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

April 29, 2008 updated by: University of Turku

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Finland
      • Kuopio, Finland, 70211
        • Recruiting
        • Kuopio University Hospital
        • Contact:
        • Principal Investigator:
          • Päivi Auvinen, MD, PhD
        • Sub-Investigator:
          • Heli Virsunen, MD
      • Oulu, Finland, 90029
        • Recruiting
        • Oulu Univerity Hospital
        • Contact:
        • Principal Investigator:
          • Raija Kallio, MD, PhD
      • Pori, Finland, 22850
        • Not yet recruiting
        • Satakunta District Hospital
        • Contact:
        • Principal Investigator:
          • Maija-Leena Murashev, MD
      • Tampere, Finland, 33520
        • Recruiting
        • University of Tampere
        • Contact:
        • Principal Investigator:
          • Tapio Salminen, MD
      • Turku, Finland, 20521
        • Recruiting
        • Department of Oncology and Radiotherapy, turku University Hospital
        • Contact:
        • Sub-Investigator:
          • Eija Korkeila, MD
        • Principal Investigator:
          • Raija Ristamäki, MD, PhD
        • Sub-Investigator:
          • Seppo Pyrhönen, professor
      • Vaasa, Finland, 65100
        • Recruiting
        • Vaasa Distric Hospital
        • Contact:
        • Principal Investigator:
          • Marjatta Mikkola, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
at baseline and on day 1 at every cycle, at the end of study and every 8 week until progress

Secondary Outcome Measures

Outcome Measure
Time Frame
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
every 3 cycles, at the end of study and every 3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Turku

Collaborators

Sanofi

Investigators

  • Principal Investigator: Raija Ristamäki, MD, PhD, Department of Oncology and Radiotherapy, turku University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (Anticipated)

March 1, 2009

Study Registration Dates

First Submitted

April 28, 2008

First Submitted That Met QC Criteria

April 29, 2008

First Posted (Estimate)

April 30, 2008

Study Record Updates

Last Update Posted (Estimate)

April 30, 2008

Last Update Submitted That Met QC Criteria

April 29, 2008

Last Verified

April 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2005-002484-87
  • EudraCT no 2005-002484-87

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stomach Neoplasms

Clinical Trials on docetaxel and capecitabine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Myanmar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe