TaxXel: Taxotere and Xeloda in Esophageal Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

93 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2013-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Cancer of the Esophagus Gastric Cardia Carcinoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Docetaxel

Intervention Type 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

Capecitabine

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Capecitabine

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

Intervention Type DRUG

Other Intervention Names

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Taxotere Xeloda

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No