Fenretinide in Treating Patients Who Have Undergone Surgery for Bladder Cancer (NCT00004154) | Clinical Trial Compass
CompletedPhase 3
Fenretinide in Treating Patients Who Have Undergone Surgery for Bladder Cancer
United States111 participantsStarted 1998-07-30
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 t…
What they're measuring
1
Recurrence rate of transitional cell carcinoma (TCC)