- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00023998
Chemotherapy With or Without Trastuzumab in Treating Patients With Metastatic Osteosarcoma
A Groupwide Phase II Study of Trastuzumab (Herceptin) in Metastatic Osteosarcoma Patients With Tumors That Overexpress HER2
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
PRIMARY OBJECTIVES:
I. Determine the feasibility and safety of trastuzumab (Herceptin) and chemotherapy in patients with HER2-overexpressing (2+ level of expression) metastatic osteosarcoma.
II. Determine the response rate and 3-year event-free survival of patients treated with this regimen.
III. Determine the cardiac toxicity and late effects of this regimen in these patients.
IV. Determine the response rate and 3-year event-free survival of poor-risk patients with HER2-negative tumors treated with chemotherapy without the addition of trastuzumab.
OUTLINE: This is a multicenter study. Patients are stratified according to tumor HER2 status (positive vs negative).
Patients receive induction therapy comprising doxorubicin IV over 20 minutes followed by cisplatin IV over 4 hours on days 1 and 2 of weeks 1 and 6, and methotrexate IV over 4 hours on day 1 of weeks 4, 5, 9, and 10. Patients also receive leucovorin calcium IV or orally every 6 hours beginning 24 hours after each methotrexate dose and continuing for at least 10 doses until methotrexate levels sufficiently decrease. Within 24-36 hours after completion of induction therapy, patients receive filgrastim (G-CSF) daily until blood counts recover.
Patients undergo resection of any remaining primary tumor and/or metastatic lesions during week 11. Patients who are unable to undergo resection receive radiotherapy between weeks 11 and 17.
Patients receive post-induction therapy comprising doxorubicin IV over 20 minutes on days 1 and 2 of weeks 17, 25, and 29; cisplatin IV over 4 hours on days 1 and 2 of weeks 17 and 25; methotrexate IV over 4 hours on day 1 of weeks 16, 20, 24, 28, 32, and 33; etoposide IV over 1 hour on days 1-5 of weeks 13, 21, and 34; and ifosfamide IV over 4 hours on days 1-5 of weeks 13, 21, 29, and 34. Patients also receive leucovorin calcium and G-CSF as in induction therapy. Patients whose tumors are found to over express HER2 (2+ level of expression) also receive trastuzumab IV over 30-90 minutes once a week for a total of 34 weeks in addition to the chemotherapy regimen.
Patients are followed monthly for 1 year, every 2 months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 80 patients (40 patients per stratum) will be accrued for this study within 2.5 years.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
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California
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Arcadia, California, Forenede Stater, 91006-3776
- Children's Oncology Group
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
Histologically confirmed high-grade osteosarcoma
- Metastatic
- Newly diagnosed
- No osteosarcoma arising in areas of Paget's disease or radiotherapy-induced sarcoma
Presenting with at least 1 of the following:
- Bone metastases with or without lung metastases
- Bilateral lung metastases (any number of nodules)
- Unilateral lung metastases with at least 4 nodules
- Planned resection of either the primary site or a metastatic site of disease after completion of induction therapy
- Must be currently enrolled on the tumor biology study COG-P9851
- Performance status - ECOG 0-2
- Performance status - Karnofsky 50-100% (over age 10)
- Performance status - Lansky 50-100% (age 10 and under)
- Absolute neutrophil count > 1,000/mm^3
- Platelet count > 100,000/mm^3
- Bilirubin ≤ 1.5 times normal
- SGPT ≤ 3 times normal
- Creatinine ≤ 1.5 times normal
- Creatinine clearance or glomerular filtration rate ≥ 70 mL/min
- Shortening fraction ≥ 28% by echocardiogram
- Ejection fraction ≥ 50% by echocardiogram or MUGA
- No history of pericarditis, myocarditis, symptomatic arrhythmia, or conduction disturbances
- Normal organ function
- HIV negative
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No prior chemotherapy
- No prior radiotherapy
- See Disease Characteristics
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Treatment (combination chemotherapy)
See detailed description.
|
Korrelative undersøgelser
Givet IV
Andre navne:
Givet IV
Andre navne:
Givet IV
Andre navne:
Gennemgå strålebehandling
Andre navne:
Givet IV
Andre navne:
Givet IV
Andre navne:
Gives IV eller oralt
Andre navne:
Givet IV
Andre navne:
Givet IV
Andre navne:
Gennemgå resektion
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Feasibility and safety of treatment assessed using CTC version 2.0
Tidsramme: Up to 6 years
|
Descriptive statistics will be utilized to assess feasibility and safety.
All toxicities will be carefully monitored.
A detailed tabulation of observed toxicities will be made and a qualitative decision on the feasibility will be made.
|
Up to 6 years
|
Response rate
Tidsramme: Up to 6 years
|
Will be estimated with a maximum standard error of no more than 8%.
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Up to 6 years
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Event free survival (EFS)
Tidsramme: 3 years
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Will be estimated by the Kaplan-Meier method with a maximum standard error of 8%.
|
3 years
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: David Ebb, Children's Oncology Group
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Neoplasmer, bindevæv og blødt væv
- Neoplasmer efter histologisk type
- Neoplasmer
- Neoplasmer, Knoglevæv
- Neoplasmer, bindevæv
- Sarkom
- Osteosarkom
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Nukleinsyresyntesehæmmere
- Enzymhæmmere
- Antirheumatiske midler
- Antimetabolitter, Antineoplastisk
- Antimetabolitter
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Beskyttelsesagenter
- Antineoplastiske midler, Alkylering
- Alkyleringsmidler
- Antineoplastiske midler, fytogene
- Topoisomerase II-hæmmere
- Topoisomerasehæmmere
- Antineoplastiske midler, immunologiske
- Dermatologiske midler
- Mikronæringsstoffer
- Antibiotika, antineoplastisk
- Vitaminer
- Reproduktive kontrolmidler
- Modgift
- Vitamin B kompleks
- Abortfremkaldende midler, ikke-steroide
- Aborterende midler
- Folinsyreantagonister
- Etoposid
- Etoposid fosfat
- Trastuzumab
- Ifosfamid
- Leucovorin
- Levoleucovorin
- Doxorubicin
- Liposomal doxorubicin
- Methotrexat
Andre undersøgelses-id-numre
- NCI-2012-01863
- U10CA098543 (U.S. NIH-bevilling/kontrakt)
- AOST0121
- CDR0000068882 (Registry Identifier: PDQ (Physician Data Query))
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Metastatisk osteosarkom
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Children's Oncology GroupNational Cancer Institute (NCI)AfsluttetTilbagevendende osteosarkom | Ildfast osteosarkom | Stage IV osteosarkom AJCC v7 | Stage IVA Osteosarcoma AJCC v7 | Stage IVB Osteosarcoma AJCC v7 | Metastatisk osteosarkomForenede Stater, Canada, Puerto Rico
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Association Pour La Recherche des Thérapeutiques...AfsluttetClear Cell Metastatic Renal Cell CarcinomaFrankrig
-
National Cancer Institute (NCI)Aktiv, ikke rekrutterendeTilbagevendende Ewing-sarkom | Tilbagevendende osteosarkom | Stage III osteosarkom AJCC v7 | Stage IV osteosarkom AJCC v7 | Stage IVA Osteosarcoma AJCC v7 | Stage IVB Osteosarcoma AJCC v7 | Metastatisk osteosarkom | Metastatisk Ewing-sarkom | Uoperabelt Ewing-sarkom | Uoperabelt osteosarkomFrankrig
-
Sunnybrook Health Sciences CentrePfizerAfsluttetClear Cell Metastatic Renal Cell CarcinomaCanada
-
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-
National Cancer Institute (NCI)RekrutteringOndartet gliom | Rhabdoid tumor | Avanceret malignt fast neoplasma | Ildfast malignt fast neoplasma | Tilbagevendende Ependymom | Tilbagevendende Ewing-sarkom | Tilbagevendende hepatoblastom | Tilbagevendende Langerhans Cell Histiocytose | Tilbagevendende ondartet kimcelletumor | Tilbagevendende malignt fast... og andre forholdForenede Stater, Puerto Rico, Australien, Canada
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