Neoplasms

All Conditions

Symptoms and General Pathology

Carcinoma

Carcinoma, Squamous Cell

Neoplasm Metastasis

Recurrence

Head and Neck Neoplasms

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Disease Attributes

Neoplastic Processes

Antineoplastic Agents

All Drugs and Chemicals

Docetaxel

Cetuximab

Cisplatin

Lenograstim

Antineoplastic Agents, Immunological

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 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 IV

No intervention, only biopsy for translational project.

Biopsies

Joel GUIGAY

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.

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.

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

Phase II Study of Cetuximab, Docetaxel and Cisplatin as First-line Treatment in Patients With Metastatic or Recurrent Head and Neck Squamous Cell Carcinomas - GORTEC 2008-03 TPEx

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.

All grade 1 to 5 toxicity are registered during treatment. Patients have weekly clinical and biological examination.

Tumor response 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 MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions, Stable Disease (SD); Best overall Response = CR + PR + SD.

Gustave Roussy, Cancer Campus, Grand Paris

Groupe Oncologie Radiotherapie Tete et Cou

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: - 400 mg/m² over 120 minutes on day 1 of cycle 1 only.

* 250 mg/m² IV over 60 minutes weekly on subsequent administrations during the four cycles of chemotherapy.
* 500mg/m2 IV every 2 weeks during the maintenance therapy.

Drug: Cisplatin IV : 75 mg/m2 every 3 weeks for 4 cycles Drug: Docetaxel IV : 75 mg/m2 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.

Age, Categorical

Age, Continuous

Sex: Female, Male

Belgium

France

Region of Enrollment

Pr. Joël GUIGAY

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: - 400 mg/m² over 120 minutes on day 1 of cycle 1 only.

* 250 mg/m² IV over 60 minutes weekly on subsequent administrations during the four cycles of chemotherapy.
* 500mg/m² IV every 2 weeks during the maintenance therapy. Drug: Cisplatin IV : 75 mg/m² every 3 weeks for 4 cycles Drug: Docetaxel IV : 75 mg/m² 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.

Objective Tumor Response Rate

Grade 1 to 5 Toxicity

2 patients not assessable for response at 12 weeks

Best Overall Response

Progression-free Survival

Overall Survival

Biomarkers

cetuximab IV: - 400 mg/m² over 120 minutes on day 1 of cycle 1 only.

* 250 mg/m² over 60 minutes weekly on subsequent administrations
* 500mg/m2 every 2 weeks during the maintenance therapy. Drug: -Cisplatin IV : 75 mg/m2 every 3 weeks for 4 cycles
* Docetaxel IV : 75 mg/m2 every 3 weeks for 4 cycles G-CSF support mandatory after each cycle of chemotherapy. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. After completion of the 4th cycle of chemotherapy, patients receive a maintenance therapy with cetuximab every 2 weeks.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Chemotherapy With Cetuximab in Treating Patients With Recurrent or Metastatic Head and Neck Cancer	NCT01289522	Squamous Cell H... Recurrent or Me...	cetuximab IV Biopsies	18 Years - 70 Years	Groupe Oncologie Radiotherapie Tete et Cou
Chemotherapy With Cetuximab in Treating Patients With Recurrent or Metastatic Head and Neck Cancer	NCT01289522	Squamous Cell H... Recurrent or Me...	cetuximab IV Biopsies	18 Years - 70 Years	Groupe Oncologie Radiotherapie Tete et Cou

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