Status:
COMPLETED
Clinical and Pharmacokinetic Trial of Intra-Abdominal Irinotecan
Lead Sponsor:
University of Southern California
Conditions:
Adenocarcinoma
Gastric Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is a research study for patients that have an advanced cancer that is confined mostly to the abdominal cavity and have failed treatment with conventional therapy, or for which no standard treatme...
Eligibility Criteria
Inclusion
- Histologically confirmed recurrent, metastatic, or residual cancer with disease confined mostly to the peritoneal cavity. Patients with asymptomatic extra-peritoneal disease are eligible.
- Measurable or evaluable disease. Patients with malignant ascites or carcinomatosis only (documented by cytology or during surgery) are eligible. Patients with ovarian cancer and disease manifested only by an elevated CA-125 are also eligible.
- Adequate hepatic, renal, and bone marrow functions: bilirubin less than or equal to 2.0 mg/dl; creatinine less than or equal to 2.0 mg/dl, alkaline phosphatase less than or equal to 3 x upper limit of normal (uln), AST or ALT less than or equal to 3 x uln; AGC greater than or equal to 1500, platelets greater than or equal to 100,000.
- SWOG performance status 0-2
- Fully recovered from acute toxicities from prior surgery, chemotherapy, or radiation therapy.
- Patients must use an approved method of birth control.
Exclusion
- Medical, social, or psychological factors which could prevent patient from receiving treatment.
- Prior therapy with intra-peritoneal irinotecan
- Significant intra-peritoneal adhesions detected clinically or by prior surgical exploration
Key Trial Info
Start Date :
September 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00183859
Start Date
September 1 1999
End Date
April 1 2009
Last Update
May 22 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
U.S.C. / Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033