CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 58 enrolled
Drug / intervention
gemcitabine hydrochloridedrug
Likely dose
Not stated in record
Key inclusion· 7
  • ✓Histologically confirmed superficial transitional cell carcinoma (TCC) of the bladder: Stage T1 grade 2-3, Stage Tis, or Stage Ta grade 3-4 or multifocal (>2 lesions)
  • ✓Must have received and failed at least 2 courses of intravesical BCG (one 6-week course plus one 3-week course, or shorter if discontinued due to side effects) within past 3 years
  • ✓Recurrent disease documented by TURBT or bladder biopsy within past 60 days confirming tumor recurrence with stage and grade assessment
  • ✓TURBT or biopsy performed ≥6 weeks after completion of BCG and/or other immunotherapy (or ≥14 days after intravesical chemotherapy)
Key exclusion· 6
  • ✕Evidence of urethral or renal pelvis TCC by upper tract imaging (IVP, CT urogram, or retrograde pyelogram) within past 2 years
  • ✕Prior gemcitabine therapy
  • ✕More than 1 course of intravesical chemotherapy (thiotepa, mitomycin, doxorubicin) within past year, defined as ≥6 weekly instillations
  • ✕Prior pelvic radiotherapy

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00234039
NCT00234039Phase 2Completed
CompareCT.gov

Phase II Study of Intravesical Gemcitabine in Patients With Superficial Bladder Cancer Who Have Progressed Despite Intravesical BCG

SWOG Cancer Research Network·interventional·Posted Oct 6, 2005·Updated Jan 8, 2016

In Brief

A Phase 2 clinical trial evaluating gemcitabine hydrochloride for Bladder Cancer. Completed, enrolled 58 participants across 98 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBladder Cancer
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 6, 2005
Enrollment StartNov 1, 2006
Primary CompletionNov 1, 2011
Study CompletionApr 1, 2013
TodayJul 2, 2026
Enrollment to primary: 5 yearsPosted 20.7 years ago

Interventions

gemcitabine hydrochloridedrug