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Register:	EUCTR
Last refreshed on:	21 August 2012
Main ID:	EUCTR2009-011611-21-IT
Date of registration:	07/04/2010
Prospective Registration:	Yes
Primary sponsor:	Eli Lilly and Company Ltd.
Public title:	Phase 2 Study of Pemetrexed in Combination with Cisplatin and Cetuximab in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck - ND
Scientific title:	Phase 2 Study of Pemetrexed in Combination with Cisplatin and Cetuximab in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck - ND
Date of first enrolment:	08/04/2010
Target sample size:
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-011611-21
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: Placebo: Other:
Phase:

Countries of recruitment
Belgium	Germany	Italy	Spain	United Kingdom

Contacts

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Key inclusion & exclusion criteria

Inclusion criteria:
8.1. Inclusion Criteria Patients are eligible to be included in the study only if they meet all of the following criteria: [1] Histologically confirmed diagnosis of squamous cell carcinoma of head and neck (SCCHN) o Recurrent or metastatic SCCHN, not amenable to local therapy o At least 6 months since completion of systemic therapy (chemotherapy or biological anticancer therapy) o No more than 1 prior systemic therapy, given as part of multimodal treatment for locally advanced disease; induction chemotherapy and subsequent concurrent chemoradiation are considered as 1 regimen o No prior systemic therapy for metastatic disease
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Patients will be excluded from the study if they meet any of the following criteria: [12] Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry. [13] Previously received treatment with monoclonal antibody therapy, or other signal transduction inhibitors of EGFR-targeting therapy. [14] Are receiving concurrent chronic systemic immune therapy, or chemotherapy for a disease other than cancer. [15] Concurrent administration of any other antitumor therapy. [16] Known prior allergic/hypersensitivity reaction to any of the components of the study treatment. [17] Serious concomitant systemic disorder (for example, active infection) or psychiatric disorder that, in the opinion of the investigator, would compromise the patient s ability to complete the study.

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
MedDRA version: 9.1 Level: LLT Classification code 10063569

Intervention(s)

Trade Name: ALIMTA
Pharmaceutical Form: Powder for infusion*
INN or Proposed INN: Pemetrexed
Concentration unit: mg/m2 milligram(s)/square meter
Concentration type: equal
Concentration number: 500-

Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Cisplatin
Concentration unit: mg/m2 milligram(s)/square meter
Concentration type: equal
Concentration number: 75-

Trade Name: ERBITUX
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Cetuximab
Concentration unit: mg/m2 milligram(s)/square meter
Concentration type: equal
Concentration number: 900-

Primary Outcome(s)

Primary end point(s): Progression Free Survival

Main Objective: The primary objective is to estimate the progression-free survival (PFS) for the combination of pemetrexed plus cisplatin plus cetuximab followed by optional pemetrexed plus cetuximab maintenance therapy.

Secondary Objective: The secondary objectives of the study are: To estimate overall survival (OS). To estimate the overall objective response rates (ORR) according to the Response Evaluation Criteria in Solid Tumors (RECIST; Therasse et al. 2000). To examine the safety and toxicity profile of study treatment. To assess health status using patient-reported EQ-5D and physicianassessed head and neck cancer (HNC) symptoms. To assess biomarkers relevant to the safety, efficacy, and mechanism of action of pemetrexed, cetuximab, and cisplatin. To assess the association between biomarkers and clinical outcome

Secondary Outcome(s)

Secondary ID(s)

H3E-MC-S123

2009-011611-21-BE

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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