Chemotherapy in Treating Patients With Early-Stage Bladder Cancer

NCT ID: NCT00003129

Last Updated: 2023-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-09-01
• Study Completion Date: 2009-05-01

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.

Conditions

Bladder Cancer

Study Design

• Primary Study Purpose: TREATMENT

Interventions

valrubicin

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Eastern Cooperative Oncology Group

NETWORK

Sponsor Role: lead

Principal Investigators

Jeffrey M. Ignatoff, MD

Role: STUDY_CHAIR

Endeavor Health

Locations

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

CCOP - Carle Cancer Center

Urbana, Illinois, United States

Veterans Affairs Medical Center - East Orange

East Orange, New Jersey, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

CCOP - MainLine Health

Wynnewood, Pennsylvania, United States

CCOP - Green Bay

Green Bay, Wisconsin, United States

Veterans Affairs Medical Center - Madison

Madison, Wisconsin, United States

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Veterans Affairs Medical Center - Milwaukee (Zablocki)

Milwaukee, Wisconsin, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 18639470 (View on PubMed)

Other Identifiers

E-3897

Identifier Type: -

Identifier Source: secondary_id

CDR0000065892

Identifier Type: -

Identifier Source: org_study_id