Cetuximab and Radiation Therapy in Laryngeal Cancer Patients Who Have Responded to One Cycle of Chemotherapy (SPORE)
Cancer of Larynx
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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 With Taxotere, Cisplatin, 5-Fluorouracil (TPF), and Cetuximab|
- Percentage of Patients Achieving Histologic Complete Response [ Time Frame: 3 years ] [ Designated as safety issue: No ]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.
- The Difference, From Baseline, in EGFR, for Tumor Biopsies Taken After the Administration of Cetuximab Following TPF. [ Time Frame: Day 23 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]To evaluate the quality of life (QOL).
- Overall Survival Time [ Time Frame: 3 years ] [ Designated as safety issue: No ]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. ] [ 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.
|Study Start Date:||August 2007|
|Study Completion Date:||October 2010|
|Primary Completion Date:||July 2008 (Final data collection date for primary outcome measure)|
Patients will undergo induction chemotherapy with (TPF): Docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 on day 1, and 5-FU 750 mg/m2 days 1-4.
On day 20 patients will receive a single dose of cetuximab (C-225) 400 mg/m2.
Depending upon disease response, patients will undergo salvage laryngectomy followed by radiation therapy and chemotherapy.
1. Day 1: 100 mg/m2, administered as an i.v. infusion will run over one hour. 2. Day #23: Subjects with a < 50% response (NR) to induction chemotherapy will undergo salvage laryngectomy followed by RT. Cisplatin will be added to radiation for patients whose surgical pathology reveals high-risk features (i.e. extracapsular spread, > 2 positive lymph nodes, perineural invasion, or positive margins). Cisplatin will either be dosed a 100 mg/m2 every 21 days or 40 mg/m2 weekly at the discretion of the prescribing physician.
Other Name: Platinol®-AQDrug: Cetuximab
1. Cetuximab will be administered at 400 mg/m2 on Day 20 (2 hour administration). 2. Cetuximab will be administered in combination with radiation therapy to those subjects who had a Partial or Complete response after the first cycle of the chemotherapy regimen is administered. The dosage for these administrations is 250 mg/m2 over sixty minutes and it will be administered for six weeks.
Other Names:Drug: 5-Fluorouracil
5-FU will be administered 750 mg/m2 in 0.9% normal saline as a 24-hour continuous infusion, days #1-4.
Other Names:Drug: Docetaxel
75 mg/m2 by I.V. over one hour on Day # 1 only
Other Name: Taxotere®
Please refer to this study by its ClinicalTrials.gov identifier: NCT00599131
|United States, Michigan|
|University of Michigan Comprehensive Cancer Center|
|Ann Arbor, Michigan, United States, 48109-0848|
|Principal Investigator:||Francis P. Worden, M.D.||University of Michigan|