This is an open label, non-randomised, multicentre phase 1-2 study with a fixed dose of Taxotere in combination with Xeloda which is dose escalated during the first phase of the study (modified Fibonacci design) and fixed during the second phase. The primary objective of the phase 1 part is to define the dose recommended for the Phase II part of the study. The primary objective is to determine the response rate.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
93
30 mg/m2, administered as a 30 min. i.v. infusion on cycle day 1, 8 and 15 or cycle day 1 and 8 in an alternating 3 weekly schedule
1650 mg/m2 /day orally b.i.d., day 1-14 every 3 weeks.
Haukeland universitetssykehus
Bergen, Norway
Oslo universitetssykehus, Radiumhospitalet
Oslo, Norway
Oslo universitetssykehus, Ullevål
Oslo, Norway
St Olavs Hospital
Trondheim, Norway
Response rate
Response rate will be defined as the percentage of patients who achieve a complete response (CR) or partial response (PR). Duration of a CR or PR will be calculated from the time that measurement criteria are met for complete response or partial response until the first date that recurrent or progressive disease is objectively documented.
CT scan
Time frame: Every 9 weeks
Toxicity assessment
Time frame: Every three weeks
Quality of life
Time frame: Every three weeks
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Linköping University Hospital
Linköping, Sweden
Malmö General University Hospital
Malmo, Sweden
Karolinska University Hospital, Dept of Oncology
Stockholm, Sweden
Sundsvall County Hospital
Sundsvall, Sweden
Uppsala Akademic Hospital
Uppsala, Sweden
Västerås Central Hospital
Västerås, Sweden