Clinical trial NCT01794845: Cetuximab + Taxotere With Low Dose Fractionated Radiation for Head and Neck Carcinoma
Official title: Phase II Trial Using Erbitux+ Taxotere With Low Dose Fractionated Radiation for Recurrent Unresectable Locally Advanced Head and Neck Carcinoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Squamous Cell Carcinoma
Head and Neck Cancer
Recurrent Disease
Keywords: SCCHN
Head and Neck Cancer
Squamous Cell Carcinoma
Recurrent
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2013-02-20
Enrollment: 5
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

1. 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.
2. The recurrence must have defined bi- or uni-dimensional measurements.
3. Recurrence must be confined to the head and neck above the clavicles (loco-regional recurrence).
4. The patient must not be a candidate for surgical resection.
5. Patients must be at least 6 months from completion of prior chemotherapy and radiation therapy.
6. Patients may have received prior chemotherapy as a component of their primary treatment, but not for recurrent disease.
7. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
8. Granulocytes ≥ 1500/mm3, platelets ≥ 100,000/mm3, serum bilirubin ≤ 1.5 mg/dl, creatinine \< 1.5 mg/dl within 3 weeks prior to registration.
9. Liver Function Tests (LFTs) ≤ 2 x normal (serum glutamic oxaloacetic transaminase (SGOT)/serum glutamic-pyruvic transaminase (SGPT)/Alkaline Phosphatase). If \> 2 x normal, liver ultrasound or CT is required to exclude metastases. If negative for metastases, patients are eligible.
10. Patients must sign a study-specific informed consent form prior to study entry.

Exclusion Criteria:

1. Distant metastases outside of the head and neck.
2. Primary disease in the nasopharynx or the salivary gland.
3. Other concurrent invasive malignancies.
4. Prior invasive malignancy unless disease free for at least two years (except prior in situ malignancies, e.g. cervix, breast, non-melanomatous skin cancer, etc. are permissible).
5. Intercurrent medical illnesses which would impair patient tolerance to therapy or limit survival.
6. Pre-existing grade ≥ 2 peripheral sensory neuropathy
7. Pregnant and nursing women are excluded because of the potential teratogenic effects and potential unknown effects on nursing newborns.
8. Prior history of sever hypersensitivity reaction to Docetaxol, Cetuximab or a drug with formulated with Polysorbate 80.

Primary outcomes:
measure: Overall Response Rate (ORR) of Participants
timeFrame: Up to 6 months from End of Treatment, about 9 months
Secondary outcomes:
measure: Number of Study Participants Experiencing Treatment-Related Toxicity
timeFrame: Up to 6 years
measure: Estimated Progression-Free Survival (PFS)
timeFrame: Up to 6 years
measure: Estimated Overall Survival (OS)
timeFrame: Up to 6 years
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Matthew C Abramowitz, MD
role: PRINCIPAL_INVESTIGATOR
References: