Status:
COMPLETED
A Trial to Determine the Safety and Anti-tumor Activity Profile of the Combination of Cetuximab and Concomitant Cisplatin Plus 5-Fluorouracil (5-FU) in Subjects With Recurrent and/or Metastatic Squamous Cell Carcinoma in Head and Neck
Lead Sponsor:
Merck KGaA, Darmstadt, Germany
Conditions:
Squamous Cell Carcinoma of the Head and Neck
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The primary objective of this trial is to assess the antitumor activity and safety profile of cetuximab when given in combination with cisplatin + 5-Fluorouracil (5-FU) for the first-line treatment of...
Eligibility Criteria
Inclusion
- Signed written informed consent
- Inpatient
- Greater than or equal to (\>=) 18 years of age
- Histologically or cytologically confirmed diagnosis of SCCHN
- Recurrent and/or metastatic SCCHN not suitable for local therapy
- Presence of at least 1 measurable lesion identified either by computed tomography (CT) scan or magnetic resonance imaging (MRI) according to modified WHO criteria
- Karnofsky performance status (KPS) \>= 80 percent at trial entry
- Neutrophils \>= 1.5\*10\^9 per liter (L), platelet count \>= 100\*10\^9 per L, and hemoglobin \>= 90 gram per liter (g/L)
- Total bilirubin less than or equal to (\<=) 2\*upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \<=3\*ULN
- Serum creatinine \<=133 micromole per liter (mcmol/L)
- Serum calcium within normal range
- Effective contraception if procreative potential exists (applicable for both male and female subjects)
Exclusion
- Prior systemic chemotherapy, except if given as part of a multimodal treatment which was completed more than 6 months prior to trial entry
- Surgery (excluding prior diagnostic biopsy) or irradiation within 4 weeks before trial entry
- Nasopharyngeal carcinoma
- Active infection (infection requiring IV antibiotics), including active tuberculosis, or known and declared human immunodeficiency virus (HIV)
- Uncontrolled diabetes mellitus, pulmonary fibrosis, acute pulmonary disorder, interstitial pneumonia, cardiac failure or liver failure
- Uncontrolled hypertension defined as systolic blood pressure \>=180 millimeter of mercury (mmHg) and/or diastolic blood pressure \>=130 mmHg under resting conditions
- Pregnancy (absence to be confirmed by serum beta human chorionic gonadotrophin \[beta-HCG\] test) or breastfeeding
- Concomitant chronic systemic immune therapy or hormonal therapy as cancer therapy
- Other concomitant anticancer therapies
- Documented or symptomatic brain or leptomeningeal metastasis
- Clinically relevant coronary artery disease or history of myocardial infarction in the last 12 months or high risk of uncontrolled arrhythmia or uncontrolled cardiac insufficiency
- Medical or psychological condition that would not permit the subject to complete the trial or sign informed consent
- Known drug abuse (with the exception of alcohol abuse)
- Known hypersensitivity or allergic reaction against any of the components of the trial treatment
- Previous treatment with monoclonal antibody therapy, other signal transduction inhibitors or epidermal growth factor receptor (EGFR) targeting therapy
- Previous or current other squamous cell carcinoma (SCC)
- Evidence of previous other malignancy within the last 5 years
- Signs and symptoms suggestive of transmissible spongiform encephalopathy, or family members who suffer(ed) from such
- Intake of any investigational medication within 30 days before trial entry
- Legal incapacity or limited legal capacity
- Other significant disease that in the Investigator's opinion would exclude the subject from the trial
Key Trial Info
Start Date :
December 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT01177956
Start Date
December 1 2009
End Date
November 1 2012
Last Update
September 3 2014
Active Locations (14)
Enter a location and click search to find clinical trials sorted by distance.
1
Cancer Institute & Hospital, Chinese Academy of Medical Sciences
Beijing, China
2
Jilin Cancer Hospital
Changchun, China
3
The Xiangya 2nd Hospital of Central South University
Changsha, China
4
Fuijan Provincial Tumor Hospital
Fuijian, China