Bladder Cancer Clinical Trial

Chemotherapy in Treating Patients With Early-Stage Bladder Cancer

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.

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Full 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.

View Eligibility Criteria

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

Study is for people with:

Bladder Cancer

Phase:

Phase 2

Estimated Enrollment:

75

Study ID:

NCT00003129

Recruitment Status:

Completed

Sponsor:

Eastern Cooperative Oncology Group

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There are 10 Locations for this study

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H. Lee Moffitt Cancer Center and Research Institute
Tampa Florida, 33612, United States
CCOP - Carle Cancer Center
Urbana Illinois, 61801, United States
Veterans Affairs Medical Center - East Orange
East Orange New Jersey, 07018, United States
Fox Chase Cancer Center
Philadelphia Pennsylvania, 19111, United States
CCOP - MainLine Health
Wynnewood Pennsylvania, 19096, United States
CCOP - Green Bay
Green Bay Wisconsin, 54301, United States
Veterans Affairs Medical Center - Madison
Madison Wisconsin, 53705, United States
University of Wisconsin Comprehensive Cancer Center
Madison Wisconsin, 53792, United States
Medical College of Wisconsin
Milwaukee Wisconsin, 53226, United States
Veterans Affairs Medical Center - Milwaukee (Zablocki)
Milwaukee Wisconsin, 53295, United States

How clear is this clinincal trial information?

Study is for people with:

Bladder Cancer

Phase:

Phase 2

Estimated Enrollment:

75

Study ID:

NCT00003129

Recruitment Status:

Completed

Sponsor:


Eastern Cooperative Oncology Group

How clear is this clinincal trial information?

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