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

This study is currently recruiting participants.
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

September 25, 2009
April 3, 2014
September 2009
December 2014   (final data collection date for primary outcome measure)
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.
Determine the recommended Phase II dose of, and characterize the safety and tolerability of Vitamin E δ-Tocotrienol. [ Time Frame: 12 weeks per participant ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00985777 on ClinicalTrials.gov Archive Site
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.
  • Determine the plasma pharmacokinetic (PK) and estimate renal elimination of Vitamin E δ-Tocotrienol and its putative metabolite. [ Time Frame: 12 weeks per participant ] [ Designated as safety issue: Yes ]
  • Evaluate the pharmacodynamic (PD) correlation of Vitamin E δ-Tocotrienol activity in peripheral blood, pancreatic tumor, and pancreas tissue in subjects with pancreatic neoplasia. [ Time Frame: 12 weeks per participant ] [ Designated as safety issue: Yes ]
  • Determine the bioavailability of Vitamin E δ-Tocotrienol in normal and neoplastic pancreatic tissue. [ Time Frame: 12 weeks per participant ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Vitamin E δ-Tocotrienol Administered to Subjects With Resectable Pancreatic Exocrine Neoplasia
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

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.

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.

Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Pancreatic Neoplasms
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
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.
Intervention: Drug: Vitamin E δ-Tocotrienol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
45
December 2014
December 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Gregory Springett, M.D., Ph.D. 813-745-6898 gregory.springett@moffitt.org
Contact: Helen Jump 813-745-4834 helen.jump@moffitt.org
United States
 
NCT00985777
MCC-15630, 1R01CA129227-01A1
Yes
H. Lee Moffitt Cancer Center and Research Institute
H. Lee Moffitt Cancer Center and Research Institute
National Cancer Institute (NCI)
Principal Investigator: Gregory Springett, M.D., Ph.D. H. Lee Moffitt Cancer Center and Research Institute
H. Lee Moffitt Cancer Center and Research Institute
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP