Intra-hepatic Chemotherapy in Patient With Non-resectable Liver Metastases From Breast Cancer

Dorte Nielsen

Status and phase

Completed

Phase 2

Conditions

Liver Metastases

Metastatic Breast Cancer

Treatments

Drug: oxaliplatin, capecitabine, trastuzumab

Study type

Interventional

Funder types

Other

Identifiers

NCT01387373

MA 0919

Details and patient eligibility

About

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 without extrahepatic disease are included.

Enrollment

14 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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 excluded 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.