Phase II Trial for the Treatment of Relapsed Osteosarcoma (OsteoREC2015)

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ClinicalTrials.gov Identifier: NCT02718482

Recruitment Status : Terminated (Not adequate enrollment (sample size not possible to reach))

First Posted : March 24, 2016

Last Update Posted : May 13, 2019

Sponsor:

Information provided by (Responsible Party):

Italian Sarcoma Group

Study Description

Brief Summary:

Phase II randomized study for the comparison of the Gemcitabine plus Docetaxel and the Ifosfamide treatment of patients with relapsed osteosarcoma

Condition or disease	Intervention/treatment	Phase
OSTEOSARCOMA	Drug: Gemcitabine and Docetaxel Drug: Ifosfamide	Phase 2

Detailed Description:

Patients with relapsed osteosarcoma will be randomized to receive Gemcitabine plus Docetaxel or High Doses Ifosfamide (continuous infusion) every 3 weeks, up to 6 weeks

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	7 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Multicentric, Randomized Phase II Trial for the Treatment of Patients With Relapsed Osteosarcoma
Actual Study Start Date :	April 6, 2016
Actual Primary Completion Date :	January 7, 2019
Actual Study Completion Date :	January 7, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Ifosfamide Gemcitabine Docetaxel Gemcitabine hydrochloride

Genetic and Rare Diseases Information Center resources: Osteosarcoma Soft Tissue Sarcoma

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Gemcitabine and Docetaxel Gemcitabine i.v. 900 mg/m2 in 30 min on day 1 and day 8 every 3 weeks Docetaxel i.v. 75 mg/m2 in 60 min on day 8 every 3 weeks	Drug: Gemcitabine and Docetaxel Treatment with gemcitabine and docetaxel at day 1 and day 8 n a 3 weeks cycle
Experimental: Ifosfamide Ifosfamide i.v. 14 g/m2 continous dose for 14 days every 3 weeks	Drug: Ifosfamide Treatment arm with high doses of ifosfamide continous infusion for 14 days in a 3 weeks cycle Other Name: High doses ifosfamide

Outcome Measures

Primary Outcome Measures :

Progression Free Survival [ Time Frame: at 6 months from randomization ]
Survival without progression of disease assessed at 6 months from randomization

Secondary Outcome Measures :

Overall Response Rate [ Time Frame: After 6, 12 and 18 weeks ]
Rate of tumor response assessed after cycle 2, 4 and 6
Overall Survival [ Time Frame: At patient death or at last available follow-up ]
From date of starting therapy until the date of death from any cause, whichever came first, assessed up to 60 months
Post treatment Surgery Rate [ Time Frame: After 6, 12 and 18 weeks ]
Rate of patients who will require surgery after 2, 4 and 6 study treatment cycles
Adverse Events Incidence [ Time Frame: Every 3 weeks up to 22 weeks ]
Number and grade of adverse events related to the study treatments
Quality of life assesment: data will be collected by using specific oncologic Quality of Life instruments [ Time Frame: After 6, 12 and 18 weeks and at 12 Months after end of treatment ]
Quality of Life evaluation related to received chemotherapy
Duration of hospitalization [ Time Frame: After 1,3, 4, 6, 7, 9, 10, 12, 13, 15, 16 and 18 weeks ]
Number of days spent in hospital related to treatment received

Eligibility Criteria

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Ages Eligible for Study:	4 Years and older (Child, Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of high grade osteosarcoma recurrence
Resectable or unresectable recurrence disease within 24 months from the initial diagnosis
Pleuro-pulmonary recurrence with more than 2 nodules within 24 months from the initial diagnosis
Unresectable first relapse within 24 months from the initial diagnosis
Resectable or unresectable second of further recurrence of high grade osteosarcoma
Age at diagnosis at least 4years.
Karnofsky performance status over 60%.
Renal function and hepatic In normal limits for age.
L eft ejection ventricular fraction over 50%.
White blood cells over 3000 million/liter and platelets 100000 million/liter
Birth potential female must agreed to contraception
Signed written informed consent

Exclusion Criteria:

Contraindication to the use of any study drugs
Mental, social and geographic conditions which fail to ensure adequate adherence to the study
Hepatitis and human immunodeficiency virus active infection
Pregnancy or breast-feeding
Previous treatment with Gemcitabine, Docetaxel and Ifosfamide

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02718482

Locations

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Italy
Fondazione del Piemonte per l'Oncologia IRCC Candiolo
Candiolo, Torino, Italy, 10060
Ospedale Gradenigo
Torino, TO, Italy, 10153
Istituti Ortopedici Rizzoli - Unit of Chemotherapy of Muscoloskeletal Tumors
Bologna, Italy, 40136
A.O. Universitaria Meyer
Firenze, Italy, 50139
Istituto Giannina Gaslini
Genova, Italy
FONDAZIONE IRCCS Istituto Nazionale dei Tumori
Milano, Italy
Università seconda di Napoli
Napoli, Italy, 80100
Azienda Ospedaliera di Padova
Padova, Italy
Istituto Regina Elena - IFO
Rome, Italy, 00100
Ospedale Infantile Regina Margherita - Unit of Paediatric Oncoematology
Torino, Italy, 10126

Sponsors and Collaborators

Italian Sarcoma Group

Investigators

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Principal Investigator:	Stefano Ferrari, MD	Istituto Ortopedico Rizzoli

More Information

Publications:

Saeter G, Høie J, Stenwig AE, Johansson AK, Hannisdal E, Solheim OP. Systemic relapse of patients with osteogenic sarcoma. Prognostic factors for long term survival. Cancer. 1995 Mar 1;75(5):1084-93.

Bacci G, Briccoli A, Ferrari S, Ruggieri P, Avella M, Casadei R, Battistini A, Picci P. [Osteosarcoma of the extremities metastatic at presentation. Results obtained with primary chemotherapy followed by simultaneous resection of the primary and metastatic lesion]. Minerva Chir. 1993 Jan;48(1-2):35-45. Italian.

Bielack SS, Kempf-Bielack B, Delling G, Exner GU, Flege S, Helmke K, Kotz R, Salzer-Kuntschik M, Werner M, Winkelmann W, Zoubek A, Jürgens H, Winkler K. Prognostic factors in high-grade osteosarcoma of the extremities or trunk: an analysis of 1,702 patients treated on neoadjuvant cooperative osteosarcoma study group protocols. J Clin Oncol. 2002 Feb 1;20(3):776-90.

Meazza C, Casanova M, Luksch R, Podda M, Favini F, Cefalo G, Massimino M, Ferrari A. Prolonged 14-day continuous infusion of high-dose ifosfamide with an external portable pump: feasibility and efficacy in refractory pediatric sarcoma. Pediatr Blood Cancer. 2010 Oct;55(4):617-20. doi: 10.1002/pbc.22596.

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Responsible Party:	Italian Sarcoma Group
ClinicalTrials.gov Identifier:	NCT02718482
Other Study ID Numbers:	OsteoREC2015
First Posted:	March 24, 2016 Key Record Dates
Last Update Posted:	May 13, 2019
Last Verified:	May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Yes

Additional relevant MeSH terms:

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Osteosarcoma Neoplasms, Bone Tissue Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Sarcoma Gemcitabine Docetaxel Ifosfamide Isophosphamide mustard Antimetabolites, Antineoplastic Antimetabolites	Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Tubulin Modulators Antimitotic Agents Mitosis Modulators Antineoplastic Agents, Alkylating Alkylating Agents

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