Study of Vinorelbine and Cyclofosfamide Among Patients With Refractory Tumours or in Relapse
NCT ID: NCT00180947
Last Updated: 2006-09-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
210 participants
INTERVENTIONAL
2003-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Vinorelbine, cyclofosfamide
Eligibility Criteria
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Inclusion Criteria
* Measurable disease
* Score of Lansky \> 30 or World Health Organization (WHO) score \< 2
* Life expectancy \> 2 months
* Satisfactory hematologic conditions:
* Polynuclear neutrophiles \> 1 X 10\^9/l.
* Platelets \> 100 X 10\^9/l or \> 50 X 10\^9 in the event of medullary invasion.
* Creatinine \< 1.5 of normal for age or clearance \> 70 ml/min/1.73 m2
* Normal hepatic function:
* Bilirubin \< 3 N
* ASAT and ALAT \< 2,5 N).
* Absence of toxicity of bodies (Rank \> 2 according to coding National Cancer Institute-Common Toxicity Criteria \[NCI-CTC\] version 2.0)
* Absence of antecedent of hematuric cystitis to repetition
* Written consent, signed by the patient or the two parents or holder(s) of the parental authority of the minor subjects
Exclusion Criteria
12 Months
25 Years
ALL
No
Sponsors
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Gustave Roussy, Cancer Campus, Grand Paris
OTHER
Principal Investigators
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Odile OBERLIN, MD
Role: PRINCIPAL_INVESTIGATOR
Gustave Roussy, Cancer Campus, Grand Paris
Locations
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Institut Gustave-Roussy
Villejuif, , France
Countries
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Central Contacts
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Facility Contacts
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Odile OBERLIN, MD
Role: primary
Annie REY
Role: backup
Other Identifiers
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NAVE-CYCLO
Identifier Type: -
Identifier Source: org_study_id