TaxXel: Taxotere and Xeloda in Esophageal Cancer

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

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00821912

Acronym

TaxXel

Enrollment

Registered

2009-01-14

Start date

2006-03-31

Completion date

2013-09-30

Last updated

2012-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer of the Esophagus, Gastric Cardia Carcinoma

Brief summary

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.

Interventions

DRUGDocetaxel

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

DRUGCapecitabine

1650 mg/m2 /day orally b.i.d., day 1-14 every 3 weeks.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Secondary

Measure	Time frame
CT scan	Every 9 weeks
Toxicity assessment	Every three weeks
Quality of life	Every three weeks

Countries

Norway, Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026