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Phase 2
18 Years
Not Enrolling
Sarcoma, Soft Tissue

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Trial Information

Inclusion Criteria:

- Histologically or cytologically confirmed diagnosis of soft tissue sarcoma with
measurable disease.

- Target tumors outside prior radiation field(s).

- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.

- Adequate hematologic profile, as determined by hemoglobin, platelet, and neutrophil

- Adequate renal function

- Adequate liver function

- No history of hemorrhagic cystitis or evidence of microscopic hematuria

- Capable of understanding the protocol requirements and risks and providing written
informed consent.

- Either 0 or 1 prior chemotherapy regimens

Exclusion Criteria:

- Subject has a diagnosis of gastrointestinal stromal tumors.

- Concurrent serious medical illness unrelated to tumor within the past 6 months.

- Known chronic infectious disease, such as AIDS or hepatitis.

- Positive screening pregnancy test or is breast-feeding.

- A female or male subject of reproductive capacity unwilling to use methods
appropriate to prevent pregnancy during the course of this study.

- Receiving concurrent chemotherapy, radiotherapy, or surgery, or has received wide
field radiation within the previous 4 weeks.

- History of another active malignancy (except non-melanoma skin cancer and carcinoma
in situ of the cervix), unless in complete remission and off all therapy for that
disease for the last 2 years.

- Known or clinically suspected brain metastases.

- Received more than one prior treatment regimen (excluding adjuvant or neoadjuvant
therapy) for soft tissue sarcoma.

- Received any investigational drug within the last 30 days.

- Not fully recovered from any prior surgery (at least 4 weeks recovery period for
major surgery), and from any reversible side effects related to the administration of
cytotoxic chemotherapy or radiation therapy.

- Received a prior camptothecin analog (e.g., topotecan, irinotecan).

Type of Study:


Study Design:

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


United States: Food and Drug Administration

Study ID:




Start Date:

August 2003

Completion Date:

Related Keywords:

  • Sarcoma, Soft Tissue
  • soft
  • sarcoma
  • metastatic
  • Sarcoma



University of Pittsburgh Cancer Institute Pittsburgh, Pennsylvania  15213
Century City Hospital Los Angeles, California  90067
Institute for Drug Development Cancer Therapy and Research Center San Antonio, Texas  78229
Pennsylvania Oncology Hematology Association Philadelphia, Pennsylvania  19106