Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck MedDRA version: 13.1 Level: PT Classification code 10063569 Term: Metastatic squamous cell carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Alimta
Pharmaceutical Form: Powder for infusion
INN or Proposed INN: PEMETREXED DISODIUM
CAS Number: 150399-23-8
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration
Sponsors
Eli Lilly and Company Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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 [2] Prior therapies: o Radiation therapy must be completed at least 4 weeks before study enrollment (first dose of study therapy). For palliative therapy, prior radiation therapy allowed to =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion 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. [18] Have serious cardiac disease, such as symptomatic angina [NYHA grade III and IV], unstable angina, or the history of myocardial infarction in the previous 12 months. [19] Second primary malignancy that is clinically detectable at the time of consideration for study enrollment. [20] Have had another primary malignancy other than HNC, unless that prior malignancy was treated at least 2 years previously with no evidence of recurrence. Exception: Patients with a history of in situ carcinoma of the cervix, nonmelanoma skin cancer, or low-grade (Gleason score = 6) localized prostate cancer will be eligible even if diagnosed and treated less than 2 years previously. [21] Nasopharyngeal, paranasal sinus, lip, or salivary gland cancer. [22] Presence of clinically significant (by physical exam) third-space fluid collections; for example, ascites or pleural effusions that cannot be controlled by drainage or other procedures prior to study entry. [23] Have peripheral neuropathy of Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or higher. [24] Have central nervous system (CNS) metastases (unless the patient has completed successful local therapy for CNS metastases and has been off corticosteroids for at least 4 weeks before starting study therapy). Brain imaging is required in symptomatic patients to rule out brain metastases, but is not required in asymptomatic patients. [25] Inability to interrupt aspirin or other nonsteroidal anti-inflammatory agents, other than an aspirin dose = 1.3 grams per day, for a 5-day period (8-day period for long-acting agents, such as piroxicam). [26] Unable or unwilling to take folic acid, vitamin B12, or prophylactic corticosteroids. [27] Recent (within 30 days before enrollment) or concurrent yellow fever vaccination. [28] Pregnant or breast-feeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 physician-assessed 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 | — |
Countries
Belgium, Germany, Italy, Spain, United Kingdom
Outcome results
None listed