NCT00433576

Brief Summary

This phase I trial is studying the side effects and best dose of resveratrol in treating patients with colorectal cancer that can be removed by surgery. Resveratrol may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Dec 2006

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 8, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 12, 2007

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

September 15, 2014

Status Verified

October 1, 2011

Enrollment Period

1.9 years

First QC Date

February 8, 2007

Last Update Submit

September 12, 2014

Conditions

Adenocarcinoma of the ColonAdenocarcinoma of the RectumStage I Colon CancerStage I Rectal CancerStage II Colon CancerStage II Rectal CancerStage III Colon CancerStage III Rectal Cancer

Outcome Measures

Primary Outcomes (2)

  • Pharmacodynamics of resveratrol

    Up to 8 days

  • Concentrations of biomarkers

    Up to day 9

Study Arms (1)

Treatment (resveratrol, colorectomy)

EXPERIMENTAL

STAGE I: Patients undergo an colorectal endoscopy. Patients whose biopsies confirm colorectal adenocarcinoma histology and require surgical resection continue on study stage 2. STAGE II: Patients receive oral resveratrol on days 1-8. Patients undergo colorectomy on day 9. A tumor biopsy is performed during endoscopy and colorectomy for research purposes.

Drug: resveratrolOther: pharmacological studyOther: laboratory biomarker analysis

Interventions

resveratrolDRUG

Given orally

Treatment (resveratrol, colorectomy)
pharmacological studyOTHER

Correlative studies

Also known as: pharmacological studies
Treatment (resveratrol, colorectomy)
laboratory biomarker analysisOTHER

Correlative studies

Treatment (resveratrol, colorectomy)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Stage 1:
  • Radiological or clinical evidence of a colorectal malignancy
  • Requires colorectal endoscopy for diagnosis
  • Stage 2:
  • Histologically confirmed adenocarcinoma of the colon or rectum by colorectal endoscopy in stage 1 study
  • Resectable disease
  • Planning to undergo colorectomy
  • WHO performance status 0-2
  • ALT ≤ 2.5 times upper limit of normal (ULN)
  • Bilirubin ≤ 1.5 times ULN
  • Creatinine ≤ 1.5 mg/dL
  • Hemoglobin ≥ 10 g/dL (transfusion allowed for anemia due to bleeding from the tumor)
  • Suitable for general anesthesia
  • No active peptic ulcer disease
  • Not pregnant or nursing
  • +13 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Colonic NeoplasmsRectal Neoplasms

Interventions

Resveratrol

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

StilbestrolsStilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolyphenolsPhenols

Study Officials

  • Dean Brenner

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2007

First Posted

February 12, 2007

Study Start

December 1, 2006

Primary Completion

November 1, 2008

Study Completion

March 1, 2009

Last Updated

September 15, 2014

Record last verified: 2011-10

Locations

US(1)