Intra-hepatic Chemotherapy in Patients With Liver Metastases From Breast Cancer and Limited Extrahepatic Disease
Conditions
Metastatic Breast Cancer - Liver Metastases
Conditions: official terms
Breast Neoplasms - Liver Neoplasms - Neoplasm Metastasis
Conditions: Keywords
breast cancer, liver metastases, intrahepatic chemotherapy
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: oxaliplatin, capecitabine, trastuzumab
Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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.
Location
Herlev Hospital
Herlev, Denmark
Status: Recruiting
Contact: Dorte Nielsen, Professor - +4544884000 - dornie01@heh.regionh.dk
Start Date
April 2010
Completion Date
December 2014
Sponsors
Dorte Nielsen
Source
Herlev Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page