Chemotherapy in Treating Patients With Early-Stage Bladder Cancer

NCT00003129 | Completed Phase 2

• 2 other identifiers: CDR0000065892E-3897
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 10

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.

Conditions

Bladder Cancer

Keywords

stage 0 bladder cancer; stage I bladder cancer; transitional cell carcinoma of the bladder

Interventions

valrubicin DRUG

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Eastern Cooperative Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (10)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612-9497, United States

Location

CCOP - Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

Veterans Affairs Medical Center - East Orange

East Orange, New Jersey, 07018-1095, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

CCOP - MainLine Health

Wynnewood, Pennsylvania, 19096, United States

Location

CCOP - Green Bay

Green Bay, Wisconsin, 54301, United States

Location

Veterans Affairs Medical Center - Madison

Madison, Wisconsin, 53705, United States

Location

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, 53792-6164, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Veterans Affairs Medical Center - Milwaukee (Zablocki)

Milwaukee, Wisconsin, 53295, United States

Location

Related 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 (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.

  PMID: 18639470 RESULT

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

valrubicin

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Jeffrey M. Ignatoff, MD

  Endeavor Health

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: April 18, 2003
• Study Start: September 1, 1998
• Primary Completion: November 1, 2002
• Study Completion: May 1, 2009
• Last Updated: June 22, 2023

Record last verified: 2023-06

Locations

US (10)