An Open label single arm trial investigating zalutumumab, a Human Monoclonal Anti-EGF receptor Antibody, in combination with Best supportive Care, in Patients with Non-Curable Squamous Cell Carcinoma of the Head and Neck who have failed Standard Platinum-based Chemotherapy. - Zalutumumab in non-curable patients with SCCH

• Conditions: on-curable squamous cell carcinoma of the head and neck (SCCHN); MedDRA version: 9.1Level: LLTClassification code 10060121Term: Squamous cell carcinoma of head and neck

• Registration Number: EUCTR2008-000582-39-IT
• Lead Sponsor: GENMAB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12-22
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Males and females age ≥18 years (≥19 years of age in countries where patients are required to be so for adult participation in a clinical trial).
Histologically or cytologically confirmed diagnosis, initially or at relapse, of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx, considered incurable with standard therapy.
Failure to at least one course of standard platinum-based chemotherapy.
One course of standard platinum-based chemotherapy is defined as at least two cycles of cisplatin (≥60 mg/m2/cycle) or carboplatin (≥250 mg/m2/cycle). The interval between the cycles should be less than or equal to 4 weeks.
For other dose-regimens a total accumulative dose of cisplatin ≥120 mg/m2 or carboplatin ≥500 mg/m2 given within a maximum of 8 weeks is acceptable (dose-intensity ≥15 mg/m2/week for cisplatin and ≥62 mg/m2/week for carboplatin).
Platinum-based chemotherapy may have been given as monotherapy, or in combination with other chemotherapy including fluorouracil (5-FU) and/or radiation.
Failure is defined as (a) refractory or (b) intolerant to a standard platinum-based chemotherapy as follows:
a. Refractory is defined as disease progression according to RECIST during one course of standard platinum-based chemotherapy or within 6 months after completion of one course of standard platinum-based chemotherapy, given as treatment of
non-metastatic disease when platinum-based chemotherapy was given with a curative intention
metastatic disease
relapse not amenable for curative intervention

b. Intolerant is defined as discontinuation of one course of platinum-based chemotherapy due to side effects/toxicity irrespective of response.
Patients must have disease progression according to RECIST, documented with two CT scans or MR images.
Measurable disease defined as one or more target lesions according to RECIST.

WHO performance status ≤ 2.

Following receipt of verbal and written information about the study, the patient must provide signed informed consent before any study related activity is carried out.
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

Exclusion Criteria

Three or more prior chemotherapeutic regimens, other than platinumbased chemotherapy.

Prior treatment with EGFr antibodies and/or anti EGFr small molecule inhibitors.

Received the following treatments within 4 weeks prior to administration of study drug (visit 2):
Cytotoxic or cytostatic anti-cancer chemotherapy
Total tumor resection.

Past or current malignancy other than SCCHN, except for:
Cervical carcinoma Stage 1B or less
Stage 1 or 2 treated prostate cancer with a prostate specific antigen (PSA) in the normal range for >2 years post treatment.
Non-invasive basal cell and squamous cell skin carcinoma
Malignant melanoma with a complete response of a duration of > 10 years
Other cancer diagnoses with a complete response of a duration of > 5 years.

Chronic or current infectious disease such as, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis, sinusitis, and tuberculosis. Exempted are secondary infections in tumor lesions.
Known brain metastasis or leptomeningeal disease.
Clinically significant cardiac disease including unstable angina, acute myocardial infarction within six months from Visit 1, congestive heart failure, and arrhythmia requiring therapy, with the exception of extra systoles or minor conduction abnormalities.
Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease evaluated by the investigator to interfere with effect of the study drug.
Expected survival < 3 months.
Known HIV positive.
Known hepatitis B and/or C.
Screening laboratory values:
oNeutrophils < 1.5 x109/L
oPlatelets < 75 x109/L
oALAT > 2.5 times the upper limit of normal (unless known liver metastases)
oALP > 2.5 times the upper limit of normal (unless known bone metastases)
oBilirubin > 1.5 times the upper limit of normal
oCalculated creatinine clearance >50 mL/min.

Current participation in any other interventional clinical study.

Patients known or suspected of not being able to comply with this trial protocol.

Breast feeding women or women with a positive pregnancy test at Visit 1.
Women of childbearing potential not willing to use adequate contraception as hormonal birth control, intrauterine device or double barrier method, during study and 12 months after last dose of zalutumumab.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate zalutumumab in combination with BSC in terms of overall survival in non-curable patients with recurrent and/or metastatic disease who have failed after at least one course of standard-based chemotherapy.;Secondary Objective: To investigate zalutumumab in combination with BSC with respect to efficacy, safety, and Quality of Life (QoL) and to determine the pharmacokinetic profile of zalutumumab;Primary end point(s): Overall Survival (OS) defined as the time from start of treatment until date of death from any cause.