Status:
SUSPENDED
Efficacy and Safety Evaluation of Pegamotecan (PEG-camptothecin) in Advanced or Metastatic Soft Tissue Sarcoma
Lead Sponsor:
Enzon Pharmaceuticals, Inc.
Conditions:
Sarcoma, Soft Tissue
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of Pegamotecan (Peg-Camptothecin) in patients with Advanced or Metastatic Soft Tissue sarcoma.
Eligibility Criteria
Inclusion
- 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 count.
- 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
- 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).
Key Trial Info
Start Date :
August 1 2003
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00079950
Start Date
August 1 2003
Last Update
September 6 2012
Active Locations (4)
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1
Century City Hospital
Los Angeles, California, United States, 90067
2
Pennsylvania Oncology Hematology Association
Philadelphia, Pennsylvania, United States, 19106
3
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15232
4
Institute for Drug Development Cancer Therapy and Research Center
San Antonio, Texas, United States, 78229