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

NCT00985777 | Completed Phase 1 DMC

• 2 other identifiers: MCC-156301R01CA129227-01A1
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pancreatic Neoplasms

Keywords

pancreas; resectable; pancreatic tumor; pancreatic ductal adenocarcinoma; intraductal papillary mucinous neoplasm of the pancreas; mucinous cystic neoplasm; pancreatic exocrine neoplasia

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose (MTD)

  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.

  12 weeks per participant

Secondary Outcomes (1)

• Number of Participants With Adverse Events (AEs)

  12 weeks per participant

Study Arms (1)

Phase I Dose Escalation

EXPERIMENTAL

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

Interventions

Vitamin E δ-Tocotrienol DRUG

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.

Also known as: Delta-tocotrienol

Phase I Dose Escalation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

Related Publications (1)

• Springett GM, Husain K, Neuger A, Centeno B, Chen DT, Hutchinson TZ, Lush RM, Sebti S, Malafa MP. A Phase I Safety, Pharmacokinetic, and Pharmacodynamic Presurgical Trial of Vitamin E delta-tocotrienol in Patients with Pancreatic Ductal Neoplasia. EBioMedicine. 2015 Nov 14;2(12):1987-95. doi: 10.1016/j.ebiom.2015.11.025. eCollection 2015 Dec.

  PMID: 26844278 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms; Pancreatic Intraductal Neoplasms

Interventions

tocotrienol, delta

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Neoplasms, Ductal, Lobular, and Medullary; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Gregory Springett, M.D., Ph.D.

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2009
• First Posted: September 28, 2009
• Study Start: September 1, 2009
• Primary Completion: June 1, 2015
• Study Completion: February 1, 2016
• Last Updated: March 1, 2016

Record last verified: 2016-02

Locations

US (1)