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

Enzon Pharmaceuticals

Status and phase

Terminated

Phase 2

Conditions

Gastroesophageal Cancer

Cancer of Stomach

Treatments

Drug: Pegamotecan

Study type

Interventional

Funder types

Industry

Identifiers

NCT00080002

CAM-9011

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.