Chemotherapy in Treating Patients With Early-Stage 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: NCT00003129
Recruitment Status : Completed
First Posted : April 18, 2003
Last Update Posted : June 9, 2009
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of chemotherapy in treating patients with early-stage bladder cancer that has not responded to BCG therapy.

Condition or disease Intervention/treatment Phase
Bladder Cancer Drug: valrubicin Phase 2

Detailed Description:


  • Determine the recurrence rate and disease free survival in patients with recurrent or refractory papillary transitional cell carcinoma of the bladder with or without carcinoma in situ of the bladder treated with intravesical AD 32.
  • Evaluate the safety of administering this drug in these patients.
  • Determine the effectiveness of this drug, in terms of recurrence rates and disease free survival, in these patients.

OUTLINE: Patients are stratified according to cellular diagnosis (papillary transitional cell carcinoma (Ta/T1) with no carcinoma in situ (Tis) vs Tis with or without Ta/T1).

Patients receive intravesical AD 32 once a week for 6 weeks.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 75 patients will be accrued for this study.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Primary Purpose: Treatment
Official Title: Phase II Study of Intravesical Therapy With AD 32 in Patients With Papillary Urothelial Carcinoma or Carcinoma in Situ (CIS) Refractory to Prior Therapy With Bacillus Calmette-Guerin
Study Start Date : July 1998
Actual Primary Completion Date : November 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer
Drug Information available for: Valrubicin

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 confirmed recurrent superficial bladder cancer defined as papillary transitional cell carcinoma (stage Ta/T1) and/or carcinoma in situ (stage Tis) of the urinary bladder

    • No evidence of invasion of the underlying muscle (stage T2) at baseline
  • Must meet 1 of the following criteria:

    • Failure of at least 2 prior courses of intravesical therapy, 1 of which must have been a course of BCG
    • Recurrent or persistent disease within 6 months after failing a 6-week course of BCG followed by maintenance therapy
    • Inability or ineligibility to complete 1 course of intravesical therapy with BCG, and failure of 2 prior courses of intravesical therapy with an alternative agent
  • Diagnosis must have been made no more than 24 months after completion of prior treatment with intravesical immunotherapy or chemotherapy
  • If carcinoma in situ is current or previous diagnosis, the biopsies must be obtained from at least 4 sites (bladder mapping)
  • If prostatic urothelial biopsy discloses carcinoma in situ, transurethral prostatic resection must be carried out prior to study
  • Papillary disease must have undergone complete transurethral resection (TURBT) within 28 days before study



  • 18 and over

Performance status:

  • ECOG 0-1

Life expectancy:

  • Not specified


  • WBC greater than 4,000/mm^3
  • Platelet count greater than 100,000/mm^3


  • Bilirubin less than 2 times upper limit of normal (ULN)
  • SGOT and SGPT less than 3 times ULN


  • Creatinine no greater than 2.5 mg/dL


  • Normal upper tract (ureter and renal pelvic) evaluation within 6 months
  • No known sensitivity to anthracyclines or to Cremophor EL
  • HIV negative
  • No known AIDS or HIV-1 associated complex
  • No other significant concurrent illness
  • No other prior malignancy within the past 3 years except superficial bladder cancer, adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix
  • Not pregnant or nursing
  • Fertile patients must use effective contraception


Biologic therapy:

  • See Disease Characteristics
  • No concurrent biological response modifier therapy


  • See Disease Characteristics
  • Prior oral bropirimine for bladder cancer allowed
  • No prior AD 32 for bladder cancer
  • No other intravenously administered systemic chemotherapy for bladder cancer
  • No concurrent chemotherapy for any other malignancy

Endocrine therapy:

  • No concurrent hormonal therapy


  • No prior radiotherapy
  • No concurrent radiotherapy


  • See Disease Characteristics

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): NCT00003129

United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612-9497
United States, Illinois
CCOP - Carle Cancer Center
Urbana, Illinois, United States, 61801
United States, New Jersey
Veterans Affairs Medical Center - East Orange
East Orange, New Jersey, United States, 07018-1095
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
CCOP - MainLine Health
Wynnewood, Pennsylvania, United States, 19096
United States, Wisconsin
CCOP - Green Bay
Green Bay, Wisconsin, United States, 54301
Veterans Affairs Medical Center - Madison
Madison, Wisconsin, United States, 53705
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-6164
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Veterans Affairs Medical Center - Milwaukee (Zablocki)
Milwaukee, Wisconsin, United States, 53295
Sponsors and Collaborators
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Study Chair: Jeffrey M. Ignatoff, MD NorthShore University HealthSystem Research Institute

Publications of Results: Identifier: NCT00003129     History of Changes
Other Study ID Numbers: CDR0000065892
First Posted: April 18, 2003    Key Record Dates
Last Update Posted: June 9, 2009
Last Verified: January 2002

Keywords provided by National Cancer Institute (NCI):
stage 0 bladder cancer
stage I bladder cancer
transitional cell carcinoma of the bladder

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action