Symptoms and General Pathology

All Conditions

Neoplasms

Recurrence

Carcinoma

Carcinoma, Squamous Cell

Head and Neck Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Disease Attributes

Neoplasms, Squamous Cell

Antineoplastic Agents

All Drugs and Chemicals

Docetaxel

Cetuximab

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Immunological

Erbitux, Taxotere and Low Dose Fractionated Radiation Therapy (LDFRT)

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.

Erbitux

Taxotere : 20 mg/m2 IV once a week on Day 1 during treatment weeks 2 to 7.

Taxotere

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.

Low Dose Fractionated Radiation Therapy

Matthew C Abramowitz, MD

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.

Cetuximab + Taxotere With Low Dose Fractionated Radiation for Head and Neck Carcinoma

Phase II Trial Using Erbitux+ Taxotere With Low Dose Fractionated Radiation for Recurrent Unresectable Locally Advanced Head and Neck Carcinoma

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.

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.

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.

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).

University of Miami

Assistant Professor of Clinical

Erbitux, Taxotere and Low Dose Fractionated Radiation Therapy (LDFRT):

* 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.

Erbitux, Taxotere, LD Fractionated RT

Data for 4 of 5 participants analyzed due to 1 subject withdrawing prior to receiving protocol therapy.

Age, Categorical

Sex: Female, Male

United States

Region of Enrollment

Site of Head and Neck Carcinoma

Number of study participants receiving surgery as treatment for primary tumor.

Surgery

Number of study participants receiving chemotherapy as treatment for primary tumor.

Chemotherapy

Data analyzed for 4 out of 5 study participants due to 1 study participant withdrawing prior to receiving study therapy.

Matthew C. Abramowitz MD

Overall Response (CR+PR), 1 month

Overall Response (CR+PR), 6 months

Complete Response (CR), 1 month

Complete Response (CR), 6 months

Partial Response (PR), 1 month

Partial Response (PR), 6 months

Stable Disease (SD), 1 month

Stable Disease (SD), 6 months

Progressive Disease (PD), 1 month

Progressive Disease (PD), 6 months

Overall Response Rate (ORR) of Participants

Acute Toxicities

Late Toxicities

Number of Study Participants Experiencing Treatment-Related Toxicity

At the time of study termination in June 2016, 1 patient had already died, 1 patient had refused follow-up, 1 patient was lost to follow-up and 1 patient was alive with disease. Progression-free survival data were not analyzed due to an insufficient number of evaluable participants accrued and early study termination for lack of efficacy.

Estimated Progression-Free Survival (PFS)

At the time of study termination in June 2016, 1 patient had already died, 1 patient had refused follow-up, 1 patient was lost to follow-up and 1 patient was alive with disease. Overall survival data were not analyzed due to an insufficient number of evaluable participants accrued and early study termination for lack of efficacy.

Spots Global Cancer Trial Database for low dose fractionated radiation therapy