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Phase II Trial of Carboplatin, 5-FU and Cetuximab in Elderly Fit (no Frailty) Patients With Recurrent/Metastatic HNSCC

Information source: Groupe Oncologie Radiotherapie Tete et Cou
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Metastatic or Recurrent HNSCC

Intervention: Carbo, 5FU, Cetuximab (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Groupe Oncologie Radiotherapie Tete et Cou

Overall contact:
Herve LE CAER, MD, Email: herve.lecaer@ch-draguignan.fr

Summary

The aim of the trial is to evaluate the clinical benefit (efficacy, safety, preservation of autonomy) of cetuximab-carboplatin-5FU combination as first line treatment of recurrent or metastatic head and neck squamous cell carcinoma in patients over 70 years without frailty (after geriatric assessment).

Clinical Details

Official title: Phase II Multicenter Trial Evaluating First Line Carboplatin, 5-Fluorouracil and Cetuximab in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Cancer, Aged 70 and Over, Ranked as Fit (no Frailty) by Geriatric Assessment

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Objective response and acute toxicity

Secondary outcome:

Best objective tumor response

Overall survival

progression free survival

Duration of response under cetuximab maintenance therapy

Toxicity of cetuximab maintenance therapy

autonomy

Quality of life

Eligibility

Minimum age: 70 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Age greater than or equal to 70 years

- patient enrolled in ELAN-ONVOCAL study and evaluated as fit (harmonious aging) by

GERICO screening method for geriatric frailty

- life expectancy superior to 12 weeks

- creatinin clearance > ou equal to 50ml/mn calculated using Modification of Diet in

Renal Disease (MDRD) formula

- hematologic function : absolute neutrophil count > 1. 5 x 10^9/l, platelets > 100 x

10^9/l, hemoglobin > 9,5 g/dl

- liver function : total bilirubin inferior to 1,25 x Upper limit of normal (ULN),

SGOT/SGPT inferior to 5 x ULN, PAL inferior to 5 x ULN

- PS < 2

The disease:

- histologically proven head and neck squamous cell carcinomas

- recurrent or metastatic. Visceral metastases or locoregional recurrence unsuitable

for curative locoregional treatment: unsuitable for primitive tumor surgery due to local extension (evidently authorized for lymph nodes) and unsuitable for radiotherapy for primitive tumor (or already performed) due to metastatic dissemination and the absence of indication for re-irradiation of primitive tumor.

- Presence of at least one measurable lesion (defined by RECIST criteria) by CT scan or

IRM

- asymptomatic cerebral metastases authorized

General:

- signed Informed Consent Form

- affiliated to the French social security system (or a beneficiary of this system)

according to the provisions of the law of 9 August 2004 Exclusion Criteria:

- Previous systemic chemotherapy, except for chemotherapy as part of multimodal

treatment for locally advanced cancer completed more than 6 months prior to study enrollment

- Known contraindication specific to one of study treatments (particularly cardiac for

5FU)

- Known dihydropyrimidine dehydrogenase deficiency (DPD deficiency).

- Patients considered as "unfit " (fragile) by GERICO screening method for geriatric

frailty

- Irradiation within 4 weeks prior to study enrollment.

- Nasopharyngeal, rhinopharyngeal or maxillary sinus carcinoma.

- Presence of infection (infection requiring intravenous antibiotics), including

tuberculosis and HIV infection (human immunodeficiency virus).

- Concomitant treatment with other antitumor immunotherapy or hormonal therapy.

- Other antitumor concomitant therapies.

- Prior treatment with EGFR-targeted therapy (epidermal growth factor receptor).

- Treatment with one of study drugs within 30 days prior to study enrollment.

- Presence of documented symptomatic brain or leptomeningeal metastases

- Clinically significant coronaropathy or antecedent myocardial infarction within 12

months prior to study enrollment or high-risk uncontrolled arrhythmias or uncontrolled heart failure.

- Medically uncontrolled arterial hypertension

- Other prior or concomitant cancer, with exception for carcinoma in situ of the

uterine cervix, or for cutaneous basal cell carcinoma within 5 years prior to study enrollment.

- Presence of medical or physiological factors susceptible to modify patient compliance

with study protocol and follow-up or Informed Consent Form signing.

- Known allergy or hypersensibility to monoclonal antibodies (bevacizumab, cetuximab),

or to other chemotherapies of the study or to their excipients

Locations and Contacts

Herve LE CAER, MD, Email: herve.lecaer@ch-draguignan.fr

Hôpital de la Dracénie, Draguignan 83300, France; Not yet recruiting
Herve LE CAER, MD, Email: herve.lecaer@ch-draguignan.fr
Herve LE CAER, MD, Principal Investigator

Institut Gustave Roussy, Villejuif 94805, France; Recruiting
Joel GUIGAY, MD, PhD, Email: joel.guigay@igr.fr
Joel GUIGAY, MD,PhD, Principal Investigator

Additional Information

GORTEC

Starting date: June 2013
Last updated: March 23, 2015

Page last updated: August 20, 2015

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