Clincosm LogoSign in Get a demo

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

Sponsor
Enzon Pharmaceuticals, Inc. (Industry)
Overall Status
Suspended
CT.gov ID
NCT00079950
Collaborator
(none)
4
Locations

Study Details

Study Description

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
Phase 2

Study Design

Study Type:
Interventional
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Study Start Date :
Aug 1, 2003

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    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).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    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

    Sponsors and Collaborators

    • Enzon Pharmaceuticals, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00079950
    Other Study ID Numbers:
    • CAM-9009
    First Posted:
    Mar 22, 2004
    Last Update Posted:
    Sep 6, 2012
    Last Verified:
    Sep 1, 2012
    Keywords provided by , ,
    soft
    sarcoma
    metastatic
    Additional relevant MeSH terms:
    Sarcoma

    Study Results

    No Results Posted as of Sep 6, 2012