NCT00003075

Brief Summary

RATIONALE: Chemoprevention uses drugs to try and prevent development of cancer. Fenretinide may be effective in treating cervical neoplasia and preventing cervical cancer. PURPOSE: Randomized double-blinded phase III trial to compare the effectiveness of fenretinide to placebo in treating patients with cervical neoplasia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
39

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 1993

Longer than P75 for phase_3

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

March 5, 1993

Completed
6.7 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2001

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2001

Completed
3.1 years until next milestone

First Posted

Study publicly available on registry

May 27, 2004

Completed
Last Updated

October 24, 2018

Status Verified

October 1, 2018

Enrollment Period

8.2 years

First QC Date

November 1, 1999

Last Update Submit

October 23, 2018

Conditions

Cervical CancerPrecancerous Condition

Keywords

cervical cancercervical intraepithelial neoplasia grade 2cervical intraepithelial neoplasia grade 3

Outcome Measures

Primary Outcomes (1)

  • Efficacy of Fenretinide at Regressing CIN

    6 months

Study Arms (2)

Fenretinide

EXPERIMENTAL
Drug: Fenretinide

Placebo

PLACEBO COMPARATOR
Other: Placebo

Interventions

FenretinideDRUG

Oral Fenretinide daily for 6 months with 3 days of rest every month.

Also known as: 4-HPR
Fenretinide
PlaceboOTHER

Oral placebo daily for 6 months with 3 days of rest every month.

Placebo

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically diagnosed new or recurrent cervical intraepithelial neoplasia grade 2-3 lesion involving at least one quadrant of the transformation zone of the cervix PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-2 Life expectancy: At least 12 months Hematopoietic: Absolute granulocyte count greater than 1500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 1.5 mg/dL Other: Fertile patients must use effective contraception Fasting triglyceride less than 2 times normal No prior malignancy Must consent to colposcopy and cervical biopsy PRIOR CONCURRENT THERAPY: Not specified

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Uterine Cervical NeoplasmsPrecancerous ConditionsUterine Cervical Dysplasia

Interventions

Fenretinide

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

RetinoidsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicTerpenesPigments, BiologicalBiological Factors

Study Officials

  • Michele Follen, MD, PhD

    M.D. Anderson Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

May 27, 2004

Study Start

March 5, 1993

Primary Completion

May 1, 2001

Study Completion

May 1, 2001

Last Updated

October 24, 2018

Record last verified: 2018-10

Locations

US(1)