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

Information source: National Cancer Institute (NCI)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Gastric Cancer

Intervention: docetaxel (Drug); epirubicin hydrochloride (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)

Official(s) and/or principal investigator(s):
Christophe Louvet, MD, PhD, Affiliation: Hopital Saint Antoine

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.

Clinical Details

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

Study design: Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Objective tumor response rate

Time to tumor progression

Secondary outcome:

Survival without local relapse

Overall survival

Tolerability

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.

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

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

Locations and Contacts

Centre Paul Papin, Angers 49036, France

Centre Hospitalier Victor Dupouy, Argenteuil 95107, France

Centre Hospital General Robert Ballanger, Aulnay Sous Bois 93602, France

C.H.G. Beauvais, Beauvais 60021, France

Clinique Tivoli, Bordeaux F-33000, France

Hopital Louis Pasteur, Chartres 28018, France

Hopital Drevon, Dijon 21000, France

Clinique Sainte-Marguerite, Hyeres 83400, France

Clinique Victor Hugo, Le Mans F-72000, France

Centre Hospital Universitaire Hop Huriez, Lille 59037, France

Clinique Saint Jean, Lyon 69008, France

Hopital de la Croix Rousse, Lyon 69317, France

CHU de la Timone, Marseille 13385, France

Intercommunal Hospital, Montfermeil 93370, France

American Hospital of Paris, Neuilly Sur Seine F-92202, France

Hopital Saint Antoine, Paris 75571, France

Hopital Saint Joseph, Paris 75674, France

Hopital Tenon, Paris 75970, France

Maison Medicale Marzet, Pau 64000, France

Hopital Rene Dubos, Pontoise 95300, France

C.H. Senlis, Senlis 60309, France

Hopital d'Instruction des Armes Sainte-Anne, Toulon 83800, France

CHRU de Tours - Hopital Trousseau, Tours 37044, France

Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: April 2001
Last updated: July 23, 2008

Page last updated: August 23, 2015

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