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Biweekly Docetaxel in Combination With Capecitabine as First-Line Treatment in Patients With Advanced Gastric Cancer (GAST-TaxXel)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2008 by University of Turku.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00669370
First Posted: April 30, 2008
Last Update Posted: April 30, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Sanofi
Information provided by:
University of Turku
  Purpose

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.


Condition Intervention Phase
Stomach Neoplasms Drug: docetaxel and capecitabine Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Biweekly Docetaxel (Taxotere®)in Combination With Capecitabine (Xeloda®)as First-Line Treatment in Patients With Advanced Gastric Cancer

Resource links provided by NLM:


Further study details as provided by University of Turku:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • To evaluate time to progression (TTP), overall response rate (ORR) and overall survival (OS). [ Time Frame: every 3 cycles, at the end of study and every 3 month ]

Estimated Enrollment: 50
Study Start Date: June 2006
Estimated Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: docetaxel and capecitabine
    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
    Other Names:
    • Taxotere
    • Xeloda
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • 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
  • 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.

Exclusion Criteria:

  • 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
  • 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00669370


Contacts
Contact: Raija Ristamäki, MD, PhD 358-2-313-0520 raija.ristamaki@tyks.fi
Contact: Seppo Pyrhönen, professor 358-2-313-2800 seppo.pyrhonen@tyks.fi

Locations
Finland
Kuopio University Hospital Recruiting
Kuopio, Finland, 70211
Contact: Päivi Auvinen, MD, PhD    358-17-172-907    paivi.auvinen@kuh.fi   
Principal Investigator: Päivi Auvinen, MD, PhD         
Sub-Investigator: Heli Virsunen, MD         
Oulu Univerity Hospital Recruiting
Oulu, Finland, 90029
Contact: Raija Kallio, Md, PhD    358-8-315-2011    raija.kallio@ppshp.fi   
Principal Investigator: Raija Kallio, MD, PhD         
Satakunta District Hospital Not yet recruiting
Pori, Finland, 22850
Contact: Maija-Leena Murashev, MD    358-2-62771    maija.murashev@satshp.fi   
Principal Investigator: Maija-Leena Murashev, MD         
University of Tampere Recruiting
Tampere, Finland, 33520
Contact: Tapio Salminen, MD    358-3-311-611    tapio.salminen@pshp.fi   
Principal Investigator: Tapio Salminen, MD         
Department of Oncology and Radiotherapy, turku University Hospital Recruiting
Turku, Finland, 20521
Contact: Raija ristamäki, MD, PhD    358-2-313-0520    raija.ristamaki@tyks.fi   
Sub-Investigator: Eija Korkeila, MD         
Principal Investigator: Raija Ristamäki, MD, PhD         
Sub-Investigator: Seppo Pyrhönen, professor         
Vaasa Distric Hospital Recruiting
Vaasa, Finland, 65100
Contact: Marjatta Mikkola, MD    358-6-323-2918    marjatta.mikkola@vshp.fi   
Principal Investigator: Marjatta Mikkola, MD         
Sponsors and Collaborators
University of Turku
Sanofi
Investigators
Principal Investigator: Raija Ristamäki, MD, PhD Department of Oncology and Radiotherapy, Turku University Hospital
  More Information

Responsible Party: Raija Ristamäki, Department of Oncology and Radiotherapy, Turku University Hospital
ClinicalTrials.gov Identifier: NCT00669370     History of Changes
Other Study ID Numbers: 2005-002484-87
EudraCT no 2005-002484-87
First Submitted: April 28, 2008
First Posted: April 30, 2008
Last Update Posted: April 30, 2008
Last Verified: April 2008

Keywords provided by University of Turku:
advanced gastric cancer
adenocarcinoma

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Docetaxel
Capecitabine
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites