Cetuximab and Combination Chemotherapy in Treating Patients With Stage III or Stage IV Oropharynx Cancer That Can Be Removed by Surgery
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|ClinicalTrials.gov Identifier: NCT00665392|
Recruitment Status : Completed
First Posted : April 23, 2008
Last Update Posted : August 22, 2012
RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as docetaxel, cisplatin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) together with cetuximab may kill more tumor cells.
PURPOSE: This phase II clinical trial is studying how well cetuximab given together with combination chemotherapy works in treating patients with stage III or stage IV oropharynx cancer that can be removed by surgery.
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer||Drug: cisplatin Drug: docetaxel Drug: fluorouracil Drug: Cetuximab||Phase 2|
- To determine the complete clinical response rate at 3 months in patients with stage III or IV nonmetastatic squamous cell carcinoma of the oropharynx treated with cetuximab, docetaxel, cisplatin, and fluorouracil.
- To determine the rate of tumor response.
- To determine progression-free and overall survival.
- To determine the rate of complete pathological response.
- To assess the tolerability of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive cetuximab IV over 1-2 hours on days 1, 8, and 15; docetaxel IV over 1 hour and cisplatin IV over 1 hour on day 1; and fluorouracil IV continuously on days 1-5. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed every 2 months for 1 year and every 3 months for 2 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Induction Chemotherapy With Cetuximab, Docetaxel, Cisplatin, and Fluorouracil (ETPF)for Squamous Cell Carcinoma of the Oropharynx That is Operable Stage III-IV|
|Study Start Date :||February 2008|
|Actual Primary Completion Date :||July 2012|
|Actual Study Completion Date :||July 2012|
75 mg/m², day 1. 3 cyclesDrug: docetaxel
75 mg/m² Day 1. 3 cyclesDrug: fluorouracil
750 mg/m² day 1 to day 5. 3 cyclesDrug: Cetuximab
400 mg/m² Day 1, 250 mg/m² Day 8 and Day 15. 3 cycles.
- Complete clinical response rate at 3 months [ Time Frame: at 3 months ]
- Rate of response (partial and complete response and stable disease) [ Time Frame: at 3 months ]
- Progression-free survival [ Time Frame: from inclusion to first disease progression with chemotherapy ]
- Overall survival [ Time Frame: From inclusion to patient's decease ]
- Pathologic response [ Time Frame: after surgery of the primary tumor ]On primary tumor resected : measure of persistence or not of tumoral lesion, histological type, size and quality of the excision piece
- Tolerability [ Time Frame: until 1 month after the last administration ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00665392
|Hôpital Simone Veil|
|Montmorency, France, 95160|
|Hôpital Privé St Joseph|
|Paris, France, 75014|
|Hopital Europeen Georges Pompidou|
|Paris, France, 75015|
|Hopital Bichat - Claude Bernard|
|Paris, France, 75018|
|Paris, France, 75970|
|centre Hospitalier Lyon Sud|
|Pierre Benite, France, 69495|
|Centre René Huguenin|
|Saint Cloud, France, 92100|
|Suresnes, France, 92151|
|Principal Investigator:||Jean Lacau Saint Guily, MD||Hopital Tenon|