Whether low-dose radiation in addition to Taxotere and Erbitux improves the response rate of patients with recurrent unresectable head and neck squamous cell carcinoma.
The investigator's approach is based on the following reasons: * Low dose hyper-radiation sensitivity response will be significantly enhanced in Taxotere- induced G2/M cell cycle arrest. * LDFRT will render enhanced bax activation mediated mode of cell death. * Erbitux will arrest the cells in G1/G0 phase leading to p21-mediated mode of cell death. * The toxicity profile is expected to be minimal. Based on the above mentioned reasons, we propose this novel schema of treatment in recurrent SCCHN.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
5
Erbitux: 400 mg/m2 as a loading dose one week prior to radiation and taxotere, and then at 250 mg/m2 given weekly on Day 1 of treatment week following Taxotere.
Taxotere : 20 mg/m2 IV once a week on Day 1 during treatment weeks 2 to 7.
Low-dose fractionated Radiation (LDFRT): 0.5 Gy per fraction twice-a-day (BID) at least 6 to 8 hours apart on Days 2 and 3 of treatment weeks 2 to 7 for a total dose of 12 Gy.
University of Miami
Miami, Florida, United States
Overall Response Rate (ORR) of Participants
ORR is defined as the rate of study participants achieving complete response (CR) or partial response (PR) to protocol therapy according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) criteria.
Time frame: Up to 6 months from End of Treatment, about 9 months
Number of Study Participants Experiencing Treatment-Related Toxicity
Assess the safety profile (acute and late toxicities) of the proposed treatment. Number of study participants experiencing treatment-related acute and late toxicity: * Acute toxicity is defined as toxicity occurring within 90 days of start of therapy. * Late/Long-term toxicity defined as toxicity occurring more than 90 days after start of therapy.
Time frame: Up to 6 years
Estimated Progression-Free Survival (PFS)
Progression-free survival (PFS) is defined of the length of time from the start date of treatment to the earliest documented occurrence of disease progression according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) criteria. In the absence of an event constituting failure, follow up time will be censored at the date of last disease assessment.
Time frame: Up to 6 years
Estimated Overall Survival (OS)
Overall survival (OS) is defined as the length of time from the start of treatment that study participants diagnosed with the disease are still alive. OS will be measured from the start date of treatment to the date of death or last contact (censored observations).
Time frame: Up to 6 years
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