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

This study has been terminated.

Sponsored by: Enzon Pharmaceuticals, Inc.
Information provided by: Enzon Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00080002
  Purpose

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.


Condition Intervention Phase
Cancer of Stomach
Gastroesophageal Cancer
Drug: Pegamotecan
Phase II

MedlinePlus related topics:   Cancer    Stomach Cancer   

Drug Information available for:   Camptothecin    Pegamotecan   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:   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

Further study details as provided by Enzon Pharmaceuticals, Inc.:

Study Start Date:   December 2003

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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.
  Contacts and Locations

No Contacts or Locations Provided
  More Information


Study ID Numbers:   CAM-9011
First Received:   March 19, 2004
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00080002
Health Authority:   United States: Food and Drug Administration

Keywords provided by Enzon Pharmaceuticals, Inc.:
cancer  
gastric  
gastroesophageal junction  
neoplasms
gastric cancer
gastric neoplasms

Study placed in the following topic categories:
Stomach Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Stomach Neoplasms
Neoplasm Metastasis
Gastrointestinal Neoplasms
Stomach cancer
Camptothecin

Additional relevant MeSH terms:
Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2008




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