Intra-hepatic Chemotherapy With Oxaliplatin Every Second Week in Combination With Systemic Capecitabine in Patient With Non-resectable Liver Metastases From Breast Cancer A Phase II Trial in Patients With Limited Extrahepatic Disease
• 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 %
- History of chemotherapy within the 4-week period prior to the start of trial
- 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
- 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
- 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.