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

Phase 2

Terminated

• Conditions: Squamous Cell Carcinoma; Recurrent Disease; Head and Neck Cancer
• Interventions: Drug: Erbitux; Drug: Taxotere; Radiation: Low Dose Fractionated Radiation Therapy

• Registration Number: NCT01794845
• Lead Sponsor: University of Miami

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.

Study Timeline

• Study First Submitted: 2013-02-14
• Study First Submitted QC: 2013-02-19
• Study First Posted: 2013-02-20
• Study Start: 2013-06-03
• Primary Completion: 2016-06-07
• Study Completion: 2016-06-07
• Results First Submitted: 2017-02-08
• Status Verified: 2017-03
• Results First Submitted QC: 2017-03-31
• Last Update Submitted: 2017-03-31
• Results First Posted: 2017-05-11
• Last Update Posted: 2017-05-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Erbitux, Taxotere, LD Fractionated RT	Erbitux	Erbitux, Taxotere and Low Dose Fractionated Radiation Therapy (LDFRT)
Erbitux, Taxotere, LD Fractionated RT	Low Dose Fractionated Radiation Therapy	Erbitux, Taxotere and Low Dose Fractionated Radiation Therapy (LDFRT)
Erbitux, Taxotere, LD Fractionated RT	Taxotere	Erbitux, Taxotere and Low Dose Fractionated Radiation Therapy (LDFRT)

Primary Outcome Measures

Name	Time	Method
Overall Response Rate (ORR) of Participants	Up to 6 months from End of Treatment, about 9 months	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.

Secondary Outcome Measures

Name	Time	Method
Estimated Progression-Free Survival (PFS)	Up to 6 years	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.
Number of Study Participants Experiencing Treatment-Related Toxicity	Up to 6 years	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.
Estimated Overall Survival (OS)	Up to 6 years	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).

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States