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

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:
NCT01387295
First received: May 31, 2011
Last updated: March 20, 2014
Last verified: June 2013

May 31, 2011
March 20, 2014
April 2010
December 2014   (final data collection date for primary outcome measure)
Response rate [ Time Frame: 6 months after last patient included ] [ 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
Same as current
Complete list of historical versions of study NCT01387295 on ClinicalTrials.gov Archive Site
  • Number of patients suitable for local therapy (radiofrequency) [ Time Frame: 6 months after last patient included ] [ Designated as safety issue: No ]
    Total number of patients receiving RF treatment or surgical treatment
  • Survival [ Time Frame: 6 months after last patient included ] [ Designated as safety issue: No ]
    All patients in intent-to-treat population , calculated from start of treatment to death of any course
  • toxicity [ Time Frame: 28 days after last treatment of last patient ] [ 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.
  • PFS [ Time Frame: 6 months after last patient included ] [ Designated as safety issue: No ]
    From start of therapy to progression or death of any cause.
Same as current
Not Provided
Not Provided
 
Intra-hepatic Chemotherapy in Patients With Liver Metastases From Breast Cancer and Limited Extrahepatic Disease
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

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Metastatic Breast Cancer
  • Liver Metastases
Drug: oxaliplatin, capecitabine, trastuzumab
Oxaliplatin intrahepatic capecitabine and trastuzumab systemic
Other Name: HAI
Experimental: chemotherapy
Intervention: Drug: oxaliplatin, capecitabine, trastuzumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
December 2014
December 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Dorte Nielsen, Professor +4544884000 ext 82344 dornie01@heh.regionh.dk
Contact: Birgitte Krogh Jensen, Study nurse +4544884000 ext 89562 bikrje01@heh.regionh.dk
Denmark
 
NCT01387295
MA 0918
Yes
Dorte Nielsen, Herlev Hospital
Dorte Nielsen
Not Provided
Principal Investigator: Dorte Nielsen, Professor professor
Herlev Hospital
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP