Phase 2 Study of Pemetrexed in Combination with Cisplatin and Cetuximab in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck - ND

Eli Lilly and Company Ltd.0 个研究点开始时间: 2010年4月7日最近更新: 2012年8月21日

适应症

试验速览

暂无简介。

•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.

发起方

Eli Lilly and Company Ltd.