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Phase III Randomized, Double-Blind Study of DFMO vs. Placebo in Low Grade Superficial Bladder Cancer

Phase 3
18 Years
Not Enrolling
Bladder Cancer

Thank you

Trial Information

Phase III Randomized, Double-Blind Study of DFMO vs. Placebo in Low Grade Superficial Bladder Cancer

OBJECTIVES: I. Determine whether treatment with eflornithine is effective in preventing
recurrence of tumor after transurethral resection in patients with low grade, superficial
transitional cell carcinoma of the bladder. II. Determine the incidence and severity of
toxicities associated with the long-term use of this drug in this patient population.

OUTLINE: This is a randomized, double blind, multicenter study. Patients are stratified
according to disease status (newly diagnosed vs recurrent), clinical stage (Ta vs T1), grade
(G1 vs G2), and focus (multifocal vs unifocal). Patients receive either oral eflornithine or
placebo once daily. Treatment continues for 1 year in the absence of disease progression or
unacceptable toxicity. Patients are followed every 3 months during the first 2 years, every
6 months for the third year, and then annually for the fourth year.

PROJECTED ACCRUAL: A total of 450 patients (225 per arm) will be accrued to this study
within 1.5 years.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed low grade (grade 1 or 2), superficial
(stage Ta or T1) transitional cell carcinoma (TCC) of the bladder Newly diagnosed or
recurrent All visible tumor must have been resected within the past 12 weeks Standard
clinical management determined to be expectant observation without further surgery,
intravesical therapy, or systemic therapy No prior upper tract TCC No history of grade 3
TCC, carcinoma in situ including severe dysplasia, non-TCC histology, or TCC greater than
or equal to T2 No involvement of upper urinary tract prior to or at the time of initial
tumor resection Abdominal CT scan, IVP, or retrograde pyelogram within the past 3 months
to rule out upper urinary tract tumor

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Life
expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not
specified Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use
effective contraception No prior malignancy within the past 5 years and no concurrent
malignancy except nonmelanomatous skin cancer or carcinoma in situ of the cervix No
clinically significant hearing loss (i.e., hearing loss effects everyday life and/or wears
a hearing aide) No other significant medical or psychiatric condition

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior growth factors No
concurrent growth factors Chemotherapy: No prior systemic chemotherapy for bladder cancer
No concurrent intravesical therapy At least 4 weeks since prior chemotherapy No concurrent
chemotherapy Endocrine therapy: At least 4 weeks since prior high dose steroids or
prednisone No concurrent high dose steroids No concurrent prednisone or its equivalent in
excess of 10 mg/day Radiotherapy: No prior radiotherapy for bladder cancer At least 4
weeks since prior radiotherapy No concurrent radiotherapy Surgery: See Disease
Characteristics Other: At least 4 weeks since prior carbamazepine or experimental drugs No
concurrent carbamazepine or experimental drugs

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Mark Mayle

Investigator Role:

Study Chair

Investigator Affiliation:



United States: Federal Government

Study ID:




Start Date:

February 1999

Completion Date:

Related Keywords:

  • Bladder Cancer
  • stage 0 bladder cancer
  • stage I bladder cancer
  • recurrent bladder cancer
  • transitional cell carcinoma of the bladder
  • Urinary Bladder Neoplasms



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