Combination Chemotherapy With or Without Zoledronic Acid in Treating Patients With Osteosarcoma - Full Text View

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 III

MedlinePlus related topics:

Cancer Soft Tissue Sarcoma

ChemIDplus related topics:

Doxorubicin Doxorubicin hydrochloride Ifosfamide Etoposide Cisplatin Methotrexate Etoposide phosphate Zoledronic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized

Official Title:	Zoledronate-Ostéosarcome Protocole de Traitement Des ostéosarcomes de l'Enfant, de l'Adolescent et de l'Adulte Comportant

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00470223

Locations


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

Sponsors and Collaborators

Federation Nationale des Centres de Lutte Contre le Cancer

Investigators


Study Chair:	Laurence Brugieres, MD	Institut Gustave Roussy

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

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
First Received:	May 3, 2007
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00470223
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

localized osteosarcoma

metastatic osteosarcoma

Study placed in the following topic categories:

Zoledronic acid

Malignant mesenchymal tumor

Osteosarcoma

Osteogenic sarcoma

Etoposide phosphate

Soft tissue sarcomas

Doxorubicin

Folic Acid

Neoplasms, Connective and Soft Tissue

Ifosfamide

Cisplatin

Sarcoma

Methotrexate

Etoposide

Isophosphamide mustard

Additional relevant MeSH terms:

Antimetabolites

Antimetabolites, Antineoplastic

Molecular Mechanisms of Pharmacological Action

Immunologic Factors

Antineoplastic Agents

Physiological Effects of Drugs

Bone Density Conservation Agents

Reproductive Control Agents

Antibiotics, Antineoplastic

Therapeutic Uses

Abortifacient Agents

Alkylating Agents

Dermatologic Agents

Nucleic Acid Synthesis Inhibitors

Neoplasms by Histologic Type

Enzyme Inhibitors

Abortifacient Agents, Nonsteroidal

Folic Acid Antagonists

Immunosuppressive Agents

Pharmacologic Actions

Neoplasms

Neoplasms, Bone Tissue

Antineoplastic Agents, Alkylating

Neoplasms, Connective Tissue

Antirheumatic Agents

ClinicalTrials.gov processed this record on September 23, 2008

Sponsored by:	Federation Nationale des Centres de Lutte Contre le Cancer
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00470223