Intra-hepatic Chemotherapy in Patients With Liver Metastases From Breast Cancer and Limited Extrahepatic Disease
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2013 by Herlev Hospital.
Recruitment status was: Recruiting
Information provided by (Responsible Party):
Dorte Nielsen, Herlev Hospital
First received: May 31, 2011
Last updated: March 20, 2014
Last verified: June 2013
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.
Metastatic Breast Cancer
Drug: oxaliplatin, capecitabine, trastuzumab
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||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
Primary Outcome Measures:
Secondary Outcome Measures:
- 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.
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2014 (Final data collection date for primary outcome measure)
Drug: oxaliplatin, capecitabine, trastuzumab
Oxaliplatin intrahepatic capecitabine and trastuzumab systemic
Other Name: HAI
|Ages Eligible for Study:
||18 Years and older (Adult, Senior)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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 %
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01387295
|Herlev, Denmark, DK-2730 |
||Dorte Nielsen, Professor
||Dorte Nielsen, Responsible Party was entered in the old format as Dorte Nielsen, professor DMSci, Department of Oncology, Herlev Hospital., Herlev Hospital
History of Changes
|Other Study ID Numbers:
|Study First Received:
||May 31, 2011
||March 20, 2014
||Denmark: Danish Medicines Agency
Keywords provided by Herlev Hospital:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 08, 2016
Neoplasms, Second Primary
Neoplasms by Site
Digestive System Neoplasms
Digestive System Diseases
Molecular Mechanisms of Pharmacological Action