Overview

This trial is active, not recruiting.

Conditions squamous cell head and neck carcinoma, recurrent or metastatic disease
Treatments cetuximab iv, biopsies
Phase phase 2
Sponsor Groupe Oncologie Radiotherapie Tete et Cou
Collaborator Gustave Roussy, Cancer Campus, Grand Paris
Start date September 2009
End date January 2014
Trial size 54 participants
Trial identifier NCT01289522, 2008-004869-25, GORTEC2008-03TPex

Summary

PURPOSE: Cetuximab with platinum and 5FU is now the standard combination as first-line treatment in patients with metastatic or recurrent Head and Neck squamous cell carcinomas. Cetuximab and taxane combinations have demonstrated promising activity in Head and Neck cancer. This phase II trial is studying new cetuximab, docetaxel and cisplatin combination named TPEx as first-line treatment in this setting.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Patients receive four cycles of chemotherapy comprising cetuximab IV plus docetaxel IV over 1 hour and cisplatin IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. After completion of the fourth cycle of chemotherapy, patients receive a maintenance therapy with cetuximab every 2 weeks. Treatment will be continued until disease progression or unacceptable toxicities according
cetuximab iv
Cetuximab 400 mg/m² over 120 minutes on day 1 of cycle 1 only. Cetuximab dose will be 250 mg/m² IV over 60 minutes weekly on subsequent administrations during the four cycles of chemotherapy. Cetuximab dose will be 500mg/m2 IV every 2 weeks during the maintenance therapy. Drug: Cisplatin IV : 75 mg/m2 intravenous every 3 weeks for 4 cycles Drug: Docetaxel IV : 75 mg/m2 intravenous every 3 weeks for 4 cycles G-CSF support with lenograstim 150 microg./m2/day is delivered after each cycle of chemotherapy.
biopsies
No intervention, only biopsy for translational project.

Primary Outcomes

Measure
objective tumor response rate
time frame: 12 weeks (after completion of the fourth cycle of chemotherapy)

Secondary Outcomes

Measure
Grade 1 to 5 toxicity
time frame: 24 weeks (average)
best overall response
time frame: 12 weeks
progression-free survival
time frame: 1 year
overall survival
time frame: 1 year
biomarkers
time frame: two years

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

Inclusion Criteria: - Histologically proven squamous cell carcinoma of the oral cavity, larynx, oropharynx or hypopharynx - Recurrent disease, incurable disease as determined by surgery or radiation, or metastatic disease - Measurable or evaluable disease - Age > 18 years and <= 70 years - WHO performance status 0 or 1 - Absolute neutrophil count > 1,500/mm3 - Platelets > 150,000/mm3 - Total Bilirubin <= institutional upper limit of normal - Aspartate aminotransferase < 1.5 X institutional upper limit of normal - Alanine aminotransferase < 1.5 X institutional upper limit of normal - Alkaline phosphatase < 2.5 X institutional upper limit of normal - creatinine clearance > 60 mL/min - Signed informed consent - Women of child-bearing potential and men must be willing and able practice adequate contraception prior to study entry and for the duration of study treatment Exclusion Criteria: - Previous chemotherapy. Chemotherapy given as part of initial curative therapy and completed more than 6 months before inclusion is allowed - Previous treatment with total doses of cisplatin > 300 mg/ m2 - Patients must not have any co-existing disease that would preclude cisplatin administration, such as peripheral neuropathy or renal failure - Surgery (excluding biopsy) or radiotherapy within 4 weeks prior to study entry - Nasopharyngeal carcinoma, or cancer of sinusal cavities - Active infection including tuberculosis or HIV positive patient - Other malignancy within last 5 years except for non-melanoma skin cancer - No other investigational agent within 30 days prior to study entry - No other concurrent chemotherapy, immunotherapy, antitumor hormonal therapy (excluding contraceptives and replacement steroids), radiotherapy, or experimental medications - No prior anti EGFR therapy - No known brain metastases - Uncontrolled intercurrent illness that would prevent delivery of protocol therapy - Patients with a prior history of basal cell carcinoma of the skin or in situ carcinoma of the cervix must have been curatively treated and must have remained disease free for 5 years post diagnosis - No history of hypersensitivity reaction to drugs on study - No unstable angina or myocardial infarction within the past 12 months - No symptomatic congestive heart failure or New York Heart Association (NYHA) class II-IV heart disease - No serious uncontrolled cardiac arrhythmia - No other prior or concomitant squamous cell carcinoma - No other prior or concomitant cancer, except curatively treated basal carcinoma of the skin or in situ cervical cancer, for which the patient has been curatively treated and remains disease-free for the past 5 years - Patient is pregnant or lactating - Patients must not have any co-existing condition that would preclude full compliance with the study

Additional Information

Official title Phase II Study of Cetuximab, Docetaxel and Cisplatin as First-line Treatment in Patients With Metastatic or Recurrent Head and Neck Squamous Cell Carcinomas - GORTEC2008-03 TPEx
Description OBJECTIVES: Primary - To determine the efficacy of TPEx combination in patients with head and neck cancer in term of objective response rate (RECIST, see statistical consideration) Secondary - To assess toxicities of TPEx combination - Determine the efficacy of TPEx combination in patients with head and neck cancer: Best Overall Response , progression-free survival and survival. - Translational research objective:To better understand the mechanisms of chemoresistance and to identify biomarkers by the analysis of the tumor biopsies (RNA, gene expression profile) and protein profile (plasma samples). Exploratory analyses. OUTLINE: This is an open-label phase II, multicenter study. Patients receive four cycles of chemotherapy comprising cetuximab IV plus docetaxel IV over 1 hour and cisplatin IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. After completion of the fourth cycle of chemotherapy, patients receive a maintenance therapy with cetuximab every 2 weeks. Treatment will be continued until disease progression or unacceptable toxicities according to the patient or the investigator. Tumor check-up will be performed every 6 weeks. This study will allow translational research with blood sample and biopsies at baseline before any treatment, during the treatment with TPEx combination (week 6).,After completion of study treatment, patients are followed every 2 months.
Trial information was received from ClinicalTrials.gov and was last updated in January 2014.
Information provided to ClinicalTrials.gov by Groupe Oncologie Radiotherapie Tete et Cou.