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

NCT ID: NCT01794845

Last Updated: 2017-05-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-03
• Study Completion Date: 2016-06-07

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.

Conditions

Squamous Cell Carcinoma; Head and Neck Cancer; Recurrent Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Erbitux, Taxotere, LD Fractionated RT

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

Group Type: EXPERIMENTAL

Erbitux

Intervention Type: DRUG

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

Intervention Type: DRUG

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

Low Dose Fractionated Radiation Therapy

Intervention Type: RADIATION

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.

Interventions

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 Day 1 of treatment week following Taxotere.

Intervention Type: DRUG

Taxotere

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

Intervention Type: DRUG

Low Dose Fractionated Radiation Therapy

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.

Intervention Type: RADIATION

Other Intervention Names

Cetuximab; Docetaxel; LDFRT

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Matthew Abramowitz

Assistant Professor of Clinical

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Matthew C Abramowitz, MD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

University of Miami

Miami, Florida, United States

Countries

United States

Other Identifiers

20090467

Identifier Type: -

Identifier Source: org_study_id