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

MA 0918

This is a phase II trial evaluating intra-hepatic chemotherapy with oxaliplatin every second week in combination with systemic capecitabine and in patients with a HER2-positive tumour in combination with trastuzumab (Herceptin®) in patient with non-resectable liver metastases from breast cancer. Only patients with limited extrahepatic disease are included.

2010-04-01

2017-05-01

2017-09-01

Completed

Early phase I

38

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.

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2023-12-11