Know Cancer

or
forgot password

Open-label, Single-arm, Multicenter, Phase III Trial to Assess the Antitumor Activity and Safety Profile of Cetuximab When Given in Combination With Chemotherapy for the First-line Treatment of Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck in Asian Subjects


Phase 3
18 Years
N/A
Not Enrolling
Both
Squamous Cell Carcinoma of the Head and Neck

Thank you

Trial Information

Open-label, Single-arm, Multicenter, Phase III Trial to Assess the Antitumor Activity and Safety Profile of Cetuximab When Given in Combination With Chemotherapy for the First-line Treatment of Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck in Asian Subjects


Inclusion Criteria:



- 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 World Health
Organization (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 (<=)*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 Criteria:

- 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Best Overall Response (BOR)

Outcome Description:

BOR: Percentage of participants experiencing a Complete Response (CR) (complete disappearance of measurable and evaluable disease without new lesions) or Partial Response (PR) (greater than or equal to 50 percent decrease of sum of product diameters of measurable disease, evaluable disease not worsening or progressing, no new lesions confirmed by a subsequent assessment no less than 28 days after criteria for response were first met) (based on modified World Health Organization [WHO] criteria), divided by the number of participants belonging to intention to treat (ITT) or safety population.

Outcome Time Frame:

Evaluations were performed every 6 weeks until progression, reported between day of first participant randomized, 25 December 2009, until cut-off date 25 January 2011

Safety Issue:

No

Authority:

China: Ministry of Health

Study ID:

EMR62241_055

NCT ID:

NCT01177956

Start Date:

December 2009

Completion Date:

September 2011

Related Keywords:

  • Squamous Cell Carcinoma of the Head and Neck
  • Recurrent and/or metastatic squamous cell carcinoma of the head and neck
  • 1st-line
  • Cetuximab
  • Chemotherapy
  • EMR 62241 -055
  • Merck KGaA
  • Recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN)
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms

Name

Location