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


Phase 2
N/A
N/A
Not Enrolling
Both
Squamous Cell Carcinoma, Head and Neck, Recurrent Disease

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Overall Response Rate of Participants

Outcome Description:

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.

Outcome Time Frame:

3.5 years

Safety Issue:

No

Principal Investigator

Matthew C Abramowitz, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Miami Sylvester Comprehensive Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

EPROST-20090467

NCT ID:

NCT01794845

Start Date:

April 2013

Completion Date:

Related Keywords:

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

Name

Location

University of Miami Sylvester Comprehensive Cancer CenterMiami, Florida  33136