Phase 2 Study of Pemetrexed in Combination with Cisplatin and Cetuximab in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck - ND
- Conditions
- Recurrent or Metastatic Squamous Cell Carcinoma of the Head and NeckMedDRA version: 9.1Level: LLTClassification code 10063569
- Registration Number
- EUCTR2009-011611-21-IT
- Lead Sponsor
- Eli Lilly and Company Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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;Primary end point(s): Progression Free Survival
- Secondary Outcome Measures
Name Time Method