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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01387373
• Other study ID #: MA 0919
• Status: Completed
• Phase: Phase 2
• Start date: April 2010
• Est. completion date: September 1, 2017

Study information

• Verified date: October 2020
• 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 without extrahepatic disease are included.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• 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 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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Liver Metastases
• Liver Neoplasms
• Metastatic Breast Cancer
• Neoplasm Metastasis
• Neoplasms, Second Primary

Intervention

Drug:
• oxaliplatin, capecitabine, trastuzumab
Oxaliplatin intrahepatic capecitabine + 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, 

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	6 months after inclusion of last patient
Secondary	Time to progression a) Intrahepatic progression b) Extrahepatic progression	Time from treatment start to progression of disease or death of any cause.	6 months after inclusion of last patient
Secondary	Number of patients suitable for local therapy (radiofrequency)	Total number of patients receiving RF treatment or surgical treatment	6 months after inclusion of last patient
Secondary	Survival	All patients in intent-to-treat population , calculated from start of treatment to death of any cause	6 months after inclusion of last patient
Secondary	Toxicity	All patients who received at least one dose of study drug are evaluable for toxicity. CTC version 3.0 will be used.	28 days after last patient last dose