Efficacy and Safety Evaluation of Pegamotecan (PEG-camptothecin) in Advanced or Metastatic Soft Tissue Sarcoma
1 other identifier
interventional
N/A
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
4 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2003
CompletedFirst Submitted
Initial submission to the registry
March 18, 2004
CompletedFirst Posted
Study publicly available on registry
March 22, 2004
CompletedSeptember 6, 2012
September 1, 2012
March 18, 2004
September 5, 2012
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Century City Hospital
Los Angeles, California, 90067, United States
Pennsylvania Oncology Hematology Association
Philadelphia, Pennsylvania, 19106, United States
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15232, United States
Institute for Drug Development Cancer Therapy and Research Center
San Antonio, Texas, 78229, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 18, 2004
First Posted
March 22, 2004
Study Start
August 1, 2003
Last Updated
September 6, 2012
Record last verified: 2012-09