Vitamin E δ-Tocotrienol Administered to Subjects With Resectable Pancreatic Exocrine Neoplasia

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by H. Lee Moffitt Cancer Center and Research Institute
Sponsor:
Collaborator:
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier:
NCT00985777
First received: September 25, 2009
Last updated: April 3, 2014
Last verified: April 2014
  Purpose

The purpose of this study is to determine the safest dose of the study drug Vitamin E Delta-tocotrienol, how often it should be taken, and how well people with pancreatic tumors tolerate Vitamin E Delta-tocotrienol.


Condition Intervention Phase
Pancreatic Neoplasms
Drug: Vitamin E δ-Tocotrienol
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by H. Lee Moffitt Cancer Center and Research Institute:

Primary Outcome Measures:
  • Maximum Tolerated Dose (MTD) [ Time Frame: 12 weeks per participant ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Number of Participants With Adverse Events (AEs) [ Time Frame: 12 weeks per participant ] [ Designated as safety issue: Yes ]
    To characterize the safety and tolerability of Vitamin E δ-Tocotrienol when orally administered at up to 5.6 times the predicted biological effective dose (1600mg twice daily) for 14 (± 2) consecutive days and one dose the day of surgery in patients with pancreatic neoplasia.


Estimated Enrollment: 45
Study Start Date: September 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Phase I Dose Escalation
Vitamin E δ-Tocotrienol will be administered orally as a single agent twice daily for 14 consecutive days and one dose on Day 15.
Drug: Vitamin E δ-Tocotrienol
Vitamin E δ-Tocotrienol is supplied as 100-mg, 200-mg, and 400-mg capsules. The investigator (or designee) will have records of the number of participants treated within a specific cohort and will determine which treatment cohort to assign newly enrolled participants.
Other Name: Delta-tocotrienol

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00985777

Contacts
Contact: Gregory Springett, M.D., Ph.D. 813-745-6898 gregory.springett@moffitt.org
Contact: Helen Jump 813-745-4834 helen.jump@moffitt.org

Locations
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute Recruiting
Tampa, Florida, United States, 33612
Contact: Gregory Springett, M.D., Ph.D.    813-745-6898    gregory.springett@moffitt.org   
Contact: Helen Jump    813-745-4834    helen.jump@moffitt.org   
Principal Investigator: Gregory Springett, M.D., Ph.D.         
Sub-Investigator: Pamela Hodul, M.D.         
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
Investigators
Principal Investigator: Gregory Springett, M.D., Ph.D. H. Lee Moffitt Cancer Center and Research Institute
  More Information

Additional Information:
No publications provided

Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT00985777     History of Changes
Other Study ID Numbers: MCC-15630, 1R01CA129227-01A1
Study First Received: September 25, 2009
Last Updated: April 3, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
pancreas
resectable
pancreatic tumor
pancreatic ductal adenocarcinoma
intraductal papillary mucinous neoplasm of the pancreas
mucinous cystic neoplasm
pancreatic exocrine neoplasia

Additional relevant MeSH terms:
Vitamin E
Alpha-Tocopherol
Tocopherols
Tocotrienols
Neoplasms
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Vitamins
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on August 19, 2014