Clinical trial · Interventional
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
NCT00023998CI-TRIAL-00009271completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Osteosarcoma | Osteosarcoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (11)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin | Drug | Cisplatin | ALIAS |
| doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
| etoposide | Drug | Etoposide | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
| ifosfamide | Drug | Ifosfamide | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| leucovorin calcium | Drug | Leucovorin | ALIAS |
| methotrexate | Drug | Methotrexate | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (combination chemotherapy)
- description
- See detailed description.
- interventionNames
- 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
Primary outcomes (3)
- measure
- Feasibility and safety of treatment assessed using CTC version 2.0
- timeFrame
- Up to 6 years
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 30 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDKopp LM, Womer RB, Schwartz CL, Ebb DH, Franco VI, Hall D, Barkauskas DA, Krailo MD, Grier HE, Meyers PA, Wexler LH, Marina NM, Janeway KA, Gorlick R, Bernstein ML, Lipshultz SE; Children's Oncology Group. Effects of dexrazoxane on doxorubicin-related cardiotoxicity and second malignant neoplasms in children with osteosarcoma: a report from the Children's Oncology Group. Cardiooncology. 2019 Oct 28;5:15. doi: 10.1186/s40959-019-0050-9. eCollection 2019. PMID 32154021