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Stomach NeoplasmsPhase 2GAST-TaxXelNCT00669370

Biweekly Docetaxel in Combination With Capecitabine as First-Line Treatment in Patients With Advanced Gastric Cancer

A Phase 2 study testing docetaxel and capecitabine in people with Stomach Neoplasms, run by University of Turku at 6 sites in Finland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To determine the quality of life in patients with gastric cancer who receive combination treatment with docetaxel and capecitabine. Secondary endpoints are time to progression, overall response rate and overall survival. Study treatment will continue until disease progression or unacceptable toxicity. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stomach Neoplasms
What is being tested?
docetaxel and capecitabine
Type of treatment
Injection or infusion
How many people
50 participants
Where
6 sitesFinland
Study dates
Jun 2006to Mar 2009
Phase
Phase 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 advanced, inoperable gastric adenocarcinoma
  • age ≥18 years
  • WHO performance status ≤ 2
  • Stage IV
  • Measurable (according to RECIST criteria) or evaluable lesion
  • No previous chemotherapy, except adjuvant chemotherapy ≥ 6 months ago
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  • Adequate hematological function (neutrophils ≥ 1.5 x 109/l and platelets ≥ 100 x 109/l, Hb ≥ 100 g/l (after transfusion when needed)
  • Adequate renal function (serum creatinine ≤ 1.25 x upper normal limit)
  • Adequate liver function (total serum bilirubin ≤ 1.25 x upper normal limit or ALAT ≤ 3 x upper normal limit; in case of liver metastasis: total serum bilirubin ≤ 1.5 x upper normal limit, ALAT ≤ 5 x upper normal limit)
  • AFOS ≤ 2.5 x upper normal limit (unless bone metastases)
  • Consent form signed and dated before inclusion
  • Able to comply with the scheduled follow-up and with the management of toxicities.

Who cannot join

  • Pregnant or lactating women (or potentially fertile women not using adequate contraception)
  • Presence of CNS metastases
  • Unresolved bowel obstruction or subobstruction
  • Chronic diarrhea
  • Clinically significant malabsorption syndrome
  • Inability to swallow tablets
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  • Known dihydropyrimidine dehydrogenase (DPD) deficiency
  • Concurrent severe and/or uncontrolled co-morbid medical condition such as uncontrolled infection, hypertension, ischemic heart disease, myocardial infarction within previous 6 months, congestive heart failure
  • History of previous or concurrent malignancy within the previous 5 years except curatively treated carcinoma in situ of the uterine cervix or basal cell carcinoma of the skin
  • History of prior serious allergic reactions such as anaphylactic shock.
  • Peripheral neuropathy ≥ grade 2, unless related to mechanical etiology
  • Concurrent use of corticosteroids unless chronic treatment (i.e. initiated > 6 months prior to study entry) at low doses (≥ 20 mg methylprednisolone or equivalent)
  • History of allergy to drugs containing the excipient TWEEN 80® and/ or 5- fluorouracil.
  • Lack of physical integrity of the upper gastrointestinal tract.
  • Concomitant administration of any other experimental drug under investigation: concurrent treatment with any other anti-cancer therapy.
  • Major surgery within 4 weeks prior to study treatment start, or lack of complete recovery from the effects of major surgery.
  • Patients who cannot be regularly followed up for psychological, social, family or geographic reasons.

Trial locations and contacts

6 sites in 1 country.

Raija Ristamäki, MD, PhD contact

358-2-313-0520

raija.ristamaki@tyks.fi

Seppo Pyrhönen, professor contact

358-2-313-2800

seppo.pyrhonen@tyks.fi

6 sites in 1 country

Finland6 sites, 6 recruiting

  • Kuopio University Hospital

    Kuopio, 70211

    Päivi Auvinen, MD, PhD, 358-17-172-907, paivi.auvinen@kuh.fi

    Päivi Auvinen, MD, PhD

    Recruiting

  • Oulu Univerity Hospital

    Oulu, 90029

    Raija Kallio, Md, PhD, 358-8-315-2011, raija.kallio@ppshp.fi

    Raija Kallio, MD, PhD

    Recruiting

  • Satakunta District Hospital

    Pori, 22850

    Maija-Leena Murashev, MD, 358-2-62771, maija.murashev@satshp.fi

    Maija-Leena Murashev, MD

    Not yet recruiting

  • University of Tampere

    Tampere, 33520

    Tapio Salminen, MD, 358-3-311-611, tapio.salminen@pshp.fi

    Tapio Salminen, MD

    Recruiting

  • Department of Oncology and Radiotherapy, turku University Hospital

    Turku, 20521

    Raija ristamäki, MD, PhD, 358-2-313-0520, raija.ristamaki@tyks.fi

    Eija Korkeila, MD

    Recruiting

  • Vaasa Distric Hospital

    Vaasa, 65100

    Marjatta Mikkola, MD, 358-6-323-2918, marjatta.mikkola@vshp.fi

    Marjatta Mikkola, MD

    Recruiting

Other trials in Finland

About this study

Official title: Biweekly Docetaxel (Taxotere®)in Combination With Capecitabine (Xeloda®)as First-Line Treatment in Patients With Advanced Gastric Cancer

To determine the quality of life in patients with gastric cancer who receive combination treatment with docetaxel and capecitabine. Secondary endpoints are time to progression, overall response rate and overall survival.

Study treatment will continue until disease progression or unacceptable toxicity.

Read the detailed description

GAST-TaxXel is an open, phase II, single arm, non-randomized, Finnish multicenter trial. At least 50 subjects will be enrolled.

Primary endpoint:

To determine the quality of life (EORTC QLQ-C30 and QLQ-STO22) in patients with gastric cancer who receive combination treatment with Taxotere and Xeloda.

Secondary endpoint:

To evaluate time to progression (TTP), overall response rate (ORR) and overall survival (OS).

Quality of life: to evaluate that QOL does not deteriorate from baseline. Quality of life is measured using EORTC QLQ-C30 and QLQ-STO22 with physical functioning score as the primary variable.

Efficacy: time to progression, overall response rate, overall survival Time to progression is defined as time elapsed from inclusion to first documented progression or death whatever the reason. Overall response rate is assessed according to the RECIST criteria. Overall survival is defined as time elapsed from inclusion to death.

Safety: clinical and laboratory toxicities or symptomatology will be graded according to NCI-CTC criteria.

Statistical considerations:

The primary variable, physical functioning score measured by the EORTC QLQ-C30 and QLQ-STO22 instrument, will be analyzed using a paired t-test (change from baseline after two treatment cycles). A 95% confidence interval will also be calculated for the primary variable. Median TTP and OS will be estimated using the Kaplan-Meier method. The ORR will be summarized. Safety variables will be summarized descriptively.

Being tested
docetaxel and capecitabine
Keywords
advanced gastric cancer, adenocarcinoma
Medical subject headings
Stomach Neoplasms, Adenocarcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • docetaxel and capecitabineDrug

    Also called Taxotere, Xeloda

    biweekly docetaxel iv (50 mg/m2) on day 1 and 15 and capecitabine po 1250 mg/m2 x 2/day days 1-7 and 15-21, treatment cycle consisting of 21 days

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To determine the quality of life (EORTC QLQ-C30 and QLQ-STO22)

    Measured: at baseline and on day 1 at every cycle, at the end of study and every 8 week until progress

Secondary outcomes (1)

  1. To evaluate time to progression (TTP), overall response rate (ORR) and overall survival (OS).

    Measured: every 3 cycles, at the end of study and every 3 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Apr 2008 (estimated)
  2. Study startJun 2006
  3. Primary completionMar 2009 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00669370
Sponsor's protocol ID
2005-002484-87
Other IDs
EudraCT no 2005-002484-87, 2005
Acronym
GAST-TaxXel
Status last verified
Apr 2008
First submitted
28 Apr 2008
Last updated
30 Apr 2008
Results posted
No
Data monitoring committee
No

Publications

  • Korkeila EA, Salminen T, Kallio R, Mikkola M, Auvinen P, Pyrhonen S, Ristamaki R. Quality of life with biweekly docetaxel and capecitabine in advanced gastro-oesophageal cancer. Support Care Cancer. 2017 Sep;25(9):2771-2777. doi: 10.1007/s00520-017-3689-5. Epub 2017 Apr 20.

    PubMed 28424889

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing docetaxel and capecitabine in people with Stomach Neoplasms, run by University of Turku at 6 sites in Finland.

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 12 inclusion and 17 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 30 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Finland. 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 phase mean?

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?

Contact Raija Ristamäki, MD, PhD (358-2-313-0520, raija.ristamaki@tyks.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To determine the quality of life (EORTC QLQ-C30 and QLQ-STO22) (time frame: at baseline and on day 1 at every cycle, at the end of study and every 8 week until progress). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00669370, which also lists 1 linked publication.

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 30 Apr 2008.

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