Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Taxotere Xeloda | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Docetaxel | Drug | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| CT scan | Every 9 weeks | |
| Toxicity assessment | Every three weeks | |
| Quality of life |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Signe Friesland, MD, PhD | Karolinska University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Haukeland universitetssykehus | Bergen | 5021 | Norway | |||
| Oslo universitetssykehus, Radiumhospitalet |
Not provided
| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Capecitabine | Drug | 1650 mg/m2 /day orally b.i.d., day 1-14 every 3 weeks. |
|
|
| Every three weeks |
| Oslo |
| 0310 |
| Norway |
| Oslo universitetssykehus, Ullevål | Oslo | 0407 | Norway |
| St Olavs Hospital | Trondheim | 7006 | Norway |
| Linköping University Hospital | Linköping | 581 85 | Sweden |
| Malmö General University Hospital | Malmö | 20502 | Sweden |
| Karolinska University Hospital, Dept of Oncology | Stockholm | 171 76 | Sweden |
| Sundsvall County Hospital | Sundsvall | 851 86 | Sweden |
| Uppsala Akademic Hospital | Uppsala | 751 85 | Sweden |
| Västerås Central Hospital | Västerås | 721 89 | Sweden |
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |