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A Phase 2 Study of REOLYSIN in Combination With Gemcitabine for Patients With Advanced Pancreatic Adenocarcinoma

Phase 2
18 Years
Open (Enrolling)
Metastatic Pancreatic Adenocarcinoma

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Trial Information

A Phase 2 Study of REOLYSIN in Combination With Gemcitabine for Patients With Advanced Pancreatic Adenocarcinoma

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.

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

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine the clinical benefit rate (Complete Response (CR) + Partial Response (PR) + Stable Disease (SD))in the study population

Outcome Time Frame:

4 weeks

Safety Issue:



United States: Food and Drug Administration

Study ID:

REO 017



Start Date:

October 2009

Completion Date:

October 2013

Related Keywords:

  • Metastatic Pancreatic Adenocarcinoma
  • metastatic
  • pancreatic
  • adenocarcinoma
  • chemotherapy
  • gemcitabine
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous



Montefiore Medical Center Bronx, New York  10467-2490
Cancer Therapy & Research Center at UTHSCSA San Antonio, Texas  78229