
the MTD.
Patients undergo blood sample collection periodically for correlative laboratory studies.
Samples are analyzed for biomarkers by immunohistochemistry, quantitative reverse
transcriptase-polymerase chain reaction, and ELISA.
After completion of study therapy, patients are followed periodically for 2-5 years.
;
Primary Purpose: Treatment
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