Combination Chemotherapy With or Without Zoledronic Acid in Treating Patients With Osteosarcoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2007 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00470223
First received: May 3, 2007
Last updated: February 6, 2009
Last verified: May 2007
  Purpose

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Zoledronic acid may stop the growth of tumor cells in bone. Giving chemotherapy with or without zoledronic acid before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments after surgery may kill any tumor cells that remain after surgery. It is not yet known whether giving combination chemotherapy together with zoledronic acid is more effective than combination chemotherapy alone in treating osteosarcoma.

PURPOSE: This randomized phase III trial is studying combination chemotherapy and zoledronic acid to see how well they work compared with combination chemotherapy alone in treating patients with osteosarcoma.


Condition Intervention Phase
Sarcoma
Drug: cisplatin
Drug: doxorubicin hydrochloride
Drug: etoposide
Drug: ifosfamide
Drug: methotrexate
Drug: zoledronic acid
Procedure: conventional surgery
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: Zoledronate-Ostéosarcome Protocole de Traitement Des ostéosarcomes de l'Enfant, de l'Adolescent et de l'Adulte Comportant

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Progression-free survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Designated as safety issue: No ]
  • Percentage of good responders [ Designated as safety issue: No ]
  • Short term and long term toxicity [ Designated as safety issue: Yes ]
  • Quality of life [ Designated as safety issue: No ]

Estimated Enrollment: 440
Study Start Date: March 2007
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   5 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed high-grade osteosarcoma
  • The following are excluded:

    • Low-grade osteosarcoma
    • Small cell osteosarcoma
    • Maxillary osteosarcoma
    • Primary resected osteosarcoma
    • Osteosarcoma with multiple metastases for which complete removal is not feasible even after shrinkage with chemotherapy
    • Extra-osseous osteosarcoma
    • Any prior osteonecrosis of the maxilla

PATIENT CHARACTERISTICS:

  • Bilirubin ≤ 2 times upper limit of normal
  • No medical condition that would preclude study treatment
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • Shortening fraction ≥ 28%
  • LVEF ≥ 50%
  • Glomerular filtration rate ≥ 70mL/min
  • No recent dental problem, including infection, traumatization, or surgery

PRIOR CONCURRENT THERAPY:

  • No prior chemotherapy or radiotherapy
  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 ClinicalTrials.gov identifier: NCT00470223

Locations
France
Institut Gustave Roussy Recruiting
Angers, France, 49036
Contact: Contact Person    33-1-4211-4339      
Centre Paul Papin Recruiting
Angers, France, 49036
Contact: Contact Person    33-2-4135-270      
CHR de Besancon - Hopital Saint-Jacques Recruiting
Besancon, France, 25030
Contact: Contact Person    33-381-668-240      
Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz Recruiting
Besancon, France, 25030
Contact: Loic Chaigneau    33-81-668-240      
Institut Bergonie Recruiting
Bordeaux, France, 33076
Contact: Nguyen Binh Bui, MD    33-556-333-333      
CHU Hopital A. Morvan Recruiting
Brest, France, 29609
Contact: Contact Person    33-298-223-395      
CHU de Caen Recruiting
Caen, France, 14033
Contact: Patrick Boutard, MD    33-231-064-488    boutard_p@chu-caen.fr   
Centre Regional Francois Baclesse Recruiting
Caen, France, 14076
Contact: Corinne Delcambre    33-2-3145-5000      
Centre Jean Perrin Recruiting
Clermont-Ferrand, France, 63011
Contact: Jacques-Olivier Bay, MD, PhD    33-73-278-080      
CHR Clermont Ferrand, Hotel Dieu Recruiting
Clermont-Ferrand, France, 63003
Contact: Contact Person    33-73-316-000      
Centre de Lutte Contre le Cancer Georges-Francois Leclerc Recruiting
Dijon, France, 21079
Contact: Nicolas Isambert, MD    33-3-8073-7506      
Centre Hospitalier Universitaire de Dijon Recruiting
Dijon, France, 21079
Contact: G. Couillault    33-380-293-031      
CHU de Grenoble - Hopital Michallon Recruiting
Grenoble, France, 38043
Contact: Contact Person    33-4-7676-5028      
Centre Oscar Lambret Recruiting
Lille, France, 59020
Contact: Contact Person    33-20-29-5959      
Centre Leon Berard Recruiting
Lyon, France, 69373
Contact: Contact Person    33-4-78-78-26-45      
Hopital Edouard Herriot - Lyon Recruiting
Lyon, France, 69437
Contact: Jean-Yves Blay, MD, PhD    33-47-211-7398    jy.blay@chu-lyon.fr   
CHU Nord Recruiting
Marseille, France, 13915
Contact: Brigitte Pautard, MD    33-3-2266-8950      
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes Recruiting
Marseille, France, 13273
Contact: Francois Bertucci, MD    33-4-9122-3537      
Hopital d'Enfants de la Timone Recruiting
Marseille, France, 13385
Contact: Jean-Claude Gentet, MD    33-04-91-386-821    jean-claude.gentet@ap-hm.fr   
CHU de la Timone Recruiting
Marseille, France, 13385
Contact: Florence Duffaud, MD    33-4-9138-5708    fduffaud@mail.ap-hm.fr   
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle Recruiting
Montpellier, France, 34298
Contact: Didier Cupissol, MD, PhD    33-4-6761-3100    dcupissol@valdorel.fnclcc.fr   
Hopital Arnaud de Villeneuve Recruiting
Montpellier, France, 34295
Contact: Contact Person    33-67-336-630      
Centre Regional Rene Gauducheau Recruiting
Nantes-Saint Herblain, France, 44805
Contact: Emmanuelle Bompas    33-2-40-479-959      
Centre Antoine Lacassagne Recruiting
Nice, France, 06189
Contact: Antoine Thyss, MD    33-04-9203-1538    antoine.thyss@cal.nice.fnclcc.fr   
Hopital de l'Archet CHU de Nice Recruiting
Nice, France, F-06202
Contact: Contact Person    33-49-203-9267      
Institut Curie Hopital Recruiting
Paris, France, 75248
Contact: Sophie Piperno-Neumann, MD    33-44-32-4000      
Hopital Jean Bernard Recruiting
Poitiers, France, 86021
Contact: Frederic Millot, MD    33-05-49-444-201    f.millot@chu-poitiers.fr   
Centre Eugene Marquis Recruiting
Rennes, France, 35042
Contact: Pierre Kerbrat, MD, PhD    33-299-253-280    kerbrat@rennes.fnclcc.fr   
Hopital Charles Nicolle Recruiting
Rouen, France, 76031
Contact: J.P. Vannier    33-2-3288-89-90      
Centre Henri Becquerel Recruiting
Rouen, France, 76038
Contact: Cecile Guillemet, MD    33-02-32-02-2237    cecile.guillemet@rouen.fnclcc.fr   
Institut de Cancerologie de la Loire Recruiting
Saint Priest en Jarez, France, 42270
Contact: Contact Person    33-477-91-7000      
Hopitaux Universitaire de Strasbourg Recruiting
Strasbourg, France, 67091
Contact: Contact Person    33-388-116-768      
Hopital Universitaire Hautepierre Recruiting
Strasbourg, France, 67098
Contact: Patrick Lutz, MD    33-388-127-682      
Hopital des Enfants Recruiting
Toulouse, France, 31059
Contact: Herve Rubie, MD    33-53-455-8611      
CHRU de Tours - Hopital Trousseau Recruiting
Tours, France, 37044
Contact: Contact Person    33-2-4747-4603      
C.H. Bastien de Clocheville Recruiting
Tours, France, 3700
Contact: Contact Person    33-02-4747-4747      
Centre Alexis Vautrin Recruiting
Vandoeuvre-les-Nancy, France, 54511
Contact: Maria Rios, MD    33-3-8359-8461    m.rios@nancy.fnclcc.fr   
Sponsors and Collaborators
UNICANCER
Investigators
Study Chair: Laurence Brugieres, MD Gustave Roussy, Cancer Campus, Grand Paris
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00470223     History of Changes
Other Study ID Numbers: CDR0000543987, FRE-FNCLCC-SARCOME-09-0603, FRE-FNCLCC-OS-2006, NOVARTIS-FRE-FNCLCC-SARCOME-09, CHUGAI-FRE-FNCLCC-SARCOME-09-0, EU-20729, EUDRACT-2006-00337727
Study First Received: May 3, 2007
Last Updated: February 6, 2009
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
localized osteosarcoma
metastatic osteosarcoma

Additional relevant MeSH terms:
Osteosarcoma
Sarcoma
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Isophosphamide mustard
Cisplatin
Doxorubicin
Etoposide
Ifosfamide
Methotrexate
Zoledronic acid
Diphosphonates
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Antineoplastic Agents, Phytogenic
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Antimetabolites, Antineoplastic
Antimetabolites

ClinicalTrials.gov processed this record on July 23, 2014