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

Sponsor:

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

History of Changes

Tracking Information

First Received Date ^ICMJE

January 9, 2004

Last Updated Date

July 23, 2008

Start Date ^ICMJE

April 2001

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Objective tumor response rate [ Designated as safety issue: No ]
Time to tumor progression [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00075465 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Survival without local relapse [ Designated as safety issue: No ]
Overall survival [ Designated as safety issue: No ]
Tolerability [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Gastric Cancer

Intervention ^ICMJE

Drug: docetaxel
Drug: epirubicin hydrochloride

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Not Provided

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT00075465

Other Study ID Numbers ^ICMJE

CDR0000346617, FRE-GERCOR-EPITAXD00-1, EU-20326

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Investigator:

Christophe Louvet, MD, PhD

Hopital Saint Antoine

Information Provided By

National Cancer Institute (NCI)

Verification Date

July 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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