A Phase 2 interventional study of doxorubicin hydrochloride and cisplatin in Metastatic Osteosarcoma, sponsored by National Cancer Institute (NCI). Completed at 1 site in United States. Open to participants aged Up to 30 Years. Per ClinicalTrials.gov, last updated 2013-02-04.
Sponsored by National Cancer Institute (NCI) · Phase 2, Interventional, and Treatment
Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and kill them without harming normal cells. Combining monoclonal antibody therapy with chemotherapy may kill more tumor cells. Phase II trial to study the effectiveness of chemotherapy with or without trastuzumab in treating patients who have metastatic osteosarcoma
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.
437 studies on the registry are indexed under Osteosarcoma; 116 are open to participants now.
This study's enrollment of 80 is above the median of 42 across 325 interventional studies indexed under Osteosarcoma.
Browse Osteosarcoma studies →National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.
Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Histologically confirmed high-grade osteosarcoma
Presenting with at least 1 of the following:
See detailed description.
Drug: doxorubicin hydrochloride · Drug: cisplatin · Drug: methotrexate · Drug: leucovorin calcium · Biological: filgrastim · Procedure: therapeutic conventional surgery · Radiation: radiation therapy · Drug: etoposide · Drug: ifosfamide · Biological: trastuzumab · Other: laboratory biomarker analysis
Given IV
Also known as: ADM, ADR, Adria, Adriamycin PFS, Adriamycin RDF
Given IV
Also known as: CACP, CDDP, CPDD, DDP
Given IV
Also known as: amethopterin, Folex, methylaminopterin, Mexate, MTX
Given IV or orally
Also known as: CF, CFR, LV
Given IV
Also known as: G-CSF, Neupogen
Undergo resection
Undergo radiotherapy
Also known as: irradiation, radiotherapy, therapy, radiation
Given IV
Also known as: EPEG, VP-16, VP-16-213
Given IV
Also known as: Cyfos, Holoxan, IFF, IFX, IPP
Given IV
Also known as: anti-c-erB-2, Herceptin, MOAB HER2
Correlative studies
Feasibility and safety of treatment assessed using CTC version 2.0
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.
Time frame: Up to 6 years
Response rate
Will be estimated with a maximum standard error of no more than 8%.
Time frame: Up to 6 years
Event free survival (EFS)
Will be estimated by the Kaplan-Meier method with a maximum standard error of 8%.
Time frame: 3 years
This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.
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National Cancer Institute (NCI)