Suspended

Phase II Study of Docetaxel and Epirubicine as First-Line Treatment in Patients With Advanced or Metastatic Adenocarcinoma of the Stomach

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What is being tested

Data Collection

Who is being recruted

Adenocarcinoma+9

+ Carcinoma

+ Digestive System Diseases

From 18 to 75 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: April 2001
See protocol details

Summary

Principal SponsorGERCOR - Multidisciplinary Oncology Cooperative Group
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2001

Actual date on which the first participant was enrolled.

OBJECTIVES: Primary * Determine the objective tumor response rate and time to tumor progression in patients with locally advanced or metastatic adenocarcinoma of the stomach treated with docetaxel and epirubicin as first-line therapy. Secondary * Determine the survival without local relapse and overall survival of patients treated with this regimen. * Determine the tolerance to this regimen in these patients. OUTLINE: This is an open-label, multicenter study. Patients receive epirubicin IV over 30 minutes and docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 39 patients will be accrued for this study.

Official TitlePhase II Study of Docetaxel and Epirubicine as First-Line Treatment in Patients With Advanced or Metastatic Adenocarcinoma of the Stomach 
NCT00075465
Principal SponsorGERCOR - Multidisciplinary Oncology Cooperative Group
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AdenocarcinomaCarcinomaDigestive System DiseasesDigestive System NeoplasmsGastrointestinal DiseasesGastrointestinal NeoplasmsNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Glandular and EpithelialStomach DiseasesStomach Neoplasms

Criteria

DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the stomach * Locally advanced or metastatic disease * Measurable disease * At least 1 unidimensionally measurable target lesion at least 2 cm in diameter * No known symptomatic brain metastases * No bone metastases PATIENT CHARACTERISTICS: Age * 18 to 75 Performance status * ECOG 0-2 Life expectancy * At least 3 months Hematopoietic * Absolute neutrophil count at least 2,000/mm\^3 * Platelet count greater than 100,000/mm\^3 Hepatic * Bilirubin less than 2 times normal * AST and ALT no greater than 2.5 times normal * Alkaline phosphatase no greater than 2.5 times normal Renal * Creatinine less than 1.6 mg/dL OR * Creatinine clearance greater than 60 mL/min Cardiovascular * No serious cardiac failure within the past 12 months * No myocardial infarction within the past 12 months * No cardiac insufficiency * No angina Other * Not pregnant or nursing * Fertile patients must use effective contraception * No uncontrolled serious infection * No significant brain or psychiatric disorders * No intolerance to cortisone or polysorbate 80 * No other prior malignancy except curatively treated basal cell skin cancer or carcinoma in situ of the cervix * No other illness or medical condition that would preclude study participation * No peripheral neuropathy greater than grade 2 PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior chemotherapy Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified Other * More than 21 days since prior participation in another clinical study * No other concurrent experimental medication

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 23 locations

Suspended

Centre Paul Papin

Angers, FranceSee the location
Suspended

Centre Hospitalier Victor Dupouy

Argenteuil, France
Suspended

Centre Hospital General Robert Ballanger

Aulnay Sous Bois, France
Suspended

C.H.G. Beauvais

Beauvais, France
Suspended23 Study Centers