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A Study of REOLYSIN® in Combination With Gemcitabine in Patients With Advanced Pancreatic Adenocarcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00998322
Recruitment Status : Completed
First Posted : October 20, 2009
Last Update Posted : April 10, 2015
University of Texas
Information provided by (Responsible Party):
Oncolytics Biotech

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 patients with advanced pancreatic cancer.

Condition or disease Intervention/treatment Phase
Metastatic Pancreatic Adenocarcinoma Biological: REOLYSIN Drug: Gemcitabine Phase 2

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 (18,830 men and 18,340 women) will be diagnosed with pancreatic cancer and 33,370 men and women will die of pancreatic cancer in 2008.

Activating KRAS mutations are the most frequent genetic abnormalities in pancreatic cancer (occurring in 75% to 95% of patients).

REOLYSIN has been demonstrated to kill a wide variety of cells with mutations along the RAS pathway, including pancreatic cancer cells.

The Phase 2 study is designed to characterize the efficacy and safety of REOLYSIN given intravenously in combination with gemcitabine every 3 weeks in patients with advanced pancreatic cancer.

Response is a primary endpoint of this trial. Tumors will be evaluated by CT scan within 14 days of starting treatment, then at 6 weeks, and then every 6 weeks thereafter.

The safety of the gemcitabine and REOLYSIN combination will be assessed by the evaluation of the type, frequency and severity of adverse events, changes in clinical laboratory tests, immunogenicity and physical examination.

Patients may continue to receive therapy under this protocol, provided he/she has not experienced either progressive disease or unacceptable drug-related toxicity that does not respond to either supportive care or dose reduction.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of REOLYSIN in Combination With Gemcitabine for Patients With Advanced Pancreatic Adenocarcinoma
Study Start Date : October 2009
Actual Primary Completion Date : December 2013
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

Intervention Details:
  • Biological: REOLYSIN
    1E10 TCID50, 1-hour intravenous infusion on Days 1 and 2 and then Days 8 and 9 of a 21-day cycle.
  • Drug: Gemcitabine
    800 mg/m2 30-min infusion on Days 1 and 8 of a 21-day cycle.
    Other Name: Gemzar

Primary Outcome Measures :
  1. Determine the clinical benefit rate (Complete Response (CR) + Partial Response (PR) + Stable Disease (SD))in the study population [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Evaluate the safety and tolerability of the treatment regimen in the study population as measured by adverse events associated with the study treatment, and defined by established criteria. [ Time Frame: Within 30 days of last dose of REOLYSIN ]
  2. Determine the progression-free survival of this combination in patients with advanced or metastatic pancreatic adenocarcinoma. [ Time Frame: 9-12 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00998322

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United States, New York
Montefiore Medical Center
New York, New York, United States, 10467
United States, Texas
Cancer Therapy & Research Center at UTHSCSA
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Oncolytics Biotech
University of Texas
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Responsible Party: Oncolytics Biotech Identifier: NCT00998322    
Other Study ID Numbers: REO 017
First Posted: October 20, 2009    Key Record Dates
Last Update Posted: April 10, 2015
Last Verified: April 2015
Keywords provided by Oncolytics Biotech:
Additional relevant MeSH terms:
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Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs