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

September 5, 2012 updated by: Enzon Pharmaceuticals, Inc.
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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Enzon Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2003

Study Registration Dates

First Submitted

March 18, 2004

First Submitted That Met QC Criteria

March 19, 2004

First Posted (Estimate)

March 22, 2004

Study Record Updates

Last Update Posted (Estimate)

September 6, 2012

Last Update Submitted That Met QC Criteria

September 5, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAM-9009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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