Intravesical Gem/Doce in Patients With NMIBC

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Arizona

About this trial

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.

Eligibility criteria

Qualifiers

Patients able to consent in English or Spanish; provision of signed and dated informed consent form

Stated willingness to comply with all study procedures and availability for the duration of the study

Male or female ages ≥18 years.

Patients with intermediate or high-risk non-muscle-invasive UC of the bladder and no previous BCG treatment.

Disqualifiers

Known hypersensitivity reaction to gemcitabine and/or docetaxel.

Clinical T2 or higher stage UC of the bladder.

Histopathology demonstrating any small cell component, pure adenocarcinoma, pure squamous cell carcinoma, or pure CIS of the bladder.

Active malignancies other than the disease being treated under study.

Trial design

Treatments tested in this trial

  • gemcitabine + docetaxel

Treatment groups

25 Participants
are divided into 1 treatment group

Sponsors and collaborators