Efficacy and Safety Evaluation of Pegamotecan (PEG-camptothecin) in Advanced or Metastatic Soft Tissue Sarcoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00079950
Recruitment Status : Suspended
First Posted : March 22, 2004
Last Update Posted : September 6, 2012
Information provided by:
Enzon Pharmaceuticals, Inc.

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.

Condition or disease Intervention/treatment Phase
Sarcoma, Soft Tissue Drug: Pegamotecan Phase 2

Study Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : August 2003

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 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 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00079950

United States, California
Century City Hospital
Los Angeles, California, United States, 90067
United States, Pennsylvania
Pennsylvania Oncology Hematology Association
Philadelphia, Pennsylvania, United States, 19106
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15232
United States, Texas
Institute for Drug Development Cancer Therapy and Research Center
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Enzon Pharmaceuticals, Inc.

Responsible Party: Senior Director, Regulatory Affairs, Enzon Pharmaceuticals Identifier: NCT00079950     History of Changes
Other Study ID Numbers: CAM-9009
First Posted: March 22, 2004    Key Record Dates
Last Update Posted: September 6, 2012
Last Verified: September 2012

Keywords provided by Enzon Pharmaceuticals, Inc.:

Additional relevant MeSH terms:
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type