Chemotherapy With or Without Trastuzumab in Treating Patients With Metastatic Osteosarcoma

NCT00023998 | Completed Phase 2

• 4 other identifiers: NCI-2012-01863AOST0121U10CA098543CDR0000068882
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Metastatic Osteosarcoma

Outcome Measures

Primary Outcomes (3)

• 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.

  Up to 6 years

• Response rate

  Will be estimated with a maximum standard error of no more than 8%.

  Up to 6 years

• Event free survival (EFS)

  Will be estimated by the Kaplan-Meier method with a maximum standard error of 8%.

  3 years

Study Arms (1)

Treatment (combination chemotherapy)

EXPERIMENTAL

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

Interventions

doxorubicin hydrochloride DRUG

Given IV

Also known as: ADM, ADR, Adria, Adriamycin PFS, Adriamycin RDF

Treatment (combination chemotherapy)

cisplatin DRUG

Given IV

Also known as: CACP, CDDP, CPDD, DDP

Treatment (combination chemotherapy)

methotrexate DRUG

Given IV

Also known as: amethopterin, Folex, methylaminopterin, Mexate, MTX

Treatment (combination chemotherapy)

leucovorin calcium DRUG

Given IV or orally

Also known as: CF, CFR, LV

Treatment (combination chemotherapy)

filgrastim BIOLOGICAL

Given IV

Also known as: G-CSF, Neupogen

Treatment (combination chemotherapy)

therapeutic conventional surgery PROCEDURE

Undergo resection

Treatment (combination chemotherapy)

radiation therapy RADIATION

Undergo radiotherapy

Also known as: irradiation, radiotherapy, therapy, radiation

Treatment (combination chemotherapy)

etoposide DRUG

Given IV

Also known as: EPEG, VP-16, VP-16-213

Treatment (combination chemotherapy)

ifosfamide DRUG

Given IV

Also known as: Cyfos, Holoxan, IFF, IFX, IPP

Treatment (combination chemotherapy)

trastuzumab BIOLOGICAL

Given IV

Also known as: anti-c-erB-2, Herceptin, MOAB HER2

Treatment (combination chemotherapy)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (combination chemotherapy)

Eligibility Criteria

• Age: Up to 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Children's Oncology Group

Arcadia, California, 91006-3776, United States

Location

Related Publications (1)

• Kopp 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 DERIVED

MeSH Terms

Conditions

Osteosarcoma

Interventions

Doxorubicin; Cisplatin; Methotrexate; merphos; Leucovorin; Filgrastim; Granulocyte Colony-Stimulating Factor; Radiotherapy; Radiation; Etoposide; Ifosfamide; indolepropanol phosphate; Trastuzumab

Condition Hierarchy (Ancestors)

Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Coenzymes; Enzymes and Coenzymes; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Therapeutics; Physical Phenomena; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Glucosides; Cyclophosphamide; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Oxazines; Heterocyclic Compounds, 1-Ring; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins

Study Officials

• David Ebb

  Children's Oncology Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2001
• First Posted: January 27, 2003
• Study Start: July 1, 2001
• Primary Completion: November 1, 2005
• Study Completion: May 1, 2007
• Last Updated: February 4, 2013

Record last verified: 2013-01

Locations

US (1)