OncoMatch/Clinical Trials/NCT05644041
Intravesical Gem/Doce in Patients With NMIBC
Is NCT05644041 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies gemcitabine + docetaxel for urinary bladder cancer.
Treatment: gemcitabine + docetaxel — Intravesical immunotherapy or chemotherapy for non-muscle invasive bladder cancer (NMIBC) is a well-established treatment for preventing or delaying tumor recurrence after tumor resection. For high-risk non-muscle invasive bladder cancer, immunotherapy in the form of intravesical Bacillus Calmette-Guérin (BCG) can be effective as first-line; nevertheless, the response rate to BCG is suboptimal with many patients failing treatment. Following BCG-failure, however, very few effective therapeutic options exist besides life-changing cystectomy. Recent shortages of BCG have pushed the use of alternative intravesical therapies for non-muscle invasive bladder cancer. At the University of Arizona Cancer Center, the use of intravesical Gemcitabine + Docetaxel (Gem/Doce) is considered as standard treatment for patients with non-invasive bladder cancer who are unable to get BCG or are BCG-resistant. The role of Gemcitabine as first-line treatment for NMIBC is poorly understood. The purpose of this study is to gain a better understanding of the use of Gemcitabine + Docetaxel intravesical chemotherapy for non-muscle invasive bladder cancer.
Check if I qualifyExtracted eligibility criteria
Cancer type
Urothelial Carcinoma
Disease stage
Required: Stage TIS
Excluded: Stage T2 OR HIGHER
Grade: intermediatehigh
Histologically confirmed intermediate or high-risk non-muscle invasive urothelial carcinoma of the bladder (Ta, T1, or Tis stage)... Clinical T2 or higher stage UC of the bladder [excluded].
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: transurethral resection of bladder tumor
Post-transurethral bladder tumor resection
Cannot have received: BCG
Exception: Patients with a high-grade recurrence after 24 months since last dose of BCG
no previous BCG treatment
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Arizona Cancer Center · Tucson, Arizona
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