Purpose

This randomized phase II trial studies how well fluorouracil, irinotecan hydrochloride, and oxaliplatin (combination chemotherapy) works and compares to gemcitabine hydrochloride and paclitaxel albumin-stabilized nanoparticle formulation before surgery in treating patients with pancreatic cancer that can be removed by surgery. Drugs used in chemotherapy, such as fluorouracil, irinotecan hydrochloride, oxaliplatin, gemcitabine hydrochloride, and paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether combination chemotherapy is more effective than gemcitabine hydrochloride and paclitaxel albumin-stabilized nanoparticle formulation before surgery in treating pancreatic cancer.

Category

IRB Number
20170708HU
NCT Number
NCT01436968
Open to Enrollment
Yes
Sponsor
Southwest Oncology Group -



Study Contact

Local Recruitment Point of Contact
Alexander Aguilera
alexander.aguilera@va.gov

Principal Investigator
Michael Liss

Regulatory Point of Contact
Alexander Aguilera
alexander.aguilera@va.gov

Regulatory Point of Contact
Kathleen Franklin
+1 (210) 617-5300
franklinkr@uthscsa.edu

Regulatory Point of Contact
Jennifer Whitehead
(210) 986-1295
jennifer.whitehead@va.gov

Regulatory Point of Contact
Lauri Kelly
lauri.kelly@va.gov

Regulatory Point of Contact
Michael Liss
michael.liss@va.gov



Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

    ude:

    • Localized prostate cancer meeting the NCCN criteria of Intermediate Risk or patients having only one NCCN high-risk feature

      • NCCN Intermediate Risk is defined as having at least one of the following: PSA 10-20 ng/ml, Gleason score =7, T2b-T2c
      • High Risk with a single high risk feature is defined as having only one of the following: PSA>20 ng/ml, Gleason score 8-10, or T3a
      • Excluded are those in the following risk groups: Low risk; High risk with more than 1 high risk factor; Locally advanced/very high risk=T3b-T4; Metastatic: N1 or M1
    • Planning to undergo standard prostate-only external beam radiation therapy
    • ECOG Performance Status 0-2
    <

Exclusion Criteria

    ude:

    • Liver disease, including known cirrhosis or active hepatitis
    • Patients on systemic corticosteroids (>10mg prednisone per day) or other immunosuppressive drugs
    • Known HIV+ patients
    • Regional lymph node involvement or distant metastases
    • Patients planning to receive whole pelvic irradiation
    • Prior treatment for prostate cancer, except TURP or ADT. For ADT, it may only be given for a maximum of 6 months
    • Patients who had or plan to have orchiectomy as the form of hormonal ablation
    • Known sensitivity or allergic reactions to acyclovir or valacyclovir

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Condition
  • Prostate Cancer

    • Arm Groups

    ArmDescriptionIntervention
    Experimental

    ProstAtak®

    		Aglatimagene besadenovec (CAN-2409) + valacyclovir + radiation therapy +/- ADT
  • Biological: Aglatimagene besadenovec + valacyclovir

    Patients will receive three courses of ProstAtak® each consisting of aglatimagene besadenovec injection + oral valacyclovir. AdV-tk injection will be delivered to the prostate via trans-rectal ultrasound guided injection as follows: The first injection will be given at least 15 days and not more than 8 weeks before starting radiation. The second injection will be 0-3 days before initiation of radiation therapy. The third injection will be 15-22 days after the 2nd injection. The prodrug, valacyclovir, will be administered at a fixed dose for 14 days after each AdV-tk injection. Standard external beam radiation therapy will be delivered to the prostate. Short-term androgen deprivation therapy (maximum of 6 months) is optional but must be decided before enrollment to allow for stratification.

    Other names:

    • AdV-tk
    • CAN-2409

    • Placebo Comparator

    Control

    		Placebo + valacyclovir + radiation therapy +/- ADT
  • Biological: Placebo + valacyclovir

    Patients will receive three courses each consisting of placebo injection + oral valacyclovir. Placebo injection will be delivered to the prostate via trans-rectal ultrasound guided injection as follows: The first injection will be given at least 15 days and not more than 8 weeks before starting radiation. The second injection will be 0-3 days before initiation of radiation therapy. The third injection will be 15-22 days after the 2nd injection. The prodrug, valacyclovir, will be administered at a fixed dose for 14 days after each placebo injection. Standard external beam radiation therapy will be delivered to the prostate. Short-term androgen deprivation therapy (maximum of 6 months) is optional but must be decided before enrollment to allow for stratification.

    •