NCT00019864

Combination Chemotherapy Before and After Surgery in Treating Patients With Osteosarcoma

Osteosarcoma: Outcome of Therapy Based on Histologic Response. A Collaborative Effort of the POB/NCI, Texas Children's Hospital and University of Oklahoma.

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 25 Years
• Healthy volunteers: Not accepted

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.

Detailed description

OBJECTIVES: * Determine the rate of in vivo histologic response in patients with osteosarcoma treated with neoadjuvant cisplatin, methotrexate, and doxorubicin with dexrazoxane (as cardioprotection). * Determine the event-free and overall survival of patients with nonmetastatic disease who show good response to neoadjuvant therapy and receive adjuvant therapy with the same regimen. * Determine the event-free survival of patients with nonmetastatic disease who show poor response to neoadjuvant therapy and receive adjuvant therapy with the same regimen. * Determine the event-free survival and overall survival of patients with metastatic disease who receive neoadjuvant therapy. OUTLINE: This is a multicenter study. * Neoadjuvant therapy: Patients receive neoadjuvant chemotherapy comprising dexrazoxane IV over 15 minutes, doxorubicin IV over 15 minutes, and cisplatin IV over 4 hours on days 1 and 2 in week 0. Patients also receive methotrexate IV over 4 hours followed by leucovorin calcium in weeks 3 and 4. Patients then receive filgrastim (G-CSF) subcutaneously (SC) once daily beginning 24 hours after completion of chemotherapy and continuing until blood counts recover. Treatment repeats every 5 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. * Surgical resection: Patients undergo definitive surgery in week 11. * Adjuvant therapy: Patients receive dexrazoxane, doxorubicin, cisplatin, methotrexate, and leucovorin calcium as in neoadjuvant therapy\*. Treatment repeats every 5 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. NOTE: \*Cisplatin is not administered in courses 3 and 4 of adjuvant therapy Patients are followed within 4 weeks, every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: Approximately 100 patients will be accrued for this study.

Conditions

• Cardiac Toxicity
• Sarcoma

Interventions

Type	Name	Description
BIOLOGICAL	filgrastim
DRUG	cisplatin
DRUG	dexrazoxane hydrochloride
DRUG	doxorubicin hydrochloride
DRUG	leucovorin calcium
DRUG	methotrexate
PROCEDURE	adjuvant therapy
PROCEDURE	conventional surgery
PROCEDURE	neoadjuvant therapy

Timeline

• Start date: 2000-03-01
• Primary completion: 2006-12-01
• Completion: 2011-10-01
• First posted: 2003-01-27
• Last updated: 2015-06-08

Locations

4 sites across 1 country: United States