Clinical trial NCT01387373: Intra-hepatic Chemotherapy in Patient With Non-resectable Liver Metastases From Breast Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Breast Cancer
Liver Metastases
Keywords: breast cancer
metastatic
liver metastases
intrahepatic
chemotherapy
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
First posted: 2011-07-04
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Response rate
timeFrame: 6 months after inclusion of last patient
Secondary outcomes:
measure: Time to progression a) Intrahepatic progression b) Extrahepatic progression
timeFrame: 6 months after inclusion of last patient
measure: Number of patients suitable for local therapy (radiofrequency)
timeFrame: 6 months after inclusion of last patient
measure: Survival
timeFrame: 6 months after inclusion of last patient
measure: Toxicity
timeFrame: 28 days after last patient last dose
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Herlev Hospital
Study officials:
affiliation: professor
name: Dorte Nielsen, Professor
role: PRINCIPAL_INVESTIGATOR
References: