A Single Arm Multicentre Phase II Study of Panitumumab in Combination with Irinotecan/5-Fluorouracil/Leucovorin in Patients with Metastatic Colorectal Cancer

• Conditions: Patients with metastatic colorectal cancer; MedDRA version: 9.1Level: LLTClassification code 10052362Term: Metastatic colorectal cancer

• Registration Number: EUCTR2006-006739-36-BE
• Lead Sponsor: Amgen Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04-08
• Last Update Posted: 7 October 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Patients will be eligible to participate in the study if they meet all of the criteria listed below.
1. Ethical
Competent to comprehend, sign, and date an IEC-approved informed consent form.

2. Demographic
Of either gender and aged 18 years or more.

3. Disease-related
•Diagnosed with histologically- or cytologically-confirmed metastatic adenocarcinoma of the colon and/or rectum.
•Measurable disease according to modified RECIST guidelines. All sites of disease must have been evaluated within 28 days of initiating study treatment, and diagnosed by the investigator.
•Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
•Have available paraffin-embedded tissue or unstained tumour slides from primary or metastatic tumour.

4. Laboratory
-Haematologic function, as follows (within seven days prior to initiating study treatment):
• Absolute neutrophil count (ANC) = 1.5 x 109/L.
• Platelet count =100 x 109/L.
• Haemoglobin =10 g/dL.

-Renal function, as follows (within seven days prior to initiating study treatment):
• Creatinine =1.5 mg/dL.

-Hepatic function, as follows (within seven days prior to initiating study treatment):
• Aspartate aminotransferase (AST) =3 x ULN (if liver metastases = 5 x ULN).
• Alanine aminotransferase (ALT) =3 x ULN (if liver metastases = 5 x ULN).
• Bilirubin = 2 x ULN.

-Metabolic function, as follows (within seven days prior to initiating study treatment):
• Magnesium = lower limit of normal.
• Calcium = lower limit of normal.
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

Any patient exhibiting any of the criteria listed below will be excluded from the study:
1. Disease Related
• Central nervous system metastases (Exception: subjects who have been treated, have asymptomatic central nervous system metastases, and have been off steroids for at least 30 days before initiating study treatment are eligible).

2. Therapies
• Prior systemic therapy for the treatment of metastatic colorectal carcinoma with the exception of adjuvant fluoropyrimidine-based chemotherapy given at least six months prior to initiating study treatment.

• Prior anti-EGFr antibody therapy (e.g.: cetuximab) or treatment with small molecule EGFr tyrosine kinase inhibitors (e.g.: erlotinib).

• Prior radiotherapy within 14 days prior to screening, and for which all signs of early radiological toxicity have not abated.

3. General
• Significant cardiovascular disease including unstable angina or myocardial infarction within six months before initiating study treatment or a history of ventricular arrhythmia.

• History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on baseline chest CT scan.

• Treatment for systemic infection within 14 days before initiating study treatment.

• Active inflammatory bowel disease or other bowel disease causing chronic diarrhoea (defined as > 4 loose stools per day).

• History of Gilbert’s syndrome or dihydropyrimidine deficiency.

• History of any medical condition that may increase the risks associated with study participation or may interfere with the interpretation of the study results.

• Known positive test for human immunodeficiency virus infection, hepatitis C virus, chronic active hepatitis B infection.

• Any co-morbid disease that would increase risk of toxicity.

• Any kind of disorder that compromises the ability of the subject to give written informed consent and/or comply with the study procedures.

• Any investigational agent within 30 days before initiation of study treatment.

• Must not have had a major surgical procedure within 28 days prior to initiation of study treatment.

• Subject who is pregnant or breast-feeding.

• Woman or man of childbearing potential not consenting to use adequate contraceptive precautions i.e. double barrier contraceptive methods (e.g. diaphragm plus condom) during the course of the study and for six months after the last study drug administration for women, and one month for men.

• Subject unwilling or unable to comply with study requirements.

Study & Design

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