Cancer of the EsophagusPhase 1/2TaxXelNCT00821912
TaxXel: Taxotere and Xeloda in Esophageal Cancer
A Phase 1/2 study testing Docetaxel and Capecitabine in people with Cancer of the Esophagus and Gastric Cardia Carcinoma, run by Karolinska University Hospital at 10 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer of the Esophagus, Gastric Cardia Carcinoma
- What is being tested?
- Docetaxel and Capecitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 10 sitesin 2 countries
- Study dates
- Mar 2006to Sep 2013
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
Sweden6 sites
Linköping University Hospital
Linköping, 581 85
Malmö General University Hospital
Malmö, 20502
Karolinska University Hospital, Dept of Oncology
Stockholm, 171 76
Sundsvall County Hospital
Sundsvall, 851 86
Uppsala Akademic Hospital
Uppsala, 751 85
Västerås Central Hospital
Västerås, 721 89
Norway4 sites
Haukeland universitetssykehus
Bergen, 5021
Oslo universitetssykehus, Radiumhospitalet
Oslo, 0310
Oslo universitetssykehus, Ullevål
Oslo, 0407
St Olavs Hospital
Trondheim, 7006
About this study
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
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.
- Conditions
- Cancer of the Esophagus, Gastric Cardia Carcinoma
- Being tested
- Docetaxel, Capecitabine
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DocetaxelDrug
Also called Taxotere
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
CapecitabineDrug
Also called Xeloda
1650 mg/m2 /day orally b.i.d., day 1-14 every 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Docetaxel; Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Every 9 weeks
Toxicity assessment
Measured: Every three weeks
Quality of life
Measured: Every three weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2009 (estimated)
- Study startMar 2006
- Primary completionSep 2012 (estimated)
- Study completionSep 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of the EsophagusStudies of the same condition, open and under way.
- More trials run by Karolinska University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Signe Friesland, Karolinska University Hospital
- Investigators
- Signe Friesland, MD, PhD, Principal investigator, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00821912
- Sponsor's protocol ID
- TaxXel
- Acronym
- TaxXel
- Status last verified
- Feb 2012
- First submitted
- 13 Jan 2009
- Last updated
- 28 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00821912
- Acronym / sponsor ID
- TaxXel / TaxXel
- Conditions
- Cancer of the Esophagus, Gastric Cardia Carcinoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Study start
- Mar 2006
- Primary completion
- Sep 2012 (estimated)
- Study completion
- Sep 2013 (estimated)
- First posted
- 14 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Taxotere Xeloda | Experimental | Drug: Docetaxel, Drug: CapecitabineTaxotere 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DocetaxelAlso: Taxotere30 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 | Drug | Taxotere Xeloda |
| CapecitabineAlso: Xeloda1650 mg/m2 /day orally b.i.d., day 1-14 every 3 weeks. | Drug | Taxotere Xeloda |
Primary outcome
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.
3 secondary outcomes
CT scan
Time frame: Every 9 weeks
Toxicity assessment
Time frame: Every three weeks
Quality of life
Time frame: Every three weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Signe Friesland, MD, PhD principal investigator
Karolinska University Hospital
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Docetaxel and Capecitabine in people with Cancer of the Esophagus and Gastric Cardia Carcinoma, run by Karolinska University Hospital at 10 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Sweden, Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2012.