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Cetuximab and Radiation Therapy in Laryngeal Cancer Patients Who Have Responded to One Cycle of Chemotherapy (SPORE)
This study is ongoing, but not recruiting participants.
Study NCT00599131   Information provided by University of Michigan Cancer Center
First Received: December 12, 2007   Last Updated: May 8, 2008   History of Changes

December 12, 2007
May 8, 2008
August 2007
May 2008   (final data collection date for primary outcome measure)
Determine rates of histologic complete response (CR) as compared to historical controls. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00599131 on ClinicalTrials.gov Archive Site
  • To determine tumor EGFR degradation, as well as other markers of down-stream EGFR inhibition, observed in tumor biopsies taken shortly after the administration of cetuximab following TPF, compared with pre-treatment biopsies. [ Time Frame: 3 years. ] [ Designated as safety issue: No ]
  • To evaluate the quality of life (QOL). [ Time Frame: 3 years. ] [ Designated as safety issue: No ]
  • To determine the overall survival rates compared to the overall survival rates of historical controls. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • To determine and compare toxicities, most notably mucositis and dysphagia, in patients on this treatment regimen as compared to historical controls. [ Time Frame: 3 years. ] [ Designated as safety issue: No ]
Same as current
 
Cetuximab and Radiation Therapy in Laryngeal Cancer Patients Who Have Responded to One Cycle of Chemotherapy (SPORE)
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

The purpose of this study is to learn how to identify early which patients will respond to chemotherapy plus radiation therapy in order to reduce the number of subjects who require surgery (followed by radiation therapy).

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.

Phase II
Interventional
Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Cancer of Larynx
  • Drug: Cisplatin
  • Drug: Cetuximab
  • Drug: 5-Fluorouracil
  • Drug: Docetaxel
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
100
June 2010
May 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00599131
Francis P.Worden, M.D., Clinical Assistant Professor, University of Michigan
UMCC 2007.029
University of Michigan Cancer Center
 
Principal Investigator: Francis P. Worden, M.D. University of Michigan
University of Michigan Cancer Center
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP