An Open-labeled, Randomized, Parallel Group Trial of zalutumumab, a Human Monoclonal Anti-EGF receptor Antibody, in combination with Best Supportive Care, versus 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: 8.1Level: LLTClassification code 10060121Term: Squamous cell carcinoma of head and neck
- Registration Number
- EUCTR2006-002472-17-GB
- Lead Sponsor
- Genmab A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 273
1) Males and Females age = 18 years
2) 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.
3) 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, in combination with other chemotherapy agents (i.e.5-fluorouracil (5FU)) and/ or radiation.
Platinum-based chemotherapy may have been given as monotherapy, in combination with 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;
1) If a patient has obtained a response according to RECIST after standard platinum based chemotherapy the patient is eligible if a progression is confirmed within 6 months following standard platinum based chemotherapy.
Disease progression should be documented with:
•a scan/image acquired at response after standard platinum-based chemotherapy or a scan/image acquired before standard platinum based chemotherapy
and
•a scan/image acquired within 6 months after standard platinum based chemotherapy
2) If a patient has obtained no response after platinum based chemotherapy
Disease progression should be documented with
•a scan/image acquired before standard platinum based chemotherapy
and
•a scan/image acquired within 6 months after standard platinum based chemotherapy.
In both situations the scan taken at the screening visit for this trial may serve as the progression scan if it is performed within 6 months after standard platinum based chemotherapy.
4) Measurable disease defined as one or more target lesions according to RECIST.
5) WHO performance status = 2.
6) 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
1) Three or more prior chemotherapy regimens other than platinum based chemotherapy
2) Prior treatment with EGFr antibodies and/or EGFr small molecule inhibitors
3) Received the following treatments within 4 weeks prior to Visit 2:
? Cytotoxic or cytostatic anti-cancer chemotherapy
? Total tumor resection
4) Past or current malignancy other than SCCHN, except for:
? Cervical carcinoma Stage 1B or less
? 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
5) 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.
6) Known brain metastasis or leptomeningeal disease.
7) 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.
8) 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.
9) Expected survival < 3 months.
10) Known HIV positive
11) Known hepatitis B and/or C
12) Screening laboratory values:
? WBC < 3.0 x10E9/L
? Neutrophils < 1.5 x10E9/L
? Platelets < 75 x10E9/L
? ALAT > 2.5 times the upper limit of normal (unless known liver metastases)
? ALP > 2.5 times the upper limit of normal (unless known bone metastases)
? Bilirubin > 1.5 times the upper limit of normal
? Creatinine > 1.5 the upper limit of normal.
13) Patients who have received treatment with any non-marketed drug substance within 4 weeks prior to Visit 1 (screening)
14) Current participation in any other interventional clinical study
15) Patients known or suspected of not being able to comply with this trial protocol
16) Breast feeding women or women with a positive pregnancy test at Visit 1.
17) Women of childbearing potential not willing to use adequate contraception as hormonal birth control or intrauterine device, during study and 12 months after last dose of HuMax-EGFr.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To investigate if HuMax-EGFr in combination with Best Supportive Care (BSC) is superior to BSC in terms of overall survival in non-curable patients with recurrent and/or metastatic disease who have failed at least one course of standard platinum-based chemotherapy;Secondary Objective: To compare HuMax-EGFr in combination with BSC to BSC with respect to efficacy, safety and Quality of Life (QoL) and to determine the pharmacokinetic profile of HuMax-EGFr;Primary end point(s): Overall Survival (OS) defined as the time from randomization until date of death from any cause.
- Secondary Outcome Measures
Name Time Method