Status:
COMPLETED
Weekly Taxol Plus Xeloda® vs Taxotere q3wk Plus Xeloda® in the Treatment of Metastatic BC
Lead Sponsor:
Norwegian Breast Cancer Group
Conditions:
Breast Neoplasm
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
PHASE3
Brief 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.
Detailed Description
Open labeled randomized multicentre phase II/III trial. It is intended to include patients who are not usually included into clinical trials because they are not having disease with measurable lesions...
Eligibility Criteria
Inclusion
- Morphologically proven breast carcinoma
- Written 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
- 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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Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2008
Estimated Enrollment :
224 Patients enrolled
Trial Details
Trial ID
NCT00201435
Start Date
March 1 2005
End Date
May 1 2008
Last Update
May 20 2008
Active Locations (1)
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1
Ullevål university hospital
Oslo, Norway, 0407