A Dose-Escalation, Randomized Phase I/II trial of Zalutumumab - a Human Monoclonal Anti-EGF receptor Antibody - With or Without Irinotecan chemotherapy in Cetuximab refractory Colorectal Cancer patients Who Have Failed Standard Chemotherapy and Progressed During or Within 6 months of Stopping Cetuximab-Based Therapy. - Zalutumumab with or without Irinotecan Chemotherapy in Cetuximab-Refractory Colorectal Cancer

• Conditions: Refractory Colorectal Cancer; MedDRA version: 9.1Level: LLTClassification code 10061451Term: Colorectal cancer

• Registration Number: EUCTR2007-005690-59-BE
• Lead Sponsor: Genmab A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11-23
• Last Update Posted: 7 October 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 97

Inclusion Criteria

1.Males and Females age = 18 years.
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.
3.Histologically or cytologically confirmed diagnosis of CRC.
4.Documented disease progression (verified by CT scan and/or MRI according to RECIST) during or within 6 months of finishing cetuximab-based therapy
•These images can be used as baseline for this protocol provided they were taken no more than 3 weeks prior to randomization
5.The cumulative dose of cetuximab must be = 1000mg/m2
6.Failure and/or intolerance to standard chemotherapy
7.Measurable disease defined as one or more target lesions according to RECIST.
8.WHO performance status = 2.
9.Absence of KRAS mutation in the tumor specimen.

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

1.Prior treatment with anti-EGFR antibodies other than cetuximab
2.Received the following treatments within 4 weeks prior to Visit 2:
-Cytotoxic or cytostatic anti-cancer chemotherapy
-Total resection or irradiation of the target lesion
- Any investigational agent
3.Diarrhea CTCAE > 1
4.Skin rash CTCAE > 1
5.Intolerance to irinotecan
6.Past or current malignancy other than CRC, 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 considered in remission for > 5 years
7.Chronic or current infectious disease
8.Known brain metastasis or leptomeningeal disease.
9.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
10.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 interfere with effect of the study drug
11.Expected survival < 3 months.
12.Known HIV positive
13.Known active hepatitis B and/or C
14.Screening laboratory values:
-WBC < 3.0 x109/L
-Neutrophils < 1.5 x109/L
-Platelets < 75 x109/L
-ALAT > 5 times the upper limit of normal
-ALP > 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.
15.Current participation in any other interventional clinical study
16.Patients known or suspected of not being able to comply with this trial protocol
17.Breast feeding women or women with a positive pregnancy test at Visit 1.
18.Male not willing to use adequate contraception during and 12 months after last dose of zalutumumab or 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 zalutumumab.
19.Patients with known uncontrolled allergic conditions or allergy to the study drugs and/or their components.

Study & Design

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