Clinical trial · Interventional
S0353, Gemcitabine in Treating Patients With Recurrent Bladder Cancer That Has Not Responded to Previous Bacillus Calmette-Guerin
Phase II Study of Intravesical Gemcitabine in Patients With Superficial Bladder Cancer Who Have Progressed Despite Intravesical BCG
NCT00234039CI-TRIAL-00020467completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intravesical Gemcitabine
- interventionNames
- Drug: gemcitabine hydrochloride
Primary outcomes (1)
- measure
- Complete Response Rate at the End of Induction
- timeFrame
- Week 8-12, then every 3 months for the first 2 years, and then every 6 months for the years 3-5
- description
- Complete Response is defined as negative cystoscopy with negative biopsy and no evidence of cancer on urine cytology at the Week 8 - 12 cystoscopy
Secondary outcomes (3)
- measure
- Overall Survival (OS)
- timeFrame
- 1 year
- description
- Measured from the day of registration to death due to any cause. Survival is censored at date of last contact.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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 surgeryReferences
Publications (0)
Data not yet available
No reference posted for this study.