Clinical trial NCT00971932: Study of Cetuximab in Combination With Chemotherapy in Patients With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Official title: Open-label, Single-arm, Multicenter, Phase II Study Investigating Cetuximab in Combination With Chemotherapy in the First-line Treatment of Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN) in Japanese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Squamous Cell Carcinoma of the Head and Neck
Keywords: Recurrent and/or metastatic
SCCHN
Lead sponsor: Merck KGaA, Darmstadt, Germany
Sponsor class: INDUSTRY
First posted: 2009-09-04
Enrollment: 33
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this trial is to assess the antitumor activity of cetuximab when given in combination with cisplatin + 5-Fluorouracil (5-FU) for the first-line treatment of recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN) in Japanese subjects.


Eligibility criteria: Inclusion Criteria:

1. Histologically or cytologically confirmed diagnosis of SCCHN
2. Confirmed epidermal growth factor receptor (EGFR) expression in tumor tissue by immunohistochemistry (IHC)
3. Expected survival is more than 6 months
4. Presence of at least 1 bidimensionally measurable lesion either by computed tomography (CT) scan or magnetic resonance imaging (MRI)
5. Recurrent and/or metastatic SCCHN not suitable for local therapy
6. Greater than or equal to (\>=) 20 years of age
7. Karnofsky performance status (KPS) \>= 70% at trial entry
8. Neutrophils: \>= 1500 per millimeter\^3 (1,500/mm\^3); platelet count \>= 100,000/mm\^3; and hemoglobin \>= 9 gram per deciliter (g/dL)
9. Total bilirubin less than or equal to (\<=) 2 \* upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \<= 3 \* ULN
10. Creatinine clearance \>60 milliliter per minute (mL/min).Calculated based on formulae such as the Cockroft-Gault formula for creatinine clearance
11. Serum calcium within normal range (If serum albumin \< 4.0 g/dL, the following adjusted serum calcium concentration should be within normality: Adjusted serum calcium concentration = actual serum calcium (milligram per deciliter \[mg/dL\]) - 0.8 \* \[actual serum albumin (g/dL) - 4\]
12. Effective contraception if risk of conception exists (applicable for both male and female subjects)
13. Signed written informed consent
14. Japanese (with Japanese citizenship)

Exclusion Criteria:

1. Nasopharyngeal carcinoma
2. Prior systemic chemotherapy, except if given as part of a multimodal treatment, which was completed more than 6 months prior to trial entry
3. Surgery (excluding prior diagnostic biopsy) or irradiation within 4 weeks before trial entry
4. Pregnancy (absence to be confirmed by serum/urine human chorionic gonadotropin \[HCG\] test) or breastfeeding
5. Known hypersensitivity or allergic reaction against any of the components of the trial treatment including excipients
6. Uncontrolled diabetes, malignant hypertension (defined as systolic blood pressure \>= 180 millimeter of mercury \[mmHg\] and/or diastolic blood pressure \>= 130 mmHg under resting conditions) or liver failure
7. Pulmonary fibrosis, acute lung injury or interstitial pneumonia, or with previous medical history of these states
8. Active infection, (infection requiring IV antibiotics, antibacterial, antifungal, or antiviral agent), including active tuberculosis, or known and declared human immunodeficiency virus (HIV)
9. 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
10. Current other squamous cell carcinoma (SCC) or previous other malignancy (excluding skin cancer except for melanoma and carcinoma in situ of the cervix or digestive tract) within the last 5 years
11. Intake of any investigational medication within 30 days before trial entry
12. Other concomitant anticancer therapies
13. Documented or symptomatic brain or leptomeningeal metastasis
14. Medical or psychological condition that would not permit the subject to complete the trial or sign informed consent including known drug abuse
15. Previous treatment with monoclonal antibody therapy, other signal transduction inhibitors or EGFR targeting therapy
16. Legal incapacity or limited legal capacity
17. Other protocol-defined exclusion criteria may apply

Primary outcomes:
measure: Best Overall Response (BOR) According to Modified World Health Organization (WHO) Criteria
timeFrame: Evaluations performed every 6 weeks until progressive disease (PD) reported between day of first participant treated, until cut-off date, 02 March 2011
Secondary outcomes:
measure: Best Overall Response (BOR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Criteria
timeFrame: Evaluations performed every 6 weeks until PD reported between day of first participant treated, until cut-off date, 02 March 2011
measure: Disease Control Rate
timeFrame: Evaluations performed every 6 weeks until PD reported between day of first participant treated, until cut-off date, 02 March 2011
measure: Duration of Response
timeFrame: Time from first assessment of CR or PR to PD, death or last tumor assessment, reported between day of first participant treated, until cut-off date, 02 March 2011
measure: Progression-Free Survival (PFS) Time
timeFrame: Time from first administration of trial treatment to PD, death or last tumor assessment, reported between day of first participant treated, until cut-off date, 02 March 2011
measure: Overall Survival (OS) Time
timeFrame: Time from first administration of trial treatment or last day known to be alive, reported between day of first participant treated, until cut-off date, 02 March 2011
measure: Time to Treatment Failure
timeFrame: Time from first administration of trial treatment to treatment failure or last tumor assessment, reported between day of first participant treated, until cut-off date, 02 March 2011
Other outcomes:
Locations:
city: Aichi
country: Japan
facility: Research Site
city: Chiba
country: Japan
facility: National Cancer Center East Hospital
city: Ehime
country: Japan
facility: Research Site
city: Hokkaido
country: Japan
facility: Research Site
city: Kanagawa
country: Japan
facility: Research Site
city: Kanagawa
country: Japan
facility: Tokai University
city: Osaka
country: Japan
facility: Research Site
city: Shizuoka
country: Japan
facility: Research Site
city: Tochigi
country: Japan
facility: Research Site
city: Tokyo
country: Japan
facility: Research Site
Study officials:
affiliation: Merck Serono Co., Ltd., Japan
name: Mark P. Smith, MD
role: STUDY_DIRECTOR
References:
citation: Yoshino T, Hasegawa Y, Takahashi S, Monden N, Homma A, Okami K, Onozawa Y, Fujii M, Taguchi T, de Blas B, Beier F, Tahara M. Platinum-based chemotherapy plus cetuximab for the first-line treatment of Japanese patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck: results of a phase II trial. Jpn J Clin Oncol. 2013 May;43(5):524-31. doi: 10.1093/jjco/hyt034. Epub 2013 Mar 10.