Protocol Summary

Protocol No.: OCR15253

Sponsor Protocol No.: IIT-USA-0115; UF-STO-PANC-003

Study Title
A Phase II Trial of TAS-102 (Lonsurf) in Patients With Metastatic or Locally Advanced Unresectable Pancreatic Adenocarcinoma After Progression Through First Line Chemotherapy

Principal Investigator(s)
Duff, Jennifer

Objective
This is an open-label, non-randomized, sequentially enrolling single arm phase II trial to evaluate the activity of TAS-102 in previously treated metastatic and locally advanced unresectable pancreatic cancer after progression through or intolerance to first line chemotherapy. Trial therapy will consist of TAS-102 (Lonsurf®) 35 mg/m2 to be given orally twice daily on days 1-5 and 8-12 with cycles repeating every 28 days. The primary endpoint is to determine the progression free survival (PFS) in subjects with unresectable pancreatic adenocarcinoma.

Phase: Phase II

Age Group: Adult

Scope: Local

Treatment
TAS-102
TAS-102 (35 mg/m2/dose) orally 2 times daily beginning the morning of Day 1 of each cycle and ending the evening of Day 5 of each cycle, as well as beginning the morning of Day 8 and ending the evening of Day 12 of each cycle. No TAS-102 will be given on Days 6-7 or Days 13-28 of each cycle.

Detailed Eligibility
INCLUSION CRITERIA:
1. Ages 18 to 90 years old
2. Histologic or cytologic confirmed adenocarcinoma of the pancreas.
3. Clinically metastatic or locally advanced unresectable disease as verified by radiographic imaging.
4. Documented progression or intolerance to first line chemotherapy.
5. TAS102 will be planned to start after disease progression on first-line chemotherapy, provided any prior chemotherapy-related toxicities have resolved to less than or equal to Grade 1 or baseline. Grade 2 or greater toxicities including alopecia, skin pigmentation,and platinum induced neurotoxicity/neuropathy are acceptable for starting on trial, as these toxicities do not preclude treatment with TAS102
6. ECOG Performance Status of 0-2
7. Capacity to understand and sign the informed consent document
8. Able to take medications orally
9. Life expectancy > 12 weeks as predicted by the treating oncologist's clinician judgement
10. Patients of childbearing potential must be using an effective means of contraception including but not limited to barrier methods, birth control, intrauterine devices.
11. Histologic diagnosis of pancreatic cancer that has been treated previously with one line of chemotherapy.
12. Previous surgery and/or radiotherapy could have been performed up to one month prior to study enrollment, but there must be evidence of disease progression radiographically or intolerance to first-line chemotherapy.
13. Patients on anticoagulation need to have no evidence of bleeding and be on a stable anticoagulation dose for at least 2 weeks prior to trial enrollment
14. Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for at least 6 months after the last dose of study drug to minimize the risk of pregnancy. Prior to study enrollment, women of childbearing potential must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy.
15. WOCBP include any woman who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or who is not post-menopausal. Post-menopause is defined as:
- Amenorrhea that has lasted for ≥ 12 consecutive months without another cause, or
- For women with irregular menstrual periods who are taking hormone replacement therapy (HRT), a documented serum follicle-stimulating hormone (FSH) level of greater than 35 mIU/mL.
- Males with female partners of child-bearing potential must agree to use physician-approved contraceptive methods (e.g., abstinence, condoms, vasectomy) throughout the study and should avoid conceiving children for 3 months following the last dose of study drug.
16. Subjects must have provided written informed consent and be willing to comply with all study-related procedures.
17. Baseline laboratory values (bone marrow, renal, hepatic) must include:
- Adequate bone marrow function:
- Absolute neutrophil count >1500/µL
- Platelet count >75,000/µL
- HGB equal to or greater than 7g/dL
- Renal function:
- Serum creatinine = - Hepatic function:
- Total bilirubin = - AST and ALT equal to or less than 3 times the upper limit of normal
- Serum calcium =

Applicable Disease Sites
Pancreatic Cancer

Participating Institutions
UF Gainesville : Allison Trainor

Contact
Allison Trainor
Phone: +1 352-265-0680 ext. 50703

Email: awickham@ufl.edu