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

Primary Purpose

Gastric Cancer

Status
Unknown status
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
docetaxel
epirubicin hydrochloride
Sponsored by
GERCOR - Multidisciplinary Oncology Cooperative Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring adenocarcinoma of the stomach, stage III gastric cancer, stage IV gastric cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Paul Papin
  • Centre Hospitalier Victor Dupouy
  • Centre Hospital General Robert Ballanger
  • C.H.G. Beauvais
  • Clinique Tivoli
  • Hopital Louis Pasteur
  • Hopital Drevon
  • Clinique Sainte-Marguerite
  • Clinique Victor Hugo
  • Centre Hospital Universitaire Hop Huriez
  • Clinique Saint Jean
  • Hopital de la Croix Rousse
  • CHU de la Timone
  • Intercommunal Hospital
  • American Hospital of Paris
  • Hopital Saint Antoine
  • Hopital Saint Joseph
  • Hopital Tenon
  • Maison Medicale Marzet
  • Hopital Rene Dubos
  • C.H. Senlis
  • Hopital d'Instruction des Armes Sainte-Anne
  • CHRU de Tours - Hopital Trousseau

Outcomes

Primary Outcome Measures

Objective tumor response rate
Time to tumor progression

Secondary Outcome Measures

Survival without local relapse
Overall survival
Tolerability

Full Information

First Posted
January 9, 2004
Last Updated
July 23, 2008
Sponsor
GERCOR - Multidisciplinary Oncology Cooperative Group
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1. Study Identification

Unique Protocol Identification Number
NCT00075465
Brief Title
Docetaxel and Epirubicin as First-Line Therapy in Treating Patients With Locally Advanced or Metastatic Adenocarcinoma of the Stomach
Official Title
Phase II Study of Docetaxel and Epirubicine as First-Line Treatment in Patients With Advanced or Metastatic Adenocarcinoma of the Stomach
Study Type
Interventional

2. Study Status

Record Verification Date
July 2007
Overall Recruitment Status
Unknown status
Study Start Date
April 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
GERCOR - Multidisciplinary Oncology Cooperative Group

4. Oversight

5. Study Description

Brief 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. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
adenocarcinoma of the stomach, stage III gastric cancer, stage IV gastric cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
docetaxel
Intervention Type
Drug
Intervention Name(s)
epirubicin hydrochloride
Primary Outcome Measure Information:
Title
Objective tumor response rate
Title
Time to tumor progression
Secondary Outcome Measure Information:
Title
Survival without local relapse
Title
Overall survival
Title
Tolerability

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christophe Louvet, MD, PhD
Organizational Affiliation
Hopital Saint Antoine
Facility Information:
Facility Name
Centre Paul Papin
City
Angers
ZIP/Postal Code
49036
Country
France
Facility Name
Centre Hospitalier Victor Dupouy
City
Argenteuil
ZIP/Postal Code
95107
Country
France
Facility Name
Centre Hospital General Robert Ballanger
City
Aulnay Sous Bois
ZIP/Postal Code
93602
Country
France
Facility Name
C.H.G. Beauvais
City
Beauvais
ZIP/Postal Code
60021
Country
France
Facility Name
Clinique Tivoli
City
Bordeaux
ZIP/Postal Code
F-33000
Country
France
Facility Name
Hopital Louis Pasteur
City
Chartres
ZIP/Postal Code
28018
Country
France
Facility Name
Hopital Drevon
City
Dijon
ZIP/Postal Code
21000
Country
France
Facility Name
Clinique Sainte-Marguerite
City
Hyeres
ZIP/Postal Code
83400
Country
France
Facility Name
Clinique Victor Hugo
City
Le Mans
ZIP/Postal Code
F-72000
Country
France
Facility Name
Centre Hospital Universitaire Hop Huriez
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Clinique Saint Jean
City
Lyon
ZIP/Postal Code
69008
Country
France
Facility Name
Hopital de la Croix Rousse
City
Lyon
ZIP/Postal Code
69317
Country
France
Facility Name
CHU de la Timone
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
Intercommunal Hospital
City
Montfermeil
ZIP/Postal Code
93370
Country
France
Facility Name
American Hospital of Paris
City
Neuilly Sur Seine
ZIP/Postal Code
F-92202
Country
France
Facility Name
Hopital Saint Antoine
City
Paris
ZIP/Postal Code
75571
Country
France
Facility Name
Hopital Saint Joseph
City
Paris
ZIP/Postal Code
75674
Country
France
Facility Name
Hopital Tenon
City
Paris
ZIP/Postal Code
75970
Country
France
Facility Name
Maison Medicale Marzet
City
Pau
ZIP/Postal Code
64000
Country
France
Facility Name
Hopital Rene Dubos
City
Pontoise
ZIP/Postal Code
95300
Country
France
Facility Name
C.H. Senlis
City
Senlis
ZIP/Postal Code
60309
Country
France
Facility Name
Hopital d'Instruction des Armes Sainte-Anne
City
Toulon
ZIP/Postal Code
83800
Country
France
Facility Name
CHRU de Tours - Hopital Trousseau
City
Tours
ZIP/Postal Code
37044
Country
France

12. IPD Sharing Statement

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

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