Phase II Study of Chemotherapy and Pamidronate for the Treatment of Newly Diagnosed Osteosarcoma

NCT00586846 | Completed Phase 2 Results

• 1 other identifier: 03-074
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to test the safety and feasibility of the simultaneous administration of a biphosphonate with chemotherapy for the treatment of osteosarcoma in newly diagnosed patients.

Conditions

Osteosarcoma

Keywords

Cisplatin; Doxorubicin; Methotrexate; Osteosarcoma; 03-074

Outcome Measures

Primary Outcomes (1)

• Radiographic Response

  to the induction chemotherapy in the primary tumor and in any metastatic lesions using the Response Evaluation Criteria (RECIST).

  2 years

Study Arms (1)

1

EXPERIMENTAL

Drug: Cisplatin; Drug: Doxorubicin; Drug: Methotrexate

Interventions

Cisplatin DRUG

Cisplatin 120 mg/m\^2

1

Doxorubicin DRUG

75mg/m\^2

1

Methotrexate DRUG

Methotrexate 12g/m\^2

1

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Newly diagnosed, previously untreated biopsy proven high-grade osteosarcoma. Patient who have undergone a definitive surgical resection as their primary surgery are still eligible for participation in this study.
• No prior chemotherapy or radiation therapy
• Adequate renal function: creatinine \< or = to 1.5 upper limit of normal
• Adequate liver function as defined by bilirubin \< or = to 1.5 X upper limit of normal and AST \< or = to 3 X upper limit of normal institutional range Adequate hematopoietic function as defined by platelet count \> or = to 100,000/ram3 an absolute neutrophil count \> or = to 1,000/mm3.
• Adequate cardiac function as defined by shortening fraction \> or = to 28% by echocardiogram OR ejection fraction \> or = to 50% by radionuclide angiogram
• Performance status \< or = to 2

You may not qualify if:

• Prior history of cancer
• Prior treatment for cancer
• Prior history of Paget's disease
• Prior history of pericarditis, myocarditis, symptomatic arrhythmia or symptomatic cardiac conduction abnormalities
• Pregnancy or breast feeding

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan-Kettering Cancer Center

MeSH Terms

Conditions

Osteosarcoma

Interventions

Cisplatin; Doxorubicin; Methotrexate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Paul Meyers
• Organization: Memorial Sloan Kettering Cancer Center

meyersp@mskcc.org

212-639-5952

Study Officials

• Meyers Paul, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: January 7, 2008
• Study Start: July 1, 2003
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: January 20, 2016
• Results First Posted: January 20, 2016

Record last verified: 2015-12

Locations

US (1)