Chemotherapy With Cetuximab in Treating Patients With Recurrent or Metastatic Head and Neck Cancer

NCT01289522 | Completed Phase 2 Results

• 2 other identifiers: GORTEC 2008-03 TPEx2008-004869-25
• Study Type: interventional
• Target: 54
• Locations: 2 countries
• Sites: 14

Brief 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.

Conditions

Squamous Cell Head and Neck Carcinoma; Recurrent or Metastatic Disease

Keywords

Squamous cell carcinoma of the head and neck; recurrent or metastatic; first line chemotherapy; cetuximab; docetaxel; cisplatin; antineoplastic agents; First Line Palliative Treatment

Outcome Measures

Primary Outcomes (1)

• Objective Tumor Response Rate

  The objective tumor response rate is evaluated every 6 weeks according to RECIST criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT-scan or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR.

  12 weeks (after completion of the 4th cycle of chemotherapy)

Secondary Outcomes (5)

• Grade 1 to 5 Toxicity

  24 weeks (average)

• Best Overall Response

  12 weeks

• Progression-free Survival

  1 year

• Overall Survival

  1 year

• Biomarkers

  two years

Study Arms (1)

cetuximab

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

Biological: cetuximab IV; Other: Biopsies

Interventions

cetuximab IV BIOLOGICAL

* 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.

cetuximab

Biopsies OTHER

No intervention, only biopsy for translational project.

cetuximab

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Groupe Oncologie Radiotherapie Tete et Cou: lead
• Gustave Roussy, Cancer Campus, Grand Paris: collaborator

Study Sites (14)

Cliniques Universitaires

Brussels, Belgium

Location

Clinique Sainte Elisabeth

Namur, Belgium

Location

Clinique universitaire de Mont Godinne UCL

Yvoir, Belgium

Location

Hôpital Saint André

Bordeaux, France

Location

Centre Jean Perrin,

Clermont-Ferrand, France

Location

Centre G-F Leclerc

Dijon, France

Location

Centre Hospitalier de la Dracénie

Draguignan, France

Location

Centre Hospitalier de Bretagne Sud

Lorient, France

Location

Centre Léon Bérard

Lyon, France

Location

Hôpital de la Timone

Marseille, France

Location

Centre Henri Becquerel

Rouen, France

Location

Hôpital Foch

Suresnes, France

Location

CHU Bretonneau

Tours, France

Location

Institut Gustave Roussy

Villejuif, France

Location

Related Publications (1)

• Guigay J, Fayette J, Dillies AF, Sire C, Kerger JN, Tennevet I, Machiels JP, Zanetta S, Pointreau Y, Bozec Le Moal L, Henry S, Schilf A, Bourhis J. Cetuximab, docetaxel, and cisplatin as first-line treatment in patients with recurrent or metastatic head and neck squamous cell carcinoma: a multicenter, phase II GORTEC study. Ann Oncol. 2015 Sep;26(9):1941-1947. doi: 10.1093/annonc/mdv268. Epub 2015 Jun 24.

  PMID: 26109631 DERIVED

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Recurrence; Neoplasm Metastasis

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplastic Processes

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: Pr. Joël GUIGAY
• Organization: Centre Antoine Lacassagne

joel.guigay@nice.unicancer.fr

+33492031000

Study Officials

• Joel GUIGAY

  GORTEC

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2011
• First Posted: February 3, 2011
• Study Start: September 1, 2009
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: May 15, 2017
• Results First Posted: April 7, 2017

Record last verified: 2016-10

Locations

BE (3); FR (11)