Chemotherapy in Treating Patients With Early-Stage Bladder Cancer (NCT00003129) | Clinical Trial Compass
CompletedPhase 2
Chemotherapy in Treating Patients With Early-Stage Bladder Cancer
United States75 participantsStarted 1998-09-01
Plain-language 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.
Who can participate
Age range18 Years – 120 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 norm…