TaxXel: Taxotere and Xeloda in Esophageal Cancer
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.
Cancer of the Esophagus
Gastric Cardia Carcinoma
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I/II Study on the Treatment With Taxotere in Combination With Xeloda in Patients With Metastatic Oesophageal Cancer or Cancer in the Cardia Region|
- Response rate [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
- Toxicity assessment [ Time Frame: Every three weeks ] [ Designated as safety issue: Yes ]
- Quality of life [ Time Frame: Every three weeks ] [ Designated as safety issue: No ]
|Study Start Date:||March 2006|
|Estimated Study Completion Date:||September 2013|
|Estimated Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
Experimental: Taxotere Xeloda
Taxotere i.v. infusion on cycle day 1, 8 and 15 or cycle day 1 and 8 in an alternating 3 weekly schedule.
Xeloda orally day 1-14 every 3 weeks.
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
Other Name: TaxotereDrug: Capecitabine
1650 mg/m2 /day orally b.i.d., day 1-14 every 3 weeks.
Other Name: Xeloda
|Bergen, Norway, 5021|
|Oslo universitetssykehus, Radiumhospitalet|
|Oslo, Norway, 0310|
|Oslo universitetssykehus, Ullevål|
|Oslo, Norway, 0407|
|St Olavs Hospital|
|Trondheim, Norway, 7006|
|Linköping University Hospital|
|Linköping, Sweden, 581 85|
|Malmö General University Hospital|
|Malmö, Sweden, 20502|
|Karolinska University Hospital, Dept of Oncology|
|Stockholm, Sweden, 171 76|
|Sundsvall County Hospital|
|Sundsvall, Sweden, 851 86|
|Uppsala Akademic Hospital|
|Uppsala, Sweden, 751 85|
|Västerås Central Hospital|
|Västerås, Sweden, 721 89|
|Principal Investigator:||Signe Friesland, MD, PhD||Karolinska University Hospital|