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
Data Collection
Digestive System Diseases+8
+ Digestive System Neoplasms
+ Gastrointestinal Diseases
Treatment Study
Summary
Study start date: December 1, 2003
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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.