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


Phase 2
N/A
N/A
Not Enrolling
Both
Sarcoma

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Trial Information

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


OBJECTIVES:

- 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.

PROJECTED ACCRUAL: A total of 75 patients (50 with localized disease; 25 with metastatic
disease) will be accrued for this study within 3-4 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- 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

Performance status

- ECOG 0-2

Life expectancy

- Not specified

Hematopoietic

- Platelet count at least 100,000/mm^3

- Absolute neutrophil at least 1,000/mm^3

Hepatic

- AST no greater than 3 times upper limit of normal (ULN)

- Bilirubin no greater than 1.5 times ULN

Renal

- Creatinine no greater than 1.5 times ULN

Cardiovascular

- 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

Other

- 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

Chemotherapy

- No prior chemotherapy

Endocrine therapy

- Not specified

Radiotherapy

- No prior radiotherapy

Surgery

- See Disease Characteristics

Other

- No prior treatment for cancer

- No concurrent enrollment on another therapeutic study

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Event-free survival 3 years after completion of study treatment

Safety Issue:

No

Principal Investigator

Paul A. Meyers, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000339591

NCT ID:

NCT00072306

Start Date:

July 2003

Completion Date:

Related Keywords:

  • Sarcoma
  • localized osteosarcoma
  • metastatic osteosarcoma
  • Osteosarcoma
  • Sarcoma

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021