A Study of REOLYSIN® in Combination With Gemcitabine in Patients With Advanced Pancreatic Adenocarcinoma - Full Text View

Sponsor:	Oncolytics Biotech
Collaborator:	University of Texas
Information provided by (Responsible Party):	Oncolytics Biotech
ClinicalTrials.gov Identifier:	NCT00998322

Purpose

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	Intervention	Phase
Metastatic Pancreatic Adenocarcinoma	Biological: REOLYSIN Drug: Gemcitabine	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase 2 Study of REOLYSIN in Combination With Gemcitabine for Patients With Advanced Pancreatic Adenocarcinoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Gemcitabine Gemcitabine hydrochloride

U.S. FDA Resources

Further study details as provided by Oncolytics Biotech:

Primary Outcome Measures:

Determine the clinical benefit rate (Complete Response (CR) + Partial Response (PR) + Stable Disease (SD))in the study population [ Time Frame: 6-9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]
Determine the progression-free survival of this combination in patients with advanced or metastatic pancreatic adenocarcinoma. [ Time Frame: 9-12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	33
Study Start Date:	October 2009
Estimated Study Completion Date:	January 2012
Estimated Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Intervention Details:

1E10 TCID50, 1-hour intravenous infusion on Days 1 and 2 and then Days 8 and 9 of a 21-day cycle.

800 mg/m2 30-min infusion on Days 1 and 8 of a 21-day cycle.

Other Name: Gemzar

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00998322

Locations

United States, New York
Montefiore Medical Center	Recruiting
New York, New York, United States, 10467
Contact: Yoko Eng 718-920-2090 yeng@montefiore.org
Principal Investigator: Santiago Aparo, MD
United States, Texas
Cancer Therapy & Research Center at UTHSCSA	Recruiting
San Antonio, Texas, United States, 78229
Contact: Devalingam Mahalingam, MD, PhD 210-413-1723 Mahalingam@uthscsa.edu
Principal Investigator: Devalingam Mahalingam, MD, PhD
Veterans Affairs at UTHSCSA	Recruiting
San Antonio, Texas, United States, 78229
Contact: Epp Goodwin 210-450-5798 goodwine@uthscsa.edu
Principal Investigator: Anand Karnad, MD

Sponsors and Collaborators

Oncolytics Biotech

University of Texas

Investigators

Principal Investigator:

Monica Mita, MD

Cancer Therapy & Research Center at UTHSCSA

More Information

No publications provided

Responsible Party:	Oncolytics Biotech
ClinicalTrials.gov Identifier:	NCT00998322 History of Changes
Other Study ID Numbers:	REO 017
Study First Received:	October 15, 2009
Last Updated:	October 6, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Oncolytics Biotech:

metastatic
pancreatic
adenocarcinoma

REOLYSIN
chemotherapy
gemcitabine

Additional relevant MeSH terms:

Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on February 09, 2012