Know Cancer

or
forgot password

A Phase II Organ Preservation Trial Using Cetuximab and Radiation Therapy in Advanced Laryngeal Cancer Patients Who Have Responded to One Cycle of Induction Chemotherapy With Taxotere, Cisplatin, 5-Fluorouracil (TPF), and Cetuximab


Phase 2
18 Years
N/A
Not Enrolling
Both
Cancer of Larynx

Thank you

Trial Information

A Phase II Organ Preservation Trial Using Cetuximab and Radiation Therapy in Advanced Laryngeal Cancer Patients Who Have Responded to One Cycle of Induction Chemotherapy With Taxotere, Cisplatin, 5-Fluorouracil (TPF), and Cetuximab


In this study one cycle of chemotherapy will be administered and then those subjects who
respond well to that cycle will be started on radiation therapy along with chemotherapy and
those that don't respond well to the initial cycle of chemotherapy, will undergo a total
laryngectomy (surgery to remove the voice box) followed by radiation therapy. The initial
cycle of chemotherapy consists of the drugs Taxotere, Cisplatin, and 5-Fluorouracil (this
combination is known as TPF). Then on Day 20 of the study, the subjects will be administered
another chemotherapy agent called cetuximab (a.k.a. C-225). It will then be determined if
the patient's response to the chemotherapy was favorable by examining the patient's tumor
with an endoscopy. If the response is determined to be good, then the patient will continue
with a chemotherapy regimen with the addition of radiation therapy combination. If the
patient's response to the chemotherapy is determined to be less than favorable, then the
patient will be advised to undergo salvage surgery (a.k.a. laryngectomy) to remove their
voice box and then undergo radiation therapy treatment. Additionally, tumor tissue samples
and blood will be studied to see if there are special molecular markers that help predict
when a tumor will respond to chemotherapy and radiation treatment.


Inclusion Criteria:



- Patients must have pathologically confirmed, previously untreated, resectable,
squamous cell carcinoma of the larynx.

- Disease must be Stage III or IV.

- Tumor must be potentially surgically resectable and curable with conventional surgery
and radiation therapy.

- Patients must undergo pre-treatment endoscopic tumor staging and CT scanning.

- ECOG Performance status 0-2

- Pre-treatment laboratory criteria:

- WBC > or = to 3500/ul, granulocyte > or = to 1500/ul.

- Platelet count > or equal to 100,000/ul.

- Calculated or measured creatinine clearance > or = to 60 cc/min.

- Total Bilirubin < or = to 1.5 X ULN.

- AST and ALT < or = to 2.5 X ULN.

- Patients must give documented informed consent to participate in this study.

Exclusion Criteria:

- Prior head and neck malignancy or history of other prior non-head and neck malignancy
within the past 3 years.

- Prior head and neck radiation or prior chemotherapy.

- Documented evidence of distant metastases.

- Active infection.

- Pregnancy or lactation. Patients must agree to use adequate contraception (hormonal
or barrier method of birth control) prior to study entry, for the duration of study
participation and for 3 months after discontinuing therapy.

- Any medical or psychiatric illness which in the opinion of the principal investigator
would compromise the patients ability to tolerate this treatment.

- Patients residing in prison.

- Age < 18 years.

- Patients with psychiatric/social situations that would limit compliance with study
requirements are not eligible.

- Patients with prior radiation to the head and neck.

- Patients with prior anti-epidermal growth-factor receptor antibody therapy or therapy
with a tyrosine-kinase inhibitor.

- Patients with Grade > 2 peripheral neuropathy.

- Any history of severe hypersensitivity reaction to docetaxel or other drugs
formulated with polysorbate 80.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine rates of histologic complete response (CR) as compared to historical controls.

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

Francis P. Worden, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Michigan

Authority:

United States: Institutional Review Board

Study ID:

UMCC 2007.029

NCT ID:

NCT00599131

Start Date:

August 2007

Completion Date:

October 2010

Related Keywords:

  • Cancer of Larynx
  • Cancer of Larynx
  • Laryngeal Neoplasms

Name

Location

University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752