Intravesical Gemcitabine and Docetaxel for BCG naïve Non-muscle Invasive Bladder Cancer

NCT04386746 | Active Not Recruiting Phase 2 Results FDA Drug

• 2 other identifiers: J2020IRB00241941
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

A single-arm, two-stage, open-label, phase 2 study investigating the safety and efficacy of intravesical gemcitabine/docetaxel for bacillus Calmette-Guerin (BCG)-naïve patients with non-muscle invasive bladder cancer (NMIBC).

Conditions

Urothelial Carcinoma Bladder; Bladder Cancer

Keywords

NMIBC

Outcome Measures

Primary Outcomes (1)

• 3-Month Complete Response Rate

  Number of patients with no evidence of recurrent high grade urothelial carcinoma of the bladder of any stage as assessed by cystoscopy with biopsy and urine cytology.

  3 months

Secondary Outcomes (24)

• 12-Month Relapse-Free Survival Rate

  12 months

• 24-Month Relapse-Free Survival Rate

  24 months

• Safety Profile as Assessed by Proportion of Adverse Events by Type

  Up to 24 months

• Safety Profile as Assessed by Proportion of Adverse Events by Grade

  Up to 24 months

• Number of Gene Alterations as Measured by RNA-seq

  3 months

Study Arms (1)

Intravesical Gemcitabine/Docetaxel

EXPERIMENTAL

Gemcitabine/Docetaxel induction is given intravesically in sequential order once a week for six consecutive weeks. One gram of gemcitabine in 50 ml of sterile water is slowly instilled into the bladder via a Foley catheter and the catheter is clamped for 60 minutes. The bladder is then drained and 40 mg of docetaxel in 50 ml of NSS is then slowly instilled via the Foley catheter into the bladder. The catheter is again clamped for 60 minutes before draining. If initial efficacy seen, patients will have monthly maintenance instillations of Gemcitabine/Docetaxel.

Drug: Gemcitabine; Drug: Docetaxel

Interventions

Gemcitabine DRUG

1g gemcitabine in 50ml sterile water; instilled once weekly for 6 weeks and then once monthly for ≤ 21 months.

Also known as: Gemzar

Intravesical Gemcitabine/Docetaxel

Docetaxel DRUG

37.5mg docetaxel in 50ml normal saline solution (NSS); instilled once weekly for 6 weeks and then once monthly for ≤ 21 months.

Also known as: Taxotere

Intravesical Gemcitabine/Docetaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed intermediate or high-risk non-muscle invasive urothelial carcinoma of the bladder (Ta, T1, or Tis stage) on TURBT obtained within 90 days of registration defined according to modified EORTC risk criteria summarized as follows:
• Low-risk tumors: Initial or recurrent tumor \> 12 months after resection with all of the following:
• Solitary tumor
• Low-grade
• \< 3 cm
• No carcinoma in situ (CIS)
• Intermediate-risk tumors: All tumors not defined in the two adjacent categories (between the category of low- and high-risk)
• High-risk tumors: Any of the following:
• T1 tumor
• High-grade
• CIS
• Multiple and recurrent and large (\> 3 cm) Ta low-grade tumors (all conditions must be met for this point of Ta low-grade tumors)
• Note #1: Low-risk tumors as defined above are not eligible
• Note #2: Mixed histologies are permitted, provided a component of urothelial carcinoma is present
• Note #3: All patients with high-grade T1 (HGT1) should undergo a restaging TURBT

You may not qualify if:

• Subjects with muscle-invasive (i.e. T2, T3, T4), locally advanced unresectable, or metastatic urothelial carcinoma as assessed on baseline radiographic imaging obtained within 90 days prior to study registration. The required radiographic imaging includes:
• Abdomen/Pelvis - CT scan
• Chest - chest x-ray or CT scan
• Subjects with concurrent upper urinary tract (i.e. ureter, renal pelvis) urothelial carcinoma of any stage.
• a. Note: Subjects with history of non-invasive (Ta, Tis) upper tract urothelial carcinoma that has been definitively treated with at least one post-treatment disease assessment (i.e. cytology, biopsy, imaging) that demonstrates no evidence of residual disease are eligible.
• Subjects with another active second malignancy with an estimated overall survival from the second malignancy of \< 12 months. Subjects with another second active malignancy that are deemed to have an estimated overall survival of \>12 months are eligible.
• Subjects who have received the last administration of an anti-cancer therapy including chemotherapy, immunotherapy, and monoclonal antibodies ≤ 4 weeks prior to starting study drug, or who have not recovered from the side effects of such therapy.
• Subjects who have had radiotherapy ≤ 4 weeks prior to starting study drug, or who have not recovered from radiotherapy toxicities.
• Pregnant or breast-feeding women.
• Subjects unwilling or unable to comply with the protocol.
• Patients with prior systemic gemcitabine or docetaxel use for a non-bladder malignancy may enroll and receive treatment.

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead

Study Sites (1)

Johns Hopkins University: Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, 21287, United States

Location

Related Links

• Sidney Kimmel Comprehensive Cancer Center website

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Non-Muscle Invasive Bladder Neoplasms

Interventions

Gemcitabine; Docetaxel

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Results Point of Contact

• Title: Max Kates, MD
• Organization: Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

mkates@jhmi.edu

4105028130

Study Officials

• Max Kates, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2020
• First Posted: May 13, 2020
• Study Start: July 29, 2020
• Primary Completion: October 4, 2022
• Study Completion (Estimated): November 30, 2026
• Last Updated: November 17, 2025
• Results First Posted: September 13, 2023

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)