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
- Pathologically confirmed diagnosis of adenocarcinoma of the stomach or
- 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
- Adequate renal function, as determined by serum creatinine and serum albumin
- 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
- Capable of understanding the protocol requirements and risks and providing written
- 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
- Prior treatment with a camptothecin analog.