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Study of Vinorelbine and Cyclofosfamide Among Patients With Refractory Tumours or in Relapse

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2006 by Gustave Roussy, Cancer Campus, Grand Paris.
Recruitment status was:  Recruiting
Information provided by:
Gustave Roussy, Cancer Campus, Grand Paris Identifier:
First received: September 13, 2005
Last updated: September 7, 2006
Last verified: September 2006
This is a phase II study to determine the antitumor activity of Vinorelbine and Cyclofosfamide association among patients with refractory tumours or in relapse with rhabdomyosarcomas and other soft tissue tumours, Ewing tumours, osteosarcomas, neuroblastomas or medulloblastomas.

Condition Intervention Phase
Neoplasms, Connective and Soft Tissue
Ewing Tumor
Drug: Vinorelbine, cyclofosfamide
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Vinorelbine + Cyclofosfamide Association Among Patients Reached of Refractory Tumours or in Relapse

Resource links provided by NLM:

Further study details as provided by Gustave Roussy, Cancer Campus, Grand Paris:

Primary Outcome Measures:
  • To determine the antitumor activity of Vinorelbine and oral Cyclofosfamide association in refractory tumours or in relapse

Secondary Outcome Measures:
  • To evaluate the hematologic tolerance of this association
  • To evaluate the pharmacokinetics of injectable Vinorelbine

Estimated Enrollment: 210
Study Start Date: June 2003

Ages Eligible for Study:   12 Months to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age > 12 months and < 25 years
  • 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:

  • Does not satisfy the criteria of eligibility
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00180947

Institut Gustave-Roussy
Villejuif, France, 94800
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
Principal Investigator: Odile OBERLIN, MD Gustave Roussy, Cancer Campus, Grand Paris
  More Information Identifier: NCT00180947     History of Changes
Other Study ID Numbers: NAVE-CYCLO 
Study First Received: September 13, 2005
Last Updated: September 7, 2006

Keywords provided by Gustave Roussy, Cancer Campus, Grand Paris:
Soft parts tissue

Additional relevant MeSH terms:
Neoplasms, Connective and Soft Tissue
Sarcoma, Ewing
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Muscle Tissue
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action processed this record on February 20, 2017