Neoadjuvant and Adjuvant Pamidronate With Induction and Maintenance Chemotherapy in Treating Patients With Osteosarcoma - Article Cancer Chemotherapy
Clinical Trial: Neoadjuvant and Adjuvant Pamidronate With Induction and Maintenance Chemotherapy in Treating Patients With Osteosarcoma
This study is currently recruiting patients.
RATIONALE: Drugs used in chemotherapy, such as cisplatin, doxorubicin, and methotrexate, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining pamidronate with chemotherapy may prevent bone metastases and reduce the chance of bone replacement problems by strengthening bones in patients who are undergoing surgery for osteosarcoma.
PURPOSE: Phase II trial to study the effectiveness of combining neoadjuvant and adjuvant pamidronate with induction and maintenance chemotherapy in treating patients who have newly diagnosed osteosarcoma.
|Condition||Treatment or Intervention||Phase|
|localized osteosarcoma |
| Drug: cisplatin |
Procedure: adjuvant therapy
Procedure: bone metastases prevention
Procedure: conventional surgery
Procedure: high-dose chemotherapy
Procedure: hypercalcemia therapy
Procedure: neoadjuvant therapy
Procedure: supportive care/therapy
|Phase II |
MedlinePlus related topics: Bone Cancer
Study Type: Interventional
Study Design: Treatment
- Determine the safety and feasibility of pamidronate with standard induction and maintenance chemotherapy in patients with newly diagnosed high-grade osteosarcoma.
- Determine the frequency of favorable tumor necrosis produced in patients treated with this regimen.
- Determine the event-free survival of patients without metastatic disease at presentation treated with this regimen.
- Determine the prosthesis failure-free survival of patients treated with this regimen and who ultimately undergo limb preservation surgery with insertion of an endoprosthesis.
OUTLINE: Patients are stratified according to extent of disease (localized vs metastatic).
- Induction therapy: Patients receive standard chemotherapy comprising cisplatin IV over 4 hours and doxorubicin IV over 15-30 minutes on weeks 0 and 5 and high-dose methotrexate IV over 4 hours on weeks 3, 4, 8, and 9. Patients also receive pamidronate IV over 2-4 hours beginning approximately 3 days after initiation of chemotherapy on week 0 and repeating once every 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
- Surgery*: Patients undergo surgical resection of primary tumor on week 10 and then proceed to maintenance therapy. Patients with metastatic disease undergo further surgery of metastatic sites after recovery from definitive resection of the primary tumor before proceeding to maintenance therapy. NOTE: *Patients who have undergone definitive surgical resection before study entry may proceed to maintenance therapy or, if appropriate, surgical resection of metastatic disease
- Maintenance therapy: Patients receive standard chemotherapy comprising cisplatin IV over 4 hours on weeks 0 and 5; doxorubicin IV over 15-30 minutes on weeks 0, 5, 10, and 15; and high-dose methotrexate IV over 4 hours on weeks 3, 4, 8, 9, 13, 14, 18, and 19. Patients also receive pamidronate as in induction therapy for up to 1 year. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed monthly for 1 year.
Genders Eligible for Study: Both
- Histologically confirmed high-grade osteosarcoma
- Newly diagnosed
- Previously untreated
- Prior definitive surgical resection of primary tumor allowed
- No history of Paget's disease
PATIENT CHARACTERISTICS: Age
- Any age
- ECOG 0-2
- Not specified
- Platelet count at least 100,000/mm^3
- Absolute neutrophil at least 1,000/mm^3
- AST no greater than 3 times upper limit of normal (ULN)
- Bilirubin no greater than 1.5 times ULN
- Creatinine no greater than 1.5 times ULN
- Shortening fraction at least 28% by echocardiogram OR
- Ejection fraction at least 50% by radionuclide angiogram
- No history of pericarditis or myocarditis
- No history of symptomatic arrhythmia
- No history of symptomatic cardiac conduction abnormalities
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No history of other cancer
PRIOR CONCURRENT THERAPY: Biologic therapy
- Not specified
- No prior chemotherapy
- Not specified
- No prior radiotherapy
- See Disease Characteristics
- No prior treatment for cancer
- No concurrent enrollment on another therapeutic study
Location and Contact Information
Memorial Sloan-Kettering Cancer Center, New York, New York, 10021, United States; Recruiting
Paul A. Meyers, MD, Principal Investigator, Memorial Sloan-Kettering Cancer Center
Record last reviewed: October 2003
Last Updated: December 6, 2004
Record first received: November 4, 2003
ClinicalTrials.gov Identifier: NCT00072306
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Cache Date: April 9, 2005