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Fenretinide in Treating Patients Who Have Undergone Surgery for Bladder Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00004154
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : November 8, 2018
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.

Condition or disease Intervention/treatment Phase
Bladder Cancer Drug: Fenretinide Other: Placebo Phase 3

Detailed Description:


  • Determine the efficacy, mechanism of action, and toxicity of fenretinide in patients at risk of recurrent superficial bladder cancer after complete resection of initial tumor.
  • Determine the treatment effects in modulating the expression of retinoid receptors, chromosomal abnormalities (numerical chromosomal abnormalities and DNA ploidy), apoptosis, and autocrine motility factor receptor (intermediate endpoint markers of recurrent disease) in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to lesion type (multifocal vs solitary). Patients are randomized to one of two treatment arms.

Patients receive either oral fenretinide or placebo on days 1-25. Courses repeat every 28 days for up to 1 year in the absence of disease progression, unacceptable toxicity, or development of a second primary cancer requiring therapy.

Patients are followed every 3 months for 15 months.

PROJECTED ACCRUAL: A total of 178 patients (89 per arm) will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 111 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Randomized Chemoprevention Trial With 4-HPR (Fenretinide) in Superficial Bladder Cancer
Actual Study Start Date : July 30, 1998
Actual Primary Completion Date : March 1, 2005
Actual Study Completion Date : March 1, 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Arm Intervention/treatment
Experimental: Fenretinide
Fenretinide (4-HPR) 200 mg orally every day for 12 months taken 25 out of every 28 days.
Drug: Fenretinide
200 mg/day (two 100 mg capsules) for 25 days of 28 day cycle.
Other Name: 4-HPR

Placebo Comparator: Placebo
Placebo orally every day for 12 months, taken 25 out of every 28 days.
Other: Placebo
Two placebo capsules for 25 days of 28 day cycle.

Primary Outcome Measures :
  1. Recurrence rate of transitional cell carcinoma (TCC) [ Time Frame: 1 year ]
    Recurrence rates is defined as proportion of participants who recur within one year of surgery.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status:

  • Zubrod (Eastern Cooperative Oncology Group (ECOG)) 0-2

Life expectancy:

  • At least 2 years


  • 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


  • serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic pyruvic transaminase (SGPT) less than 1.5 times upper limit of normal (ULN)


  • Creatinine less than 2.0 mg/dL


  • 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


Biologic therapy:

  • See Disease Characteristics
  • No concurrent systemic biologic therapy


  • 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


  • No prior radiotherapy to the bladder
  • No concurrent radiotherapy


  • See Disease Characteristics


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00004154

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United States, Texas
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
Baylor College of Medicine
Houston, Texas, United States, 77030
United States, Washington
Veterans Affairs Medical Center - Seattle
Seattle, Washington, United States, 98108
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
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Study Chair: Anita L. Sabichi, MD M.D. Anderson Cancer Center

Publications of Results:
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Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00004154     History of Changes
Other Study ID Numbers: CDR0000067387
ID95-236 ( Other Identifier: UT MD Anderson Cancer Center )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: November 8, 2018
Last Verified: November 2018
Keywords provided by M.D. Anderson Cancer Center:
stage 0 bladder cancer
stage I bladder cancer
transitional cell carcinoma of the bladder
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases