RECRUITING

Intravesical Gem/Doce in Patients With NMIBC

Conditions

Urinary Bladder Cancer Bacillus Calmette-Guérin (BCG)Nonmuscle invasive bladder cancer (NMIBC)Intravesical immunotherapy Post-transurethral resection

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Phase II Trial of Intravesical Gemcitabine + Docetaxel in Patients With Nonmuscle Invasive Bladder Cancer With or Without Prior Bacillus Calmette-Guérin Therapy

Quick Facts

Study Start:2023-03-01

Study Completion:2026-01-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05644041

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Patients able to consent in English or Spanish; provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Male or female ages ≥18 years. 4. Patients with intermediate or high-risk non-muscle-invasive UC of the bladder and no previous BCG treatment. 1. Histologically confirmed intermediate or high-risk non-muscle invasive urothelial carcinoma of the bladder (Ta, T1, or Tis stage) on Transurethral Resection of Bladder Tumor (TURBT) must be obtained within 180 days of registration. OR Patients with a high-grade recurrence after 24 months since last dose of BCG. 6. Eastern Cooperative Oncology Group (ECOG) performance status Grade 0-2. 7. Post-transurethral bladder tumor resection. 8. Evidence of post-menopausal status or negative urinary pregnancy test of female pre-menopausal patients is required. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause.	1. Known hypersensitivity reaction to gemcitabine and/or docetaxel. 2. Clinical T2 or higher stage UC of the bladder. 3. Histopathology demonstrating any small cell component, pure adenocarcinoma, pure squamous cell carcinoma, or pure CIS of the bladder. 4. Active malignancies other than the disease being treated under study. 5. Subjects with concurrent upper urinary tract (i.e. ureter, renal pelvis) urothelial carcinoma of any stage. 6. Pregnant or breast-feeding women. 7. Has an underlying substance abuse or psychiatric disorder such that, in the opinion of the investigator, the patient would be unable to comply with the protocol.

Inclusion Criteria

Exclusion Criteria

1. Patients able to consent in English or Spanish; provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female ages ≥18 years.
4. Patients with intermediate or high-risk non-muscle-invasive UC of the bladder and no previous BCG treatment.
1. Histologically confirmed intermediate or high-risk non-muscle invasive urothelial carcinoma of the bladder (Ta, T1, or Tis stage) on Transurethral Resection of Bladder Tumor (TURBT) must be obtained within 180 days of registration. OR Patients with a high-grade recurrence after 24 months since last dose of BCG.
6. Eastern Cooperative Oncology Group (ECOG) performance status Grade 0-2. 7. Post-transurethral bladder tumor resection. 8. Evidence of post-menopausal status or negative urinary pregnancy test of female pre-menopausal patients is required. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause.

1. Known hypersensitivity reaction to gemcitabine and/or docetaxel.
2. Clinical T2 or higher stage UC of the bladder.
3. Histopathology demonstrating any small cell component, pure adenocarcinoma, pure squamous cell carcinoma, or pure CIS of the bladder.
4. Active malignancies other than the disease being treated under study.
5. Subjects with concurrent upper urinary tract (i.e. ureter, renal pelvis) urothelial carcinoma of any stage.
6. Pregnant or breast-feeding women.
7. Has an underlying substance abuse or psychiatric disorder such that, in the opinion of the investigator, the patient would be unable to comply with the protocol.

Contacts and Locations

Study Contact

Juan Chipollini, MD

CONTACT

(520) 626-6895

jchipollini@urology.arizona.edu

Michele Chu-Pilli

CONTACT

(520) 626-1183

chum@arizona.edu

Principal Investigator

Juan Chipollini, MD

PRINCIPAL_INVESTIGATOR

University of Arizona

Study Locations (Sites)

University of Arizona Cancer Center

Tucson, Arizona, 85721

United States

Collaborators and Investigators

Sponsor: University of Arizona

Juan Chipollini, MD, PRINCIPAL_INVESTIGATOR, University of Arizona

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-01

Study Completion Date2026-01-31

Study Record Updates

Study Start Date2023-03-01

Study Completion Date2026-01-31

Terms related to this study

Keywords Provided by Researchers

Bacillus Calmette-Guérin (BCG)
Nonmuscle invasive bladder cancer (NMIBC)
Intravesical immunotherapy
Post-transurethral resection

Additional Relevant MeSH Terms

Urinary Bladder Cancer