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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Herlev Hospital
Sponsor:
Information provided by (Responsible Party):
Dorte Nielsen, Herlev Hospital
ClinicalTrials.gov Identifier:
NCT01387373
First received: May 31, 2011
Last updated: March 20, 2014
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Metastatic Breast Cancer
Liver Metastases
Drug: oxaliplatin, capecitabine, trastuzumab
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Herlev Hospital:

Primary Outcome Measures:
  • Response rate [ Time Frame: 6 months after inclusion of last patient ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Time to progression a) Intrahepatic progression b) Extrahepatic progression [ Time Frame: 6 months after inclusion of last patient ] [ Designated as safety issue: No ]
    Time from treatment start to progression of disease or death of any cause.

  • Number of patients suitable for local therapy (radiofrequency) [ Time Frame: 6 months after inclusion of last patient ] [ Designated as safety issue: No ]
    Total number of patients receiving RF treatment or surgical treatment

  • Survival [ Time Frame: 6 months after inclusion of last patient ] [ Designated as safety issue: No ]
    All patients in intent-to-treat population , calculated from start of treatment to death of any cause

  • Toxicity [ Time Frame: 28 days after last patient last dose ] [ Designated as safety issue: Yes ]
    All patients who received at least one dose of study drug are evaluable for toxicity. CTC version 3.0 will be used.


Estimated Enrollment: 100
Study Start Date: April 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: chemotherapy Drug: oxaliplatin, capecitabine, trastuzumab
Oxaliplatin intrahepatic capecitabine + trastuzumab systemic
Other Name: HAI

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01387373

Contacts
Contact: Dorte Nielsen, Professor +4544884000 ext 82344 dornie01@heh.regionh.dk
Contact: Birgitte Krogh Jensen, Study nurse +4544884000 ext 89562 bikrje01@heh.regionh.dk

Locations
Denmark
Herlev Hospital Recruiting
Herlev, Denmark, DK-2730
Contact: Dorte Nielsen, Professor    +4544884000 ext 82344    dornie01@heh.regionh.dk   
Contact: Birgitte Krogh Jensen, Study nurse    +454488000 ext 89562    bikrje01@heh.regionh.dk   
Principal Investigator: Dorte Nielsen, professor         
Herlev Hospital Recruiting
Herlev, Denmark, DK-2730
Contact: Dorte Nielsen    +4544884000 ext 82344      
Principal Investigator: Dorte Nielsen, professor         
Sponsors and Collaborators
Dorte Nielsen
Investigators
Principal Investigator: Dorte Nielsen, Professor professor
  More Information

No publications provided

Responsible Party: Dorte Nielsen, Responsible Party was entered in the old format as Dorte Nielsen, professor DMSci, Department of Oncology, Herlev Hospital., Herlev Hospital
ClinicalTrials.gov Identifier: NCT01387373     History of Changes
Other Study ID Numbers: MA 0919
Study First Received: May 31, 2011
Last Updated: March 20, 2014
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by Herlev Hospital:
breast cancer
metastatic
liver metastases
intrahepatic
chemotherapy

Additional relevant MeSH terms:
Liver Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Breast Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases
Neoplastic Processes
Pathologic Processes
Breast Diseases
Skin Diseases
Trastuzumab
Capecitabine
Oxaliplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 16, 2014