Status:
TERMINATED
Efficacy of Pegamotecan (PEG-Camptothecin) in Localized or Metastatic Cancer of the Stomach or Gastroesophageal Junction
Lead Sponsor:
Enzon Pharmaceuticals, Inc.
Conditions:
Cancer of Stomach
Gastroesophageal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 stomac...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00080002
Start Date
December 1 2003
Last Update
September 6 2012
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