Cetuximab and Radiation Therapy in Laryngeal Cancer Patients Who Have Responded to One Cycle of Chemotherapy (SPORE)
|ClinicalTrials.gov Identifier: NCT00599131|
Recruitment Status : Terminated (The study was discontinued prematurely due to early stopping rules.)
First Posted : January 23, 2008
Results First Posted : June 16, 2014
Last Update Posted : December 3, 2015
|Condition or disease||Intervention/treatment||Phase|
|Cancer of Larynx||Drug: Cisplatin Drug: Cetuximab Drug: 5-Fluorouracil Drug: Docetaxel||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||August 2007|
|Actual Primary Completion Date :||July 2008|
|Actual Study Completion Date :||October 2010|
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®
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|