Status:
COMPLETED
A Study of REOLYSIN® in Combination With Gemcitabine in Patients With Advanced Pancreatic Adenocarcinoma
Lead Sponsor:
Oncolytics Biotech
Collaborating Sponsors:
University of Texas
Conditions:
Metastatic Pancreatic Adenocarcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this Phase 2 study is to investigate whether intravenous administration of REOLYSIN therapeutic reovirus in combination with gemcitabine is effective and safe in the treatment of patien...
Detailed Description
Pancreatic cancer remains one of the most lethal cancers, ranking as the fourth leading cause of cancer death for both men and women. The American Cancer Society estimates that 37,170 men and women (1...
Eligibility Criteria
Inclusion
- have advanced or metastatic pancreatic adenocarcinoma who have not previously received any chemotherapy or biotherapy. Patients who have received radiotherapy with or without radiotherapy enhancers (such as low dose 5-FU) will be eligible.
- have evidence of measurable disease. However, lesions in a previous radiation field are considered non-evaluable for response. Therefore, patients must have a measurable lesion that is not in a previously irradiated field to be eligible.
- have NO continuing acute toxic effects (except alopecia) of any prior radiotherapy or surgical procedures, i.e., all such effects must have resolved to Common Terminology Criteria for Adverse Events (CTCAE, Version 3.0) Grade ≤1. Surgery (except biopsies) must have occurred at least 28 days prior to study enrolment.
- have received NO radiotherapy within 28 days prior to receiving study drug.
- have an ECOG Performance Score ≤ 2.
- have a life expectancy of at least 3 months.
- absolute neutrophil count (ANC) ≥ 1.5 x 10\^9 \[SI units 10\^9/L\]; Platelets ≥ 100 x10\^9 \[SI units 10\^9/L\] (without platelet transfusion); Serum creatinine ≤ 1.5 x ULN; Bilirubin ≤ 1.5 x ULN; AST/ALT ≤ 2.5 x ULN (≤ 5 x ULN if patients have liver metastasis).
- negative pregnancy test for females of childbearing potential.
Exclusion
- no concurrent therapy with any other investigational anticancer agent while on study.
- have a history of or current evidence of brain metastasis(es).
- be on immunosuppressive therapy; have known HIV infection or active hepatitis B or C.
- be a pregnant or breast-feeding woman.
- have clinically significant cardiac disease.
- have dementia or altered mental status that would prohibit informed consent.
- have any other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the Principal Investigator, would make the patient inappropriate for this study.
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00998322
Start Date
October 1 2009
End Date
February 1 2015
Last Update
April 10 2015
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Montefiore Medical Center
New York, New York, United States, 10467
2
Cancer Therapy & Research Center at UTHSCSA
San Antonio, Texas, United States, 78229