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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 in Patients With Limited Extrahepatic Disease


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 in Patients With Limited Extrahepatic Disease


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.

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 last patient included

Safety Issue:

No

Principal Investigator

Dorte Nielsen, Professor

Investigator Role:

Principal Investigator

Investigator Affiliation:

professor

Authority:

Denmark: Danish Medicines Agency

Study ID:

MA 0918

NCT ID:

NCT01387295

Start Date:

April 2010

Completion Date:

December 2014

Related Keywords:

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

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