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

Pancreatic Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00985777
• Other study ID #: MCC-15630
• Secondary ID: 1R01CA129227-01A
• Status: Completed
• Phase: Phase 1
• First received: September 25, 2009
• Last updated: February 29, 2016
• Start date: September 2009
• Est. completion date: February 2016

Study information

• Verified date: February 2016
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: February 2016
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Pancreatic Neoplasms

Intervention

Drug:
• Vitamin E d-Tocotrienol
Vitamin E d-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.

Locations

Country	Name	City	State
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Tolerated Dose (MTD)	To determine the recommended Phase II dose of Vitamin E d-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 d-Tocotrienol twice daily for 14 (± 2)days prior to surgery, and one dose the day of surgery.	12 weeks per participant	No
Secondary	Number of Participants With Adverse Events (AEs)	To characterize the safety and tolerability of Vitamin E d-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.	12 weeks per participant	Yes

External Links

•   Moffitt Cancer Center Clinical Trials website