Intra-hepatic Chemotherapy in Patients With Liver Metastases From Breast Cancer and Limited Extrahepatic Disease

Metastatic Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01387295
• Other study ID #: MA 0918
• Status: Completed
• Phase: Phase 2
• Start date: April 2010
• Est. completion date: September 1, 2017

Study information

• Verified date: March 2023
• Source: Herlev Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: September 1, 2017
• Est. primary completion date: May 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Liver Metastases
• Liver Neoplasms
• Metastatic Breast Cancer
• Neoplasm Metastasis

Intervention

Drug:
• oxaliplatin, capecitabine, trastuzumab
Oxaliplatin intrahepatic capecitabine and trastuzumab systemic

Locations

Country	Name	City	State
Denmark	Herlev Hospital	Herlev

Sponsors (1)

Lead Sponsor	Collaborator
Dorte Nielsen

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response Rate	Number of patients with complete or partial response in the liver (RECIST version 1.1). Only patients with measurable disease are included in the protocol. Response rate number of patients with CR + PR divided with total number.; Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions,	up to 24 months from baseline
Secondary	Number of Patients Suitable for Local Therapy (Radiofrequency)	Total number of patients receiving RF treatment or surgical treatment	upon completion of treatment, an average of 7 months
Secondary	Survival	All patients in intent-to-treat population , calculated from start of treatment to death of any course	up to 7 years
Secondary	Adverse Events	Number of participants with at least 1 AE related to study treatment - The details on which AEs occured are listed in the Adverse Event section below	from start of treatment to 28 days after last treatment, an average of 7 months
Secondary	PFS	From start of therapy to progression or death of any cause.	up to 6 years