Intra-hepatic and systemic chemotherapy with or without antibody for patients with non-resectable liver metastasis from solid tumours

Phase 1

• Conditions: Intra-hepatic and systemic chemotherapy with or without antibody for patients with non-resectable liver metastasis from solid tumours; MedDRA version: 13.1Level: LLTClassification code 10007095Term: Cancer of liver, secondarySystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

• Registration Number: EUCTR2011-000273-31-DK
• Lead Sponsor: Herlev University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05-13
• Last Update Posted: 24 July 2017

Recruitment & Eligibility

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

Inclusion Criteria

•Informed consent
•Age > 18 years
•Performance status 0-1; expected survival = 3 months
•Patient with histologically verified malignity
•Liver metastases not suitable for surgery or other local treatment
•Present of liver metastases must be documented by CT/PET-CT-scan. Extrahepatic disease should be excluded except for patients with colorectal cancer. In patients with colorectal cancer the patients must have limited extrahepatic disease if the extrahepatic disease is stable in four month or potentially resectable.
•Measurable disease (RECIST 1.1)
•Metastases < 70 % of the liver
•Neutrofile granulocytes ? 1.5 x 109/l and thrombocytes ? 100 x 109/l
•Bilirubine ? 2.0 x UNL (upper normal limit).
•Creatinine-clearence ? 30 ml/min.
•INR < 1.6
•Intrahepatic treatment can be accomplished

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

•Other current or prior malignant disease in the past five years, except adequately treated and cured carcinoma in situ of the cervix or squamous cell carcinoma of the skin.
•Cytotoxic or experimental treatment within a 14 days period before start of trial medication
•The patient is not allowed to participate in other clinical trials.
•Other severe medical conditions
•Severe cardial disease or AMI < 1 year
•Presence of diseases preventing oral therapy
•Patients with uncontrolled infection
•Pregnant or lactating women
•Women capable of childbearing not using a sufficient method of birth control
•Patients not able to understand the treatment or to collaborate
•Prior serious or unsuspected reaction after treatment with fluorpyrimidin
•Known prior hypersensitivity reactions to the agents
•Interstitial pneumonitis or pulmonary fibrosis

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: Tumour response (RECIST version 1.1)<br><br>;Secondary Objective: Time to<br>a) Time to progression <br>b) Number of patients with a response that make them suitable for local therapy (radiofrequency, microwave destruction, surgery) <br>c) Survival <br>d) Toxicity<br> <br>Correlation between biomarkers in tissue and blood (e.g. genes: mRNA and microRNA, SNP array profiles; proteins: p53, P1NP, P3NP, TIMP-1, IL-6, YKL-40, EGFR and VEGF and metabolittes and clinical endpoints (response, time to progression, survival)<br><br>;Primary end point(s): Tumour response (RECIST version 1.1)