Overview
Weekly Taxol Plus Xeloda® vs Taxotere q3wk Plus Xeloda® in the Treatment of Metastatic BC
Status:
Completed
Completed
Trial end date:
2008-05-01
2008-05-01
Target enrollment:
0
0
Participant gender:
Female
Female
Summary
We want to compare Taxol given weekly with Taxotere given every 3 week both in comination with Xeloda. We are going to compare time to treatment failure and quality of life.Phase:
Phase 2/Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Norwegian Breast Cancer GroupTreatments:
Albumin-Bound Paclitaxel
Capecitabine
Docetaxel
Paclitaxel
Criteria
Inclusion Criteria: Morphologically proven breast carcinomaWritten informed patient consent Measurable and/or evaluable disease Measurable disease is
defined as least one lesion that can be accurately measured in at least one dimension as
≥20 mm by conventional techniques, or as ≥10 mm by spiral CT scan) as defined in section 8.
Evaluable metastases. Lytic bone metastases as only site of recurrence are allowed and can
be evaluated for response according to the WHO-criteria for reporting on response in bone
metastases.
Age 18 years or older ECOG Performance Status 0-2 Life expectancy of at least three months
Adequate cardiac functions
Adequate hematological, renal and hepatic functions, defined as:
White blood cell count > 3.9 x 109/L Trombocytes > 100 x 109/L Serum creatinine < 1.25 x
ULN* Bilirubin < 1.5 ULN If alkaline phosphatases (ALP) is normal ALAT < 3.5 ULN ASAT < 3.5
ULN If alkaline phosphatases (ALP) is > 2.5 ULN ALAT < 1.5 ULN ASAT < 1.5 ULN
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Exclusion Criteria: Recurrence-free interval less than one year, if previous adjuvant or
neoadjuvant regimen contained a taxane
Neoplasm other than breast carcinoma, except for non-melanoma skin cancer or curatively
treated carcinoma in situ of the cervix, diagnosed during the past five years
Pregnancy or lactation
Known brain metastases
Preexisting motor or sensory neuropathy ≥ grade 2 according to NCI CTC 2.0 criteria (severe
paresthesia and/or mild weakness, or worse)
Severe hepatic or renal impairment (for capecitabine: calculated creatinine clearance below
30 ml/min; for calculation, see p. 5.1.4) not allowing for adequate use of the proposed
regimens
History of known dihydropyrimidine dehydrogenase (DPD) deficiency (severe reaction on
previous treatment with fluorouracil)
Active infection or other serious underlying medical condition which would impair the
ability of the patient to receive protocol treatment, including prior allergic reactions to
drugs containing cremophor, such as teniposide, cyclosporine or vitamin K
Dementia or significantly altered mental status that would prohibit the understanding and
giving of informed consent.
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