Phase 2 N=58 Treatment

S0353, Gemcitabine in Treating Patients With Recurrent Bladder Cancer That Has Not Responded to Previous Bacillus Calmette-Guerin

Bladder Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00234039 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2012

Primary outcome: Primary: Complete Response Rate at the End of Induction — 46 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: gemcitabine hydrochloride (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: SWOG Cancer Research Network
Primary completion: Nov 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Complete Response Rate at the End of Induction	46	—
SECONDARY Overall Survival (OS)	98	—
SECONDARY Recurrence-free Survival (RFS)	28	—
SECONDARY Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug	1; 1; 2	—

Summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving gemcitabine directly into the bladder may kill more tumor cells. PURPOSE: This phase II trial is studying how well gemcitabine works in treating patients with recurrent bladder cancer that has progressed despite previous Bacillus Calmette-Guerin (BCG).

Eligibility Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed superficial transitional cell carcinoma (TCC) of the bladder meeting 1 of the following stage criteria:
Stage T1, grade 2-3
Stage Tis
Stage Ta, grade 3-4 or multifocal (> 2 lesions)
Must have received and failed ≥ 2 courses of intravesical Bacillus Calmette-Guerin (BCG) (one 6-week course, plus one 3-week course, or fewer weeks if BCG was discontinued due to side effects) within the past 3 years
Recurrent disease
Must have had a transurethral resection of the bladder tumor (TURBT) or bladder biopsy within the past 60 days documenting tumor recurrence and tumor stage and grade
TURBT or biopsy must have been performed ≥ 6 weeks after the completion of BCG and/or other immunotherapy treatment (or ≥ 14 days after completion of intravesical chemotherapy treatment)
All visible tumor must have been resected at the time of the last biopsy
No evidence of urethral or renal pelvis TCC by upper tract radiological imaging (e.g., intravenous pyelogram, CT urogram, or retrograde pyelogram) within the past 2 years

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

Zubrod 0-2

Life expectancy

Not specified

Hematopoietic

Not specified

Hepatic

Not specified

Renal

Not specified

Other

Not pregnant or nursing
Fertile patients must use effective contraception
No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer that is in complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy

See Disease Characteristics
Prior intravesical interferon alfa allowed, alone or in combination with Bacillus Calmette-Guerin (BCG)

Chemotherapy

See Disease Characteristics
No more than 1 course of intravesical chemotherapy (e.g., thiotepa, mitomycin, or doxorubicin) within the past year, defined as 6 or more weekly instillations, with or without monthly maintenance instillations
No prior gemcitabine

Endocrine therapy

Not specified

Radiotherapy

No prior pelvic radiotherapy
No concurrent radiotherapy to any other area of the body

Surgery

See Disease Characteristics
Recovered from prior surgery

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00234039). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.