Clinical Trial: Cetuximab and Radiation Therapy in Laryngeal Cancer Patients Who Have Responded to One Cycle of Chemotherapy (SPORE)

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: 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 W

Brief Summary: 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).

Detailed Summary: 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.
Sponsor: University of Michigan Cancer Center

Current Primary Outcome: Percentage of Patients Achieving Histologic Complete Response [ Time Frame: 3 years ]

The proportion of patients treated with radiation+cetuximab achieving histologic CR will be estimated, along with 95% exact confidence intervals. Histologic Complete Response (CR) will be defined as primary tumors exhibiting a clinical CR or at least a 90% PR (Partial Response) along with a negative post-treatment biopsy.


Original Primary Outcome: Determine rates of histologic complete response (CR) as compared to historical controls. [ Time Frame: 3 years ]

Current Secondary Outcome:

  • The Difference, From Baseline, in EGFR, for Tumor Biopsies Taken After the Administration of Cetuximab Following TPF. [ Time Frame: Day 23 ]
    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.
  • The Change in Overall Quality of Life Score During Radiation Therapy and at 6, 12, and 24 Months Post Treatment. [ Time Frame: 24 months ]
    To evaluate the quality of life (QOL).
  • Overall Survival Time [ Time Frame: 3 years ]
    To determine the overall survival rates compared to the overall survival rates of historical controls.
  • The Number of Patients That Experience Grade 3 and 4 Mucositis or Dysphagia [ Time Frame: 3 years. ]
    To determine and compare toxicities, most notably mucositis and dysphagia, in patients on this treatment regimen as compared to historical controls.


Original Secondary Outcome:

  • 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. ]
  • To Evaluate the Quality of Life (QOL). [ Time Frame: 3 years. ]
  • To Determine the Overall Survival Rates Compared to the Overall Survival Rates of Historical Controls. [ Time Frame: 3 years ]
  • 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. ]


Information By: University of Michigan Cancer Center

Dates:
Date Received: December 12, 2007
Date Started: August 2007
Date Completion:
Last Updated: November 4, 2015
Last Verified: November 2015