Docetaxel and Epirubicin as First-Line Therapy in Treating Patients With Locally Advanced or Metastatic Adenocarcinoma of the Stomach
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2007 by National Cancer Institute (NCI).
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00075465
First received: January 9, 2004
Last updated: July 23, 2008
Last verified: July 2007
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Gastric Cancer |
Drug: docetaxel Drug: epirubicin hydrochloride |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study of Docetaxel and Epirubicine as First-Line Treatment in Patients With Advanced or Metastatic Adenocarcinoma of the Stomach |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Objective tumor response rate [ Designated as safety issue: No ]
- Time to tumor progression [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Survival without local relapse [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Tolerability [ Designated as safety issue: Yes ]
| Study Start Date: | April 2001 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00075465
Locations
| France | |
| Centre Paul Papin | |
| Angers, France, 49036 | |
| Centre Hospitalier Victor Dupouy | |
| Argenteuil, France, 95107 | |
| Centre Hospital General Robert Ballanger | |
| Aulnay Sous Bois, France, 93602 | |
| C.H.G. Beauvais | |
| Beauvais, France, 60021 | |
| Clinique Tivoli | |
| Bordeaux, France, F-33000 | |
| Hopital Louis Pasteur | |
| Chartres, France, 28018 | |
| Hopital Drevon | |
| Dijon, France, 21000 | |
| Clinique Sainte-Marguerite | |
| Hyeres, France, 83400 | |
| Clinique Victor Hugo | |
| Le Mans, France, F-72000 | |
| Centre Hospital Universitaire Hop Huriez | |
| Lille, France, 59037 | |
| Clinique Saint Jean | |
| Lyon, France, 69008 | |
| Hopital de la Croix Rousse | |
| Lyon, France, 69317 | |
| CHU de la Timone | |
| Marseille, France, 13385 | |
| Intercommunal Hospital | |
| Montfermeil, France, 93370 | |
| American Hospital of Paris | |
| Neuilly Sur Seine, France, F-92202 | |
| Hopital Saint Antoine | |
| Paris, France, 75571 | |
| Hopital Saint Joseph | |
| Paris, France, 75674 | |
| Hopital Tenon | |
| Paris, France, 75970 | |
| Maison Medicale Marzet | |
| Pau, France, 64000 | |
| Hopital Rene Dubos | |
| Pontoise, France, 95300 | |
| C.H. Senlis | |
| Senlis, France, 60309 | |
| Hopital d'Instruction des Armes Sainte-Anne | |
| Toulon, France, 83800 | |
| CHRU de Tours - Hopital Trousseau | |
| Tours, France, 37044 | |
Sponsors and Collaborators
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
Investigators
| Investigator: | Christophe Louvet, MD, PhD | Hopital Saint Antoine |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00075465 History of Changes |
| Other Study ID Numbers: | CDR0000346617, FRE-GERCOR-EPITAXD00-1, EU-20326 |
| Study First Received: | January 9, 2004 |
| Last Updated: | July 23, 2008 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
adenocarcinoma of the stomach stage III gastric cancer stage IV gastric cancer |
Additional relevant MeSH terms:
|
Adenocarcinoma Adenocarcinoma, Mucinous Stomach Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Cystic, Mucinous, and Serous Gastrointestinal Neoplasms Digestive System Neoplasms |
Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Stomach Diseases Epirubicin Docetaxel Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013