NCT00998322

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2009

Longer than P75 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

October 15, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 20, 2009

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

April 10, 2015

Status Verified

April 1, 2015

Enrollment Period

4.2 years

First QC Date

October 15, 2009

Last Update Submit

April 8, 2015

Conditions

Metastatic Pancreatic Adenocarcinoma

Keywords

metastaticpancreaticadenocarcinomaREOLYSINchemotherapygemcitabine

Outcome Measures

Primary Outcomes (1)

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

    4 weeks

Secondary Outcomes (2)

  • 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.

    Within 30 days of last dose of REOLYSIN

  • Determine the progression-free survival of this combination in patients with advanced or metastatic pancreatic adenocarcinoma.

    9-12 months

Interventions

REOLYSINBIOLOGICAL

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

GemcitabineDRUG

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

Also known as: Gemzar

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Montefiore Medical Center

New York, New York, 10467, United States

Location

Cancer Therapy & Research Center at UTHSCSA

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Neoplasm MetastasisAdenocarcinoma

Interventions

reolysinGemcitabine

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and SymptomsCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 15, 2009

First Posted

October 20, 2009

Study Start

October 1, 2009

Primary Completion

December 1, 2013

Study Completion

February 1, 2015

Last Updated

April 10, 2015

Record last verified: 2015-04

Locations

US(2)