AzTrials
AzTrials

Gastric CancerPhase 2NCT00075465

Docetaxel and Epirubicin as First-Line Therapy in Treating Patients With Locally Advanced or Metastatic Adenocarcinoma of the Stomach

A Phase 2 study testing docetaxel and epirubicin hydrochloride in people with Gastric Cancer, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 23 sites in France.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

Trial summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel and epirubicin, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one drug may kill more tumor cells. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Gastric Cancer
What is being tested?
docetaxel and epirubicin hydrochloride
How many people
Not given
Where
23 sitesFrance
Study dates
Apr 2001to not given
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

23 sites in 1 country.

23 sites in 1 country

France23 sites

  • Centre Paul Papin

    Angers, 49036

  • Centre Hospitalier Victor Dupouy

    Argenteuil, 95107

  • Centre Hospital General Robert Ballanger

    Aulnay-sous-Bois, 93602

  • C.H.G. Beauvais

    Beauvais, 60021

  • Clinique Tivoli

    Bordeaux, F-33000

  • Hopital Louis Pasteur

    Chartres, 28018

  • Hopital Drevon

    Dijon, 21000

  • Clinique Sainte-Marguerite

    Hyères, 83400

  • Clinique Victor Hugo

    Le Mans, F-72000

  • Centre Hospital Universitaire Hop Huriez

    Lille, 59037

  • Clinique Saint Jean

    Lyon, 69008

  • Hopital de la Croix Rousse

    Lyon, 69317

  • CHU de la Timone

    Marseille, 13385

  • Intercommunal Hospital

    Montfermeil, 93370

  • American Hospital of Paris

    Neuilly-sur-Seine, F-92202

  • Hopital Saint Antoine

    Paris, 75571

  • Hopital Saint Joseph

    Paris, 75674

  • Hopital Tenon

    Paris, 75970

  • Maison Medicale Marzet

    Pau, 64000

  • Hopital Rene Dubos

    Pontoise, 95300

  • C.H. Senlis

    Senlis, 60309

  • Hopital d'Instruction des Armes Sainte-Anne

    Toulon, 83800

  • CHRU de Tours - Hopital Trousseau

    Tours, 37044

Other trials in France

About this study

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

RATIONALE: Drugs used in chemotherapy, such as docetaxel and epirubicin, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one drug may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving docetaxel together with epirubicin as first-line therapy works in treating patients with locally advanced or metastatic adenocarcinoma (cancer) of the stomach.

Read the detailed description

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.

Conditions
Gastric Cancer
Being tested
docetaxel, epirubicin hydrochloride
Keywords
adenocarcinoma of the stomach, stage III gastric cancer, stage IV gastric cancer
Medical subject headings
Stomach Neoplasms

What participants receive

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

What is being measured

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

  1. Objective tumor response rate

  2. Time to tumor progression

Secondary outcomes (3)

  1. Survival without local relapse

  2. Overall survival

  3. Tolerability

Timeline

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

  1. First posted12 Jan 2004 (estimated)
  2. Study startApr 2001

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
Masking
None (open label)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00075465
Sponsor's protocol ID
CDR0000346617
Other IDs
FRE-GERCOR-EPITAXD00-1, EU-20326
Status last verified
Jul 2007
First submitted
9 Jan 2004
Last updated
24 Jul 2008
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing docetaxel and epirubicin hydrochloride in people with Gastric Cancer, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 23 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 24 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in France. 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?

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?

Objective tumor response rate. The study lists 2 primary outcomes in all. 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 NCT00075465.

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 24 Jul 2008.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in