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A Phase I Dose-Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of Vitamin E δ-Tocotrienol Administered to Subjects With Resectable Pancreatic Exocrine Neoplasia


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Pancreatic Neoplasms

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Trial Information

A Phase I Dose-Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of Vitamin E δ-Tocotrienol Administered to Subjects With Resectable Pancreatic Exocrine Neoplasia


Delta-tocotrienol is a natural Vitamin E compound that has been consumed by humans as a
dietary supplement. The Food and Drug Administration (FDA) has not approved it for sale as
a drug. Vitamin E Delta-tocotrienol is being investigated for the prevention and treatment
of pancreatic tumors. The usefulness of the Vitamin E Delta-tocotrienol in treating human
tumors is unknown.

This study consists of the following: (1) a Pre-Treatment Period in which participants are
consented and qualified for the study; (2) a Study Treatment Period in which participant
will receive Vitamin E δ-Tocotrienol administered orally twice daily for 14 (±2) consecutive
days and once on the day of surgery, with associated pharmacokinetic and pharmacodynamic
sampling; (3) a Post Treatment Period in which laboratory and physical examinations are
performed. Adverse events will be recorded throughout the study.


Inclusion Criteria:



- The patient has a resectable tumor or cyst arising from the pancreatic exocrine gland
(pancreatic ductal adenocarcinoma, intraductal papillary mucinous neoplasm of the
pancreas, or mucinous cystic neoplasm of the pancreas) and is undergoing surgical
resection of the neoplasm.

- The patient is not a candidate for neoadjuvant chemoradiation therapy (i.e., patients
with borderline resectable pancreatic ductal adenocarcinoma who are known to benefit
from neoadjuvant treatment regimens).

- The patient has an Eastern Cooperative Oncology Group (ECOG) performance status of
≤2.

- The patient has adequate organ function as follows: Serum creatinine ≤1.5 mg/dL or
calculated creatinine clearance >60 mL/min; Bilirubin ≤ the institutional upper limit
of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)
≤2.5 times the upper limit of normal if no liver involvement or ≤5 times the upper
limit of normal with liver involvement; absolute neutrophil count (ANC) ≥ 1000mm³;
Platelet count ≥100,000/mm³.

- The patient has the capability of understanding the informed consent document and has
signed the informed consent document.

- Sexually active patients (male and female) must use medically acceptable methods of
contraception during the course of the study.

- Female patients of childbearing potential must have a negative pregnancy test at
screening.

- Able to understand and comply with the requirements of the protocol.

Exclusion Criteria:

- The patient is receiving concomitant radiotherapy, chemotherapy, other antineoplastic
therapy, or investigational therapy (other than the investigational therapy under
study).

- The patient has received radiation therapy, chemotherapy, other anti-neoplastic
therapy, or investigational therapy within 30 days prior to first dose of study drug.

- The patient has had prior major surgery within 30 days prior to first dose of study
drug.

- The patient has active infection or fever >38.5 C within 3 days prior to first dose
of study drug.

- The patient has uncontrolled intercurrent illness including, but not limited to,
ongoing or active infection, hypertension, symptomatic congestive heart failure,
unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social
situations that would limit compliance with study requirements.

- The patient is unable or unwilling to stop taking vitamins, herbal remedies, or
nonprescription medications.

- The patient is pregnant or breastfeeding.

- The patient is unable or unwilling to abide by the study protocol or cooperate fully
with the investigator or designee.

- The patient is a candidate for neo-adjuvant radiation therapy.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Maximum Tolerated Dose (MTD)

Outcome Description:

To determine the recommended Phase II dose of Vitamin E δ-Tocotrienol which will be defined as the biologic effective dose (BED) which induces significant apoptosis in the pancreatic neoplastic cells of resected tumor specimens following oral administration of Vitamin E δ-Tocotrienol twice daily for 14 (± 2)days prior to surgery, and one dose the day of surgery.

Outcome Time Frame:

12 weeks per participant

Safety Issue:

No

Principal Investigator

Gregory Springett, M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute

Authority:

United States: Food and Drug Administration

Study ID:

MCC-15630

NCT ID:

NCT00985777

Start Date:

September 2009

Completion Date:

December 2013

Related Keywords:

  • Pancreatic Neoplasms
  • pancreas
  • resectable
  • pancreatic tumor
  • pancreatic ductal adenocarcinoma
  • intraductal papillary mucinous neoplasm of the pancreas
  • mucinous cystic neoplasm
  • pancreatic exocrine neoplasia
  • Neoplasms
  • Pancreatic Neoplasms

Name

Location

H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612