TaxXel: Taxotere and Xeloda in Esophageal Cancer (TaxXel)
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ClinicalTrials.gov Identifier: NCT00821912 |
Recruitment Status : Unknown
Verified February 2012 by Signe Friesland, Karolinska University Hospital.
Recruitment status was: Active, not recruiting
First Posted : January 14, 2009
Last Update Posted : February 28, 2012
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cancer of the Esophagus Gastric Cardia Carcinoma | Drug: Docetaxel Drug: Capecitabine | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 93 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (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 |
Study Start Date : | March 2006 |
Estimated Primary Completion Date : | September 2012 |
Estimated Study Completion Date : | September 2013 |

Arm | Intervention/treatment |
---|---|
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. |
Drug: Docetaxel
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: Taxotere Drug: Capecitabine 1650 mg/m2 /day orally b.i.d., day 1-14 every 3 weeks.
Other Name: Xeloda |
- 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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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histologically confirmed squamous cell carcinoma or adenocarcinoma of the oesophagus or cardia.
- Inoperable metastatic disease
- Performance status (WHO) of 0-2
- Measurable disease.
- Adequate hematological, liver and renal function.
- Signed informed consent.
Exclusion Criteria:
- CNS metastases
- Symptomatic peripheral neuropathy equal to or greater than NCI grade 2.
- Other concomitant serious illness or medical condition.
- Past or current history of malignant neoplasm other than oesophageal carcinoma.
- <18 years of age. Pregnant or lactating patients.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00821912
Norway | |
Haukeland universitetssykehus | |
Bergen, Norway, 5021 | |
Oslo universitetssykehus, Radiumhospitalet | |
Oslo, Norway, 0310 | |
Oslo universitetssykehus, Ullevål | |
Oslo, Norway, 0407 | |
St Olavs Hospital | |
Trondheim, Norway, 7006 | |
Sweden | |
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 |
Responsible Party: | Signe Friesland, MD, PhD, Karolinska University Hospital |
ClinicalTrials.gov Identifier: | NCT00821912 |
Other Study ID Numbers: |
TaxXel |
First Posted: | January 14, 2009 Key Record Dates |
Last Update Posted: | February 28, 2012 |
Last Verified: | February 2012 |
Esophageal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Head and Neck Neoplasms Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases |
Docetaxel Capecitabine Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Antimetabolites |