Chemotherapy in Treating Patients With Early-Stage Bladder Cancer

• Status: Completed
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eastern Cooperative Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Valrubicin

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