Clinical trial NCT00003129: Chemotherapy in Treating Patients With Early-Stage Bladder Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Bladder Cancer
Keywords: stage 0 bladder cancer
stage I bladder cancer
transitional cell carcinoma of the bladder
Lead sponsor: Eastern Cooperative Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-04-18
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
city: Urbana
country: United States
facility: CCOP - Carle Cancer Center
state: Illinois
city: East Orange
country: United States
facility: Veterans Affairs Medical Center - East Orange
state: New Jersey
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Wynnewood
country: United States
facility: CCOP - MainLine Health
state: Pennsylvania
city: Green Bay
country: United States
facility: CCOP - Green Bay
state: Wisconsin
city: Madison
country: United States
facility: Veterans Affairs Medical Center - Madison
state: Wisconsin
city: Madison
country: United States
facility: University of Wisconsin Comprehensive Cancer Center
state: Wisconsin
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Milwaukee
country: United States
facility: Veterans Affairs Medical Center - Milwaukee (Zablocki)
state: Wisconsin
Study officials:
affiliation: Endeavor Health
name: Jeffrey M. Ignatoff, MD
role: STUDY_CHAIR
References:
citation: 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.