NCT00004154

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as fenretinide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether fenretinide is more effective than a placebo in preventing the recurrence of bladder cancer after surgery to remove the tumor. PURPOSE: This randomized phase III trial is studying fenretinide to see how well it works compared to a placebo in treating patients who are at risk for recurrent bladder cancer following surgery to remove the tumor.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
111

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jul 1998

Longer than P75 for phase_3

Geographic Reach
1 country

3 active sites

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

July 30, 1998

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

December 10, 1999

Completed
3.1 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed
Last Updated

November 8, 2018

Status Verified

November 1, 2018

Enrollment Period

6.6 years

First QC Date

December 10, 1999

Last Update Submit

November 7, 2018

Conditions

Bladder Cancer

Keywords

stage 0 bladder cancerstage I bladder cancertransitional cell carcinoma of the bladder

Outcome Measures

Primary Outcomes (1)

  • Recurrence rate of transitional cell carcinoma (TCC)

    Recurrence rates is defined as proportion of participants who recur within one year of surgery.

    1 year

Study Arms (2)

Fenretinide

EXPERIMENTAL

Fenretinide (4-HPR) 200 mg orally every day for 12 months taken 25 out of every 28 days.

Drug: Fenretinide

Placebo

PLACEBO COMPARATOR

Placebo orally every day for 12 months, taken 25 out of every 28 days.

Other: Placebo

Interventions

FenretinideDRUG

200 mg/day (two 100 mg capsules) for 25 days of 28 day cycle.

Also known as: 4-HPR
Fenretinide
PlaceboOTHER

Two placebo capsules for 25 days of 28 day cycle.

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically proven solitary or multifocal superficial (stage Ta, grades 1-2) transitional cell carcinoma (TCC) of the bladder meeting 1 of the following criteria: * Newly diagnosed and no more than 4 weeks since resection * Secondary after being tumor free (including carcinoma in situ) for more than 12 months with no intravesical therapy within that 12 months OR * Histologically proven Ta, T1, or Tis TCC of the bladder previously treated with Bacillus Calmette-Guerin (BCG). * Must have received 6 weeks of induction BCG followed by no evidence of disease by cystoscopy and cytology and then further treatment with 3 weekly doses of BCG. * Visible tumor totally resected within 4 weeks prior to study entry and no further surgery, intravesical therapy, or systemic therapy planned * No prostatic, prostatic urethral, or upper tract TCC involvement by the index tumor at resection * No metastatic disease PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Zubrod (Eastern Cooperative Oncology Group (ECOG)) 0-2 Life expectancy: * At least 2 years Hematopoietic: * white blood count (WBC) greater than 3,000/mm\^3 * Platelet count greater than 100,000/mm\^3 * Hemoglobin greater than 11.0 g/dL Hepatic: * serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic pyruvic transaminase (SGPT) less than 1.5 times upper limit of normal (ULN) Renal: * Creatinine less than 2.0 mg/dL Other: * Triglyceride level less than 2.5 times ULN * No other concurrent malignancy except nonmelanomatous skin cancer * No other malignancy within the past 5 years unless currently disease free, at least 6 months since prior therapy, no current or planned active therapy, and expected disease-free survival at least 2 years * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 1 year after the study participation PRIOR CONCURRENT THERAPY: Biologic therapy: * See Disease Characteristics * No concurrent systemic biologic therapy Chemotherapy: * See Disease Characteristics * No prior systemic cytotoxic chemotherapy for bladder cancer * At least 1 year since prior cytotoxic chemotherapy for nonbladder cancer * No concurrent systemic chemotherapy Endocrine therapy: * Not specified Radiotherapy: * No prior radiotherapy to the bladder * No concurrent radiotherapy Surgery: * See Disease Characteristics Other: * At least 3 months since prior high-dose vitamin A (greater than 25,000 IU) or beta carotene (at least 30 mg/day) * At least 3 months since prior retinoid therapy

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

Sponsors & Collaborators

Study Sites (3)

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Veterans Affairs Medical Center - Seattle

Seattle, Washington, 98108, United States

Location

Related Publications (1)

  • Sabichi AL, Lerner SP, Atkinson EN, Grossman HB, Caraway NP, Dinney CP, Penson DF, Matin S, Kamat A, Pisters LL, Lin DW, Katz RL, Brenner DE, Hemstreet GP 3rd, Wargo M, Bleyer A, Sanders WH, Clifford JL, Parnes HL, Lippman SM. Phase III prevention trial of fenretinide in patients with resected non-muscle-invasive bladder cancer. Clin Cancer Res. 2008 Jan 1;14(1):224-9. doi: 10.1158/1078-0432.CCR-07-0733.

    PMID: 18172274RESULT

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Fenretinide

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

RetinoidsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicTerpenesPigments, BiologicalBiological Factors

Study Officials

  • Anita L. Sabichi, MD

    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
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 1999

First Posted

January 27, 2003

Study Start

July 30, 1998

Primary Completion

March 1, 2005

Study Completion

March 1, 2005

Last Updated

November 8, 2018

Record last verified: 2018-11

Locations

US(3)