Intra-hepatic Chemotherapy in Patients With Liver Metastases From Breast Cancer and Limited Extrahepatic Disease

Launched by DORTE NIELSEN · Jun 30, 2011

Keywords

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Gender

ALL

Eligibility criteria

• • Inclusion Criteria:• Informed consent
• • Age \> 18 years
• • Performance status 0-1; expected survival ≥ 3 months
• • Patient with histologically or cytologically confirmed locally advanced or metastatic adenocarcinoma of the breast
• • Liver metastases not suitable for local treatment
• • Extrahepatic disease should be determined by PET-CT-scan.
• • No progression on treatment with capecitabine.
• • Prior treatment with taxane (adjuvant or for metastatic disease)
• • Metastases \< 70 % of the liver
• • Neutrophile granulocytes \> 1.5 x 109/l og thrombocytes \> 100 x 109/l
• • Bilirubin \< 2.0 x UNL (upper normal limit).
• • Creatinine-clearance \> 30 ml/min.
• • INR \< 1.6.
• • If the patient is HER2-positive:Baseline LVEF ≥ 50 %
• Exclusion Criteria:
• • History of chemotherapy within the 4-week period prior to the start of trial medication
• • Other current or prior malignant disease except adequately treated and cured carcinoma in situ of the cervix or squamous cell carcinoma of the skin.
• • Previous treatment with oxaliplatin
• • 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.
• • Any clinical symptoms suggesting peripheral neuropathy \< or equal to grade 2 or CNS metastases (In case of clinical suspicion on CNS metastases a MR or CT scan should be performed within 4 weeks before inclusion
• • Other severe medical conditions e.g. severe cardial disease or AMI \< 1 year
• • Presence of diseases which prevent oral therapy.
• • Patients with uncontrolled infection
• • Pregnant or lactating women
• • Women capable of childbearing not using a sufficient non-hormonal method of birth control
• • Patients not able to understand the treatment or to collaborate.
• • Prior serious or unsuspected reaction after treatment with fluoropyrimidine
• • Known prior hypersensitivity reactions to the agents
• If the patient is HER2-positive:
• • Dyspnoea in due to complication related to malignant disease e.g.lung metastases with lymphangitis or other conditions with need of supportive oxygen.