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

Sarcoma, Soft Tissue Clinical Trial

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT00079950
• Other study ID #: CAM-9009
• Status: Suspended
• Phase: Phase 2
• First received: March 18, 2004
• Last updated: September 5, 2012
• Start date: August 2003

Study information

• Verified date: September 2012
• Source: Enzon Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sarcoma
• Sarcoma, Soft Tissue

Intervention

Drug:
• Pegamotecan

Locations

Country	Name	City	State
United States	Century City Hospital	Los Angeles	California
United States	Pennsylvania Oncology Hematology Association	Philadelphia	Pennsylvania
United States	University of Pittsburgh Cancer Institute	Pittsburgh	Pennsylvania
United States	Institute for Drug Development Cancer Therapy and Research Center	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Enzon Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States,