Chemotherapy in Treating Patients With Early-Stage Bladder Cancer

Bladder Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003129
• Other study ID #: CDR0000065892
• Secondary ID: E-3897
• Status: Completed
• Phase: Phase 2
• Start date: September 1, 1998
• Est. completion date: May 1, 2009

Study information

• Verified date: June 2023
• Source: Eastern Cooperative Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: May 1, 2009
• Est. primary completion date: November 2002
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Drug:
• valrubicin

Locations

Country	Name	City	State
United States	Veterans Affairs Medical Center - East Orange	East Orange	New Jersey
United States	CCOP - Green Bay	Green Bay	Wisconsin
United States	University of Wisconsin Comprehensive Cancer Center	Madison	Wisconsin
United States	Veterans Affairs Medical Center - Madison	Madison	Wisconsin
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Veterans Affairs Medical Center - Milwaukee (Zablocki)	Milwaukee	Wisconsin
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida
United States	CCOP - Carle Cancer Center	Urbana	Illinois
United States	CCOP - MainLine Health	Wynnewood	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Eastern Cooperative Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 ( — View Citation