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

Gastroesophageal Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00080002
• Other study ID #: CAM-9011
• Status: Terminated
• Phase: Phase 2
• First received: March 19, 2004
• Last updated: September 5, 2012
• Start date: December 2003

Study information

• Verified date: March 2005
• 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 pathologically-diagnosed locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction who have relapsed or progressed following one prior chemotherapy treatment regimen.

Recruitment information / eligibility

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

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Cancer of Stomach
• Gastroesophageal Cancer
• Neoplasm Metastasis
• Stomach Neoplasms

Intervention

Drug:
• Pegamotecan

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Enzon Pharmaceuticals, Inc.