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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Metastatic Breast Cancer, Liver Metastases

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Response rate

Outcome Description:

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

Outcome Time Frame:

6 months after inclusion of last patient

Safety Issue:

No

Principal Investigator

Dorte Nielsen, Professor

Investigator Role:

Principal Investigator

Investigator Affiliation:

professor

Authority:

Denmark: Danish Medicines Agency

Study ID:

MA 0919

NCT ID:

NCT01387373

Start Date:

April 2010

Completion Date:

December 2014

Related Keywords:

  • Metastatic Breast Cancer
  • Liver Metastases
  • breast cancer
  • metastatic
  • liver metastases
  • intrahepatic
  • chemotherapy
  • Breast Neoplasms
  • Neoplasm Metastasis
  • Neoplasms, Second Primary
  • Liver Neoplasms

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