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

NCT01387373 | Completed Phase 2

• 1 other identifier: MA 0919
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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

Keywords

breast cancer; metastatic; liver metastases; intrahepatic; chemotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Time to progression a) Intrahepatic progression b) Extrahepatic progression

  6 months after inclusion of last patient

• Number of patients suitable for local therapy (radiofrequency)

  6 months after inclusion of last patient

• Survival

  6 months after inclusion of last patient

• Toxicity

  28 days after last patient last dose

Study Arms (1)

chemotherapy

EXPERIMENTAL

Drug: oxaliplatin, capecitabine, trastuzumab

Interventions

oxaliplatin, capecitabine, trastuzumab DRUG

Oxaliplatin intrahepatic capecitabine + trastuzumab systemic

Also known as: HAI

chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 %.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Dorte Nielsen: lead

Study Sites (1)

Herlev Hospital

Herlev, DK-2730, Denmark

Location

MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis

Interventions

Oxaliplatin; Capecitabine; Trastuzumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Dorte Nielsen, Professor

  professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Responsible Party was entered in the old format as Dorte Nielsen, professor DMSci, Department of Oncology, Herlev Hospital.

Study Record Dates

• First Submitted: May 31, 2011
• First Posted: July 4, 2011
• Study Start: April 1, 2010
• Primary Completion: May 1, 2017
• Study Completion: September 1, 2017
• Last Updated: October 5, 2020

Record last verified: 2020-10

Locations

DK (1)