Neoplasms

All Conditions

Symptoms and General Pathology

Wounds and Injuries

Blood and Lymph Conditions

Rare Diseases

Carcinoma

Hyperthermia

Neutropenia

Fever

Febrile Neutropenia

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Agranulocytosis

Leukopenia

Cytopenia

Hematologic Diseases

Leukocyte Disorders

Granulocytopenia

Antineoplastic Agents

All Drugs and Chemicals

Docetaxel

Fluorouracil

Cisplatin

ROLLAND Frederic, MD

The ending of this study is to describe the effect of febrile neutropenia on patients who receive a chemotherapy by docetaxel+cisplatin+fluorouracil(TPF).

In this study we will describe

* habits of medical staff in prescription of growth factors or antibiotic prophylaxis
* ratio of patients treated by growth factors in primary or secondary prophylaxis
* ratio of patients treated in primary prophylaxis who present a febrile neutropenia
* ratio of patients who need to be hospitalized and the duration of those hospitalizations.
* causes of lateness, of decreasing, and of stop of chemotherapy
* antibiotic and growth factors prophylaxis tolerance .

Hematologic Toxicity Observation of the Docetaxel+ Cisplatin+ Fluorouracil (TPF)Medical Protocol

Hematologic Toxicity Observation of the TPF Medical Protocol. Description of the Impact of Febrile Neutropenia in Patients Who Receive the Chemotherapy of the TPF Medical Protocol in Head and Neck Cell Carcinoma

evaluation of medical status evaluation of hematologic toxicity description of clinic toxicity: fever, sepsis..

Groupe Oncologie Radiotherapie Tete et Cou

Carcinoma, Squamous Cell

Neoplasm Metastasis

Recurrence

Head and Neck Neoplasms

Squamous Cell Carcinoma of Head and Neck

Disease Attributes

Neoplastic Processes

Cetuximab

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

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.

Overall Study

Carboplatin

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Radiotherapy : 70 grays , fractionization : 2Gy/day, 5 days / week, for 7 weeks . Concurrent administration of Carboplatin: 70 mg/m2/day (day 1 until day 4)and 5FU 600 mg/m2/day (day 1 until day 4). Weeks 1; 4; 7.

Induction chemotherapy by Docetaxel 100mg/m2, day 1; cisplatin 100mg/m2, day 1; 5-Fluorouracil 1000mg/m2 (from day 1 to day 5), for a total of three cycles .Those cycles are administrated at day 1; day 22, day43.

This induction chemotherapy is followed ( for responders or stable disease patients)by radiotherapy (70 grays for 7 weeks) and concurrent Erbitux( weekly administration).

70 mg per m2 and per day for four days. day 1; day 22; day 43

carboplatin

600mg per m2 per day for four days. 3 cycles day 1; day 22; day 43

5 fluorouracil

total dose: 70 grays. The patient receives 2 grays per day; five days a week during 7 weeks

radiation therapy

Lionnel GEOFFROIS, oncologist

Etienne BARDET, oncologist

Christian SIRE, oncologist

Laurent MARTIN, oncologist

Jean-Marc TOURANI, oncologist

Philippe MAINGON, oncologist

Ayman ZAWADI, oncologist

François GUICHARD, oncologist

Anne-Françoise DILLIES, oncologist

Dominique De RAUCOURT, oncologist

Emmanuel BABIN, oncologist

Claude TUCHAIS, oncologist

XU SHAN Sun, oncologist

Nicolas MEERT, oncologist

Anne-Rose HENRY, oncologist

Cedrik LAFOND, oncologist

Thierry PIGNON, oncologist

Ali HASBINI, oncologist

Jean BOURHIS, oncologist

Marie SALIOU, oncologist

Alexandre COUTTE, oncologist

The purpose of this study is to demonstrate that induction chemotherapy followed by radiation therapy plus Cetuximab will give better results than the validated treatment (chemoradiotherapy), for treatment of locoregional advanced head and neck cancers.

Concurrent chemoradiotherapy (radiotherapy+ carboplatin + 5FU) is a validated treatment for patients with locoregional advanced head and neck cancers.

This study evaluates the outcome of induction chemotherapy (docetaxel, cisplatin, 5 FU) followed by radiation therapy + Erbitux for patients with head and neck carcinoma with almost one measurable lesion by RMI or CT scan.

We hope we can improve the progression free survival of 14% at two years .

Chemoradiotherapy HNSCC, Randomized Study, Docetaxel,Cisplatin, 5FU,Erbitux.

A Phase III Randomized Multicenter Study,Comparing an Induction Chemotherapy Followed by Irradiation and Concurrent Erbitux Versus Chemoradiotherapy for Patients With Locoregional Advanced Head and Neck Cancers

Sunitinib

Angiogenesis Inhibitors

Growth Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

patients will receive SU011248 in monotherapy

No intervention, only biopsy for translational project

biopsies

SU011248

Jean-Pascal H Machiels, MD PhD

Preclinical studies as well as phase I and II trials have demonstrated that SU11248 has antitumor activity in renal cell carcinoma, breast cancer, neuroendocrine tumor and GIST. So at the light of these pre-clinical and clinical data, it seems interesting and promising to test SU011248 in these poor prognosis patients.

This is an open-label phase II, multicenter study. Eligible patients will receive SU011248 in monotherapy (37.5 mg given continuously without interruption). Tumor check-up will be performed every 6-8 weeks. Treatment will be continued until disease progression or unacceptable toxicities according to the patient or the investigator (the median for treatment in renal cell study was 8 months).

Since, head and neck tumors are easily accessible for iterative biopsy, this study will offer the opportunity to get tumor biopsies before and after SU011248. Our study will allow translational research with biopsies at crucial timing: at baseline before any treatment, , during the treatment with SU011248 (cycle 1, between week 4 and 6), for patients with stable disease or partial response, a new biopsy will be performed at the time of disease progression to try to understand the mechanisms of tumor or resistance.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Hematologic Toxicity Observation of the Docetaxel+ Cisplatin+ Fluorouracil (TPF)Medical Protocol	NCT01268878	Squamous Cell H...		18 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
Chemoradiotherapy HNSCC, Randomized Study, Docetaxel,Cisplatin, 5FU,Erbitux.	NCT01233843	Squamous Cell H...	carboplatin 5 fluorouracil radiation thera...	18 Years - 70 Years	Groupe Oncologie Radiotherapie Tete et Cou
Efficacy of SU 011248 in Head And Neck Carcinoma	NCT00408252	Recurrent Disea... Squamous Cell H... Palliative Trea...	biopsies SU011248	18 Years -	Cliniques universitaires Saint-Luc- Université Catholique de Louvain
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

Spots Global Cancer Trial Database for squamous cell head and neck carcinoma