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

• Status: Unknown status
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dorte Nielsen
• Treatments: Capecitabine; Oxaliplatin; Trastuzumab

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.