EUCTR2012-005329-56-DK
Active, not recruiting
Not Applicable
A phase ll trial of combination chemotherapy with intravenous oxaliplatin combined with tablet capecitabin in patients with recidivant breastcancer - capox
Dept of oncology0 sites50 target enrollmentMay 16, 2013
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- breastcancer with metastases
- Sponsor
- Dept of oncology
- Enrollment
- 50
- Status
- Active, not recruiting
- Last Updated
- 10 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Informed concent Age \> 18 years
- •Performance status 0\-1; expected survival \> 3 months
- •Prior treatment with a Taxane and antracyclin
- •No treatment with capecitabine and oxaliplatin
- •Evaluable disease (recist 1\.1\)
- •neu granulocytes \> 1,5, thrombocytes \>100
- •bilirubine \<2 x UNL
- •Creatinine\-clearence \>30 ml/min
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
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
- •Previous treatment with oxaliplatin
- •Cytotoxic or experimental treatment within a 14 days period before
- •start of trial medication
- •Current participation in other clinical trials
- •Any clinical symptoms suggesting peripheral neuropathy grade 2 or
- •CNS metastases (In case of clinical suspicion on CNS metastases a MR or
Outcomes
Primary Outcomes
Not specified
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