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Chemotherapy in Treating Patients With Early-Stage Bladder Cancer

Primary Purpose

Bladder Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
valrubicin
Sponsored by
Eastern Cooperative Oncology Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bladder Cancer focused on measuring stage 0 bladder cancer, stage I bladder cancer, transitional cell carcinoma of the bladder

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: 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 PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: WBC greater than 4,000/mm^3 Platelet count greater than 100,000/mm^3 Hepatic: Bilirubin less than 2 times upper limit of normal (ULN) SGOT and SGPT less than 3 times ULN Renal: Creatinine no greater than 2.5 mg/dL Other: 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 PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics No concurrent biological response modifier therapy Chemotherapy: 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 Radiotherapy: No prior radiotherapy No concurrent radiotherapy Surgery: See Disease Characteristics

Sites / Locations

  • H. Lee Moffitt Cancer Center and Research Institute
  • CCOP - Carle Cancer Center
  • Veterans Affairs Medical Center - East Orange
  • Fox Chase Cancer Center
  • CCOP - MainLine Health
  • CCOP - Green Bay
  • Veterans Affairs Medical Center - Madison
  • University of Wisconsin Comprehensive Cancer Center
  • Medical College of Wisconsin
  • Veterans Affairs Medical Center - Milwaukee (Zablocki)

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
June 20, 2023
Sponsor
Eastern Cooperative Oncology Group
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00003129
Brief Title
Chemotherapy in Treating Patients With Early-Stage Bladder Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 1998 (Actual)
Primary Completion Date
November 2002 (Actual)
Study Completion Date
May 1, 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Eastern Cooperative Oncology Group
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.
Detailed Description
OBJECTIVES: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer
Keywords
stage 0 bladder cancer, stage I bladder cancer, transitional cell carcinoma of the bladder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
valrubicin

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: 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 PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: WBC greater than 4,000/mm^3 Platelet count greater than 100,000/mm^3 Hepatic: Bilirubin less than 2 times upper limit of normal (ULN) SGOT and SGPT less than 3 times ULN Renal: Creatinine no greater than 2.5 mg/dL Other: 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 PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics No concurrent biological response modifier therapy Chemotherapy: 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 Radiotherapy: No prior radiotherapy No concurrent radiotherapy Surgery: See Disease Characteristics
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey M. Ignatoff, MD
Organizational Affiliation
NorthShore University HealthSystem
Official's Role
Study Chair
Facility Information:
Facility Name
H. Lee Moffitt Cancer Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612-9497
Country
United States
Facility Name
CCOP - Carle Cancer Center
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
Veterans Affairs Medical Center - East Orange
City
East Orange
State/Province
New Jersey
ZIP/Postal Code
07018-1095
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
CCOP - MainLine Health
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
Facility Name
CCOP - Green Bay
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54301
Country
United States
Facility Name
Veterans Affairs Medical Center - Madison
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
Facility Name
University of Wisconsin Comprehensive Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792-6164
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Veterans Affairs Medical Center - Milwaukee (Zablocki)
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53295
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18639470
Citation
Ignatoff JM, Chen YH, Greenberg RE, Pow-Sang JM, Messing EM, Wilding G. Phase II study of intravesical therapy with AD32 in patients with papillary urothelial carcinoma or carcinoma in situ (CIS) refractory to prior therapy with bacillus Calmette-Guerin (E3897): a trial of the Eastern Cooperative Oncology Group. Urol Oncol. 2009 Sep-Oct;27(5):496-501. doi: 10.1016/j.urolonc.2008.05.004. Epub 2008 Jul 17.
Results Reference
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Chemotherapy in Treating Patients With Early-Stage Bladder Cancer

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