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Osteosarcoma 1999-A Study Of Intensive Chemotherapy Utilizing Ifosfamide, Carboplatin, and Doxorubicin for Adjuvant Chemotherapy for Treatment of Osteosarcoma


Phase 2
N/A
25 Years
Not Enrolling
Both
Osteosarcoma

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Trial Information

Osteosarcoma 1999-A Study Of Intensive Chemotherapy Utilizing Ifosfamide, Carboplatin, and Doxorubicin for Adjuvant Chemotherapy for Treatment of Osteosarcoma


This study has multiple research objectives:

- To compare the response rate of pre-surgical chemotherapy comprised of ifosfamide,
doxorubicin, and carboplatin to that obtained with ifosfamide and carboplatin in the
St. Jude OS-91 trial for patients with non-metastatic resectable osteosarcoma

- To continue the evaluation of dynamic contrast-enhanced magnetic resonance imaging
(DEMRI) in predicting tumor response and accurately assessing the degree of response
(continued from OS-91).

- To determine the feasibility of delivering outpatient-based chemotherapy for
osteosarcoma using ifosfamide-doxorubicin-carboplatin.

- To determine whether resection of the primary site may be satisfactorily performed with
a 3 cm margin of normal bone (rather than 5 cm).

- To study biologic and biochemical characteristics of the tumor cells that may be of
prognostic significance

- To study the patients' and parents' perspectives of the patients' quality of life
during and after treatment.

Description of Treatment Plan:

This study employs the following treatment strategy: neoadjuvant chemotherapy followed by
definitive surgery for local control and adjuvant chemotherapy after tumor resection.

Pre-operative chemotherapy phase (weeks 0-12): Three courses of ifosfamide/carboplatin
given every 3 weeks followed by one 3-week course of doxorubicin.Disease evaluation is
performed after 3 courses and after 4 courses of chemotherapy.

Weeks 0, 3, and 6 - Ifosfamide-Carboplatin Ifosfamide: 2.65 gm/m2 IV daily over 15-30
minutes x 3 (Days 1, 2, 3) with MESNA. Carboplatin: dose based on GFR and targeted to an
AUC of 8 mg/mL/min, given IV over 1 hour (Day 1 only)

Week 9- Evaluation, followed by Doxorubicin Doxorubicin: 25 mg/m2 IV over 1 hour, daily x 3

Week 12 Evaluation followed by definitive Surgery Local control by amputation or
limb-salvage procedure

Post-operative chemotherapy (Weeks 14-35) Ifosfamide, carboplatin, and doxorubicin in
two-agent pairs for approximately 35 weeks.

Week 14 - Ifosfamide-Doxorubicin Ifosfamide: 2.65 gm/m2 IV daily over 15-30 minutes x 3
(Days 1, 2, 3) with MESNA, Doxorubicin: 25 mg/m2 IV over 1 hour, daily x 2 (Days 1 and 2)

Week 17 - Ifosfamide-Carboplatin Ifosfamide: 2.65 gm/m2 IV daily over 15-30 minutes x 3
(Days 1, 2, 3) with MESNA, Carboplatin: targeted to an AUC of 8 mg/mL/min given IV over 1
hour (Day 1 only)

Week 20 - Carboplatin-Doxorubicin Carboplatin: targeted to an AUC of 8 mg/mL/min given IV
over 1 hour (Day 1 only), Doxorubicin: 25 mg/m2 IV over 1 hour, daily x 2 (Days 1 and 2)

Week 23 - Evaluation, followed by Ifosfamide:

Doxorubicin. Ifosfamide: 2.65 gm/m2 IV daily over 15-30 minutes x 3 (Days 1, 2, 3) with
MESNA, Doxorubicin: 25 mg/m2 IV over 1 hour, daily x 2 (Days 1 and 2)

Week 26 - Ifosfamide-Carboplatin Ifosfamide: 2.65 gm/m2 IV daily over 15-30 minutes x 3
(Days 1, 2, 3) with MESNA, Carboplatin: targeted to an AUC of 8 mg/mL/min given IV over 1
hour (Day 1 only)

Week 29 - Carboplatin-Doxorubicin Carboplatin: targeted to an AUC of 8 mg/mL/min given IV
over 1 hour (Day 1 only), Doxorubicin: 25 mg/m2 IV over 1 hour, daily x 2 (Days 1 and 2)

Week 32 - Evaluation, followed by Ifosfamide-Doxorubicin. Ifosfamide: 2.65 gm/m2 IV daily
over 15-30 minutes x 3 (Days 1, 2, 3) with MESNA, Doxorubicin: 25 mg/m2 IV over 1 hour,
daily x 2 (Days 1 and 2)

Week 35 - Carboplatin-Doxorubicin Carboplatin: targeted to an AUC of 8 mg/mL/min given IV
over 1 hour (Day 1 only), Doxorubicin: 25 mg/m2 IV over 1 hour, daily x 2 (Days 1 and 2)


Inclusion Criteria:



- All subjects with histologically proven high-grade osteosarcoma,chondrosarcoma, MFH,
fibrosarcoma or chondrosarcoma of bone, whose tumors are potentially resectable
(either by limb sparing, en bloc resection, or amputation) and have no evidence of
metastasis.

- Adequate liver, renal and cardiac function.

- Age: Younger than 25 years old

Exclusion Criteria:

- Prior chemotherapy

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Histologic response rate

Outcome Time Frame:

After all patients have undergone definitive surgery and become evaluable for histologic response evaluation.

Principal Investigator

Fariba Navid, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

St. Jude Children's Research Hospital

Authority:

United States: Institutional Review Board

Study ID:

OS99

NCT ID:

NCT00145639

Start Date:

May 1999

Completion Date:

May 2006

Related Keywords:

  • Osteosarcoma
  • Osteosarcoma
  • Treatment, Carboplatin
  • Osteosarcoma

Name

Location

Washington University Medical CenterSaint Louis, Missouri  63105
Arkansas Children's HospitalLittle Rock, Arkansas  72202-3591
St.Jude Children's Research HospitalMemphis, Tennessee  38105