Efficacy of Pegamotecan (PEG-Camptothecin) in Localized or Metastatic Cancer of the Stomach or Gastroesophageal Junction

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

Effectiveness and Safety Study of Pegamotecan (PEG-Camptothecin) in Patients With Locally Advanced or Metastatic Cancer of the Stomach or Gastroesophageal Junction Who Have Relapsed or Progressed Following a Previous Chemotherapy Treatment

The purpose of this study is to evaluate the safety and efficacy of pegamotecan (PEG-camptothecin) in patients with pathologically-diagnosed locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction who have relapsed or progressed following one prior chemotherapy treatment regimen.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

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:

  • Pathologically confirmed diagnosis of adenocarcinoma of the stomach or gastroesophageal junction.
  • Disease measurable in at least one dimension.
  • Target tumors outside of prior radiation field(s).
  • An Eastern Cooperative Oncology Group (ECOG) performance scale score of 0 or 1
  • Adequate hematologic profile, as determined by hemoglobin, platelet, and neutrophil count.
  • Adequate renal function, as determined by serum creatinine and serum albumin measurements.
  • Adequate liver function, as determined by total bilirubin and transaminases levels. Transaminases may be <= 5.0x ULN if due to metastatic disease in the liver.
  • Fully recovered from prior surgery.
  • No history of hemorrhagic cystitis.
  • No microscopic hematuria (>10 RBC/hpf) unless documented to be due to an infection or non-bladder origin.
  • Capable of understanding the protocol requirements and risks and providing written informed consent.

Exclusion Criteria:

  • Concurrent serious medical illness unrelated to tumor within the past 6 months.
  • Known chronic infectious disease, such as AIDS or hepatitis (screening for hepatitis and HIV will not be performed).
  • Positive screening pregnancy test or is breast-feeding.
  • Female or male subject of reproductive capacity who is unwilling to use methods appropriate to prevent pregnancy during the course of this study.
  • Receiving concurrent chemotherapy, investigational agents, radiotherapy, surgery, or has received wide field radiation within the previous 4 weeks.
  • History of another malignancy (except basal and squamous cell carcinomas of the skin and carcinoma in situ of the cervix) within the last 5 years.
  • Known or clinically suspected brain metastases.
  • Received more than one prior regimen of chemotherapy for locally advanced or metastatic adenocarcinoma of the stomach or GE junction.
  • Received prior neoadjuvant and/or adjuvant cytotoxic chemotherapy
  • Received any investigational drug within the last 30 days.
  • Not fully recovered from any prior, and from any reversible side effects related to the administration of cytotoxic chemotherapy, investigational agents, or radiation therapy.
  • Prior treatment with a camptothecin analog.

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

December 1, 2003

Study Registration Dates

First Submitted

March 19, 2004

First Submitted That Met QC Criteria

March 22, 2004

First Posted (Estimate)

March 23, 2004

Study Record Updates

Last Update Posted (Estimate)

September 6, 2012

Last Update Submitted That Met QC Criteria

September 5, 2012

Last Verified

March 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAM-9011

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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