Phase II Trial of Neoadjuvant Dose-Dense Doxorubicin, Ifosfamide, and Irinotecan (CPT-11) for Advanced Soft Tissue and Recurrent Bone Sarcomas
- To evaluate the effectiveness of neoadjuvant dose-dense chemotherapy comprising
doxorubicin hydrochloride, ifosfamide, and irinotecan hydrochloride in combination with
dexrazoxane hydrochloride followed by surgery and radiotherapy in patients with
advanced soft tissue sarcoma or recurrent bone sarcoma.
- To evaluate the toxicities of this regimen in these patients.
- To compare the duration of disease-free and overall survival of patients with advanced
soft tissue sarcoma who receive this therapy on a neoadjuvant basis with historical
- To evaluate laboratory correlates of chemotherapy resistance for the cytotoxic agents
used in this study.
OUTLINE: Patients are stratified by type of sarcoma (soft tissue vs bone), prior treatment
(untreated vs treated), and presence of metastases (yes vs no).
- Courses 1 and 2: Patients receive doxorubicin hydrochloride and dexrazoxane
hydrochloride IV continuously over 96 hours. Treatment repeats every 3 weeks for 2
- Courses 3 and 4: Patients receive ifosfamide IV over 2 hours twice a day (every 12
hours) on days 1-3. Treatment repeats every 3 weeks for 2 courses.
- Courses 5 and 6: Patients receive irinotecan hydrochloride IV over 1 hour once a day on
days 1-5 and 8-12. Treatment repeats every 3 weeks for 2 courses.
Patients also receive filgrastim (G-CSF) subcutaneously once a day beginning 3 days after
completion of chemotherapy and continuing until blood counts recover.
Patients then undergo standard surgery and radiotherapy.
Patients undergo blood sample collection periodically for correlative studies. Samples are
analyzed for MDR (multidrug resistance gene) protein expression via immunoperoxidase
After completion of study treatment, patients are followed every 3 months for 2 years, every
6 months for 2 years, and then once a year thereafter.
Primary Purpose: Treatment
Warren A. Chow, MD
Beckman Research Institute
United States: Federal Government