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Phase II Trial of Neoadjuvant Dose-Dense Doxorubicin, Ifosfamide, and Irinotecan (CPT-11) for Advanced Soft Tissue and Recurrent Bone Sarcomas

Phase 2
18 Years
65 Years
Not Enrolling

Thank you

Trial Information

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.

Inclusion Criteria


- Diagnosis of 1 of the following:

- Primary soft tissue sarcoma at high-risk* for recurrence, meeting any of the
following criteria:

- Previously untreated locally advanced, nonmetastatic disease

- Advanced (metastatic) disease not amenable to standard or higher priority
investigational neoadjuvant therapies

- Recurrent bone sarcoma (e.g., osteogenic sarcoma, Ewing sarcoma, or peripheral
neuroectodermal tumor)

- Must have advanced locally recurrent or metastatic disease NOTE: *High-risk
is defined as high-grade, deep to fascia, and > 5 cm in greatest dimension

- Measurable or nonmeasurable disease is not required

- Pre-chemotherapy consultation with surgery and radiation oncology is required for
formulation of loco-regional therapy

- No gastrointestinal stromal cell sarcoma

- No alveolar soft part sarcoma

- No symptomatic brain metastases

- No requirement for anticonvulsant or corticosteroid therapy


- Karnofsky performance status 70-100%

- Life expectancy ≥ 2 months

- Absolute neutrophil count ≥ 2,000/mm^3

- Platelet count > 120,000/mm^3

- Creatinine clearance > 50 mL/min

- Serum bilirubin ≤ 1.5 mg/dL

- SGOT or SGPT ≤ 2.5 times upper limit of normal

- Serum albumin ≥ 2.5 mg/dL

- LVEF ≥ 50% by MUGA scan

- Not pregnant or nursing

- Fertile patients must use effective contraception

- No concurrent nonmalignant illness (e.g., cardiovascular, pulmonary, or CNS disease)
that is poorly controlled with currently available treatment or is of such severity
that the investigators deem it unwise for the patient to enter the study


- See Disease Characteristics

- No prior chemotherapy for recurrent (local or metastatic) soft tissue sarcoma

- Prior chemotherapy for recurrent bone sarcoma allowed provided the total dose of
doxorubicin hydrochloride is ≤ 300 mg/m^2

- No prior radiotherapy to > 25% of bone marrow

- At least 3 weeks since prior radiotherapy or chemotherapy

Type of Study:


Study Design:

Primary Purpose: Treatment

Outcome Measure:

Response rate

Safety Issue:


Principal Investigator

Warren A. Chow, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Beckman Research Institute


United States: Federal Government

Study ID:




Start Date:

August 2001

Completion Date:

Related Keywords:

  • Sarcoma
  • recurrent adult soft tissue sarcoma
  • stage III adult soft tissue sarcoma
  • stage IV adult soft tissue sarcoma
  • metastatic osteosarcoma
  • recurrent osteosarcoma
  • metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor
  • recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor
  • Ewing sarcoma of bone
  • Osteosarcoma
  • Neuroectodermal Tumors, Primitive, Peripheral
  • Sarcoma