Combination Chemotherapy Before and After Surgery in Treating Patients With Osteosarcoma

NCT00019864 | Terminated Phase 2

• 2 other identifiers: CDR0000067263NCI-99-C-0125I
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 4

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy before surgery may shrink the tumor so that it can be removed during surgery. Giving chemotherapy after surgery may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving chemotherapy before and after surgery works in treating patients with osteosarcoma.

Conditions

Cardiac Toxicity; Sarcoma

Keywords

cardiac toxicity; localized osteosarcoma; metastatic osteosarcoma; recurrent osteosarcoma

Outcome Measures

Primary Outcomes (3)

• Rate of in vivo histologic response

• Event-free survival

• Overall survival

Interventions

filgrastim BIOLOGICAL

cisplatin DRUG

dexrazoxane hydrochloride DRUG

doxorubicin hydrochloride DRUG

leucovorin calcium DRUG

methotrexate DRUG

adjuvant therapy PROCEDURE

conventional surgery PROCEDURE

neoadjuvant therapy PROCEDURE

Eligibility Criteria

• Age: Up to 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

DISEASE CHARACTERISTICS: * Histologically confirmed newly diagnosed osteosarcoma * No more than 1 month since prior diagnostic biopsy * Nonmetastatic malignant high-grade osteosarcoma of bone * Histologically confirmed metastatic disease allowed * Unresectable primary disease allowed * No low-grade, parosteal, or periosteal osteosarcoma PATIENT CHARACTERISTICS: Age: * 25 and under Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count at least 1,000/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 8.0 g/dL Hepatic: * Bilirubin no greater than 2.0 mg/dL * ALT less than 5 times normal Renal: * Creatinine no greater than 1.5 times normal * Creatinine clearance or radioisotope glomerular filtration rate greater than 70 mL/min Cardiovascular: * Shortening fraction at least 27% by echocardiogram or MUGA * Ejection fraction at least 45% by echocardiogram or MUGA Other: * Not pregnant * Negative pregnancy test * Fertile patients must use effective contraception during and for 6 months after study PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * See Disease Characteristics * No other concurrent chemotherapy Endocrine therapy: * Not specified Radiotherapy: * See Disease Characteristics Surgery: * Not specified Other: * No other concurrent therapy with no evidence of progressive disease

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (4)

Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office

Bethesda, Maryland, 20892-1182, United States

Location

Oklahoma University Cancer Institute

Oklahoma City, Oklahoma, 73104, United States

Location

Cook Children's Medical Center - Fort Worth

Fort Worth, Texas, 76104, United States

Location

Texas Children's Cancer Center and Hematology Service at Texas Children's Hospital

Houston, Texas, 77030-2399, United States

Location

MeSH Terms

Conditions

Cardiotoxicity; Sarcoma; Osteosarcoma

Interventions

Filgrastim; Cisplatin; Dexrazoxane; Doxorubicin; Leucovorin; Methotrexate; Chemotherapy, Adjuvant; Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Razoxane; Diketopiperazines; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Aminopterin; Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Ramzi Dagher, MD

  National Cancer Institute (NCI)

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: July 11, 2001
• First Posted: January 27, 2003
• Study Start: March 1, 2000
• Primary Completion: December 1, 2006
• Study Completion: October 1, 2011
• Last Updated: June 8, 2015

Record last verified: 2007-10

Locations

US (4)