Clinical trial NCT01387295: Intra-hepatic Chemotherapy in Patients With Liver Metastases From Breast Cancer and Limited Extrahepatic Disease
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 in Patients With Limited Extrahepatic Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Breast Cancer
Liver Metastases
Keywords: breast cancer
liver metastases
intrahepatic chemotherapy
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
First posted: 2011-07-04
Enrollment: 38
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 with limited 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 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.

Primary outcomes:
measure: Response Rate
timeFrame: up to 24 months from baseline
Secondary outcomes:
measure: Number of Patients Suitable for Local Therapy (Radiofrequency)
timeFrame: upon completion of treatment, an average of 7 months
measure: Survival
timeFrame: up to 7 years
measure: Adverse Events
timeFrame: from start of treatment to 28 days after last treatment, an average of 7 months
measure: PFS
timeFrame: up to 6 years
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Herlev Hospital
Study officials:
affiliation: professor
name: Dorte Nielsen, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lindgaard SC, Brinch CM, Jensen BK, Norgaard HH, Hermann KL, Theile S, Larsen FO, Jensen BV, Michelsen H, Nelausen KM, Holm VH, Ekblad L, Soerensen PG, Nielsen DL. Hepatic arterial therapy with oxaliplatin and systemic capecitabine for patients with liver metastases from breast cancer. Breast. 2019 Feb;43:113-119. doi: 10.1016/j.breast.2018.12.002. Epub 2018 Dec 5.