NCT00821912

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
93

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2006

Longer than P75 for phase_1

Geographic Reach
2 countries

10 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

January 13, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 14, 2009

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

February 28, 2012

Status Verified

February 1, 2012

Enrollment Period

6.5 years

First QC Date

January 13, 2009

Last Update Submit

February 27, 2012

Conditions

Cancer of the EsophagusGastric Cardia Carcinoma

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • CT scan

    Every 9 weeks

  • Toxicity assessment

    Every three weeks

  • Quality of life

    Every three weeks

Study Arms (1)

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.

Drug: DocetaxelDrug: Capecitabine

Interventions

DocetaxelDRUG

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

Also known as: Taxotere
Taxotere Xeloda
CapecitabineDRUG

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

Also known as: Xeloda
Taxotere Xeloda

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Haukeland universitetssykehus

Bergen, 5021, Norway

Location

Oslo universitetssykehus, Radiumhospitalet

Oslo, 0310, Norway

Location

Oslo universitetssykehus, Ullevål

Oslo, 0407, Norway

Location

St Olavs Hospital

Trondheim, 7006, Norway

Location

Linköping University Hospital

Linköping, 581 85, Sweden

Location

Malmö General University Hospital

Malmo, 20502, Sweden

Location

Karolinska University Hospital, Dept of Oncology

Stockholm, 171 76, Sweden

Location

Sundsvall County Hospital

Sundsvall, 851 86, Sweden

Location

Uppsala Akademic Hospital

Uppsala, 751 85, Sweden

Location

Västerås Central Hospital

Västerås, 721 89, Sweden

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

DocetaxelCapecitabine

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Signe Friesland, MD, PhD

    Karolinska University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

January 13, 2009

First Posted

January 14, 2009

Study Start

March 1, 2006

Primary Completion

September 1, 2012

Study Completion

September 1, 2013

Last Updated

February 28, 2012

Record last verified: 2012-02

Locations

SE(6)NO(4)