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

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01794845
• Other study ID #: 20090467
• Status: Completed
• Phase: Phase 2
• First received: February 14, 2013
• Last updated: August 8, 2016
• Start date: May 2013

Study information

• Verified date: August 2016
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients must have pathologically confirmed recurrence (reappearance of previously cleared) squamous cell cancer primary in the upper aerodigestive tract .Patients may have experienced more than one recurrence as long as the first recurrence occurred = 6 months following the end of the prior RT.

• The recurrence must have defined bi- or uni-dimensional measurements.

• Recurrence must be confined to the head and neck above the clavicles (loco-regional recurrence).

• The patient must not be a candidate for surgical resection.

• Patients must be at least 6 months from completion of prior chemotherapy and radiation therapy.

• Patients may have received prior chemotherapy as a component of their primary treatment, but not for recurrent disease.

• ECOG performance status 0-2.

• Granulocytes >= 1500/mm3, platelets >= 100,000/mm3, serum bilirubin =< 1.5 mg/dl, creatinine < 1.5 mg/dl within 3 weeks prior to registration.

• LFT's = 2 x normal (SGOT/SGPT/Alkaline Phosphatase).If > 2 x normal, liver ultrasound or CT is required to exclude metastases. If negative for metastases, patients are eligible.

• Patients must sign a study-specific informed consent form prior to study entry

Exclusion Criteria:

• Distant metastases outside of the head and neck.

• Primary disease in the nasopharynx or the salivary gland.

• Other concurrent invasive malignancies.

• Prior invasive malignancy unless disease free for at least two years (except prior in situ malignancies, e.g. cervix, breast, non-melatomatous skin cancer, etc. are permissible).

• Intercurrent medical illnesses which would impair patient tolerance to therapy or limit survival.

• Pre-existing grade = 2 peripheral sensory neuropathy

• Pregnant and nursing women are excluded because of the potential teratogenic effects and potential unknown effects on nursing newborns.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Head and Neck Cancer
• Head and Neck Neoplasms
• Recurrent Disease
• Squamous Cell Carcinoma

Intervention

Drug:
• Erbitux
Erbitux: 400 mg/m2 as a loading dose one week prior to radiation and taxotere, and then at 250 mg/m2 given weekly on Mondays.
• Taxotere
Taxotere : 20 mg/m2 IV once a week on Mondays on weeks 2 to 7 in 500 cc ½ normal saline solution (NSS) or D5W over 60 minutes. Additional intravenous fluids pre- or post-Taxotere can be administered as necessary.

Radiation:
• Low Dose Fractionated Radiation Therapy
Low-dose fractionated Radiation (LDFRT): 0.5 Gy per fraction BID at least 6 hours apart on Tuesday and Wednesday of weeks 2 to 7 for a total dose of 12 Gy.

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Response Rate of Participants	The primary objective is to show improvement of the overall response rate from the current standard of 40% with chemotherapy alone, to 70% with the addition of LDFRT, in patients with recurrent unresectable head and neck squamous cell carcinoma.	3.5 years	No
Secondary	Number of Participants Experiencing Adverse Events	Assess the safety profile (acute and late toxicities) of the proposed treatment	3.5 years	Yes
Secondary	Progression-Free Survival		3.5 years	No
Secondary	Overall Survival		3.5 years	No