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

NCT ID: NCT01387373

Last Updated: 2020-10-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2017-09-01

Brief 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 without extrahepatic disease are included.

Conditions

Metastatic Breast Cancer; Liver Metastases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

chemotherapy

Group Type: EXPERIMENTAL

oxaliplatin, capecitabine, trastuzumab

Intervention Type: DRUG

Oxaliplatin intrahepatic capecitabine + trastuzumab systemic

Interventions

oxaliplatin, capecitabine, trastuzumab

Oxaliplatin intrahepatic capecitabine + trastuzumab systemic

Intervention Type: DRUG

Other Intervention Names

HAI

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dorte Nielsen

OTHER

Sponsor Role: lead

Responsible Party

Dorte Nielsen

Responsible Party was entered in the old format as Dorte Nielsen, professor DMSci, Department of Oncology, Herlev Hospital.

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Dorte Nielsen, Professor

Role: PRINCIPAL_INVESTIGATOR

professor

Locations

Herlev Hospital

Herlev, , Denmark

Countries

Denmark

Other Identifiers

MA 0919

Identifier Type: -

Identifier Source: org_study_id