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New treatment option for Bladder Cancer
Official title Intravesical GEM/DOCE for HR BCG-Unresponsive NMIBC
ClinicalTrials.gov ID: NCT07322263
What this study is testing
What is Intravesical Gemcitabine and Docetaxel?
Intravesical Gemcitabine and Docetaxel is an investigational medicine, given as an once-weekly, being studied as a potential treatment for bladder cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to learn whether a combination of two chemotherapy drugs, Gemcitabine and Docetaxel, can treat high-grade non-muscle-invasive bladder cancer (HG-NMIBC) in adults whose cancer failed conventional BCG therapy. The drugs are given directly into the bladder (intravesically), one immediately after the other.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 5 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 99
You may be able to join if
- Histologically confirmed diagnosis of urothelial carcinoma of the bladder without synchronous or metachronous upper tract involvement or prostatic...
- Carcinoma in situ (CIS), with or without non-muscle-invasive stage Ta or T1 tumors of any grade.
- High-Grade Papillary tumors (stages Ta and/or T1) without CIS.
- All visible bladder tumors must be completely resected within 8 weeks prior to initiating intravesical Gem/Doce therapy.
- If more than 8 weeks have passed since diagnosis or resection of index bladder CIS ± non-invasive tumor (pTa or T1 tumors), an office cystoscopy must...
You likely can't join if
- History or concurrent Stage T2 or greater urothelial cancer.
- History or concurrent upper tract or prostatic urethral cancer (no suspicious or positive upper tract cytology and negative upper tract imaging...
- History or concurrent variant bladder cancer histology including squamous cell carcinoma, adenocarcinoma, small cell carcinoma, plasmacytoid...
- Active other malignancies excluding indolent or well-controlled prostate cancer, basal or squamous cell skin cancers or non-invasive cancer of the...
- History of severe hypersensitivity reaction (\>= grade 3) to Gemcitabine and/or Docetaxel.
- History of severe hypersensitivity reaction (\>= grade 3) to Polysorbate 80 containing drugs (Docetaxel is formulated with Polysorbate 80)
See the full eligibility criteria
Who can join
- Histologically confirmed diagnosis of urothelial carcinoma of the bladder without synchronous or metachronous upper tract involvement or prostatic urethral involvement. people with negative upper tract imaging within 6...
- Carcinoma in situ (CIS), with or without non-muscle-invasive stage Ta or T1 tumors of any grade.
- High-Grade Papillary tumors (stages Ta and/or T1) without CIS.
- All visible bladder tumors must be completely resected within 8 weeks prior to initiating intravesical Gem/Doce therapy.
- If more than 8 weeks have passed since diagnosis or resection of index bladder CIS ± non-invasive tumor (pTa or T1 tumors), an office cystoscopy must be performed within 8 weeks of Gem/Doce initiation to confirm no...
- Occurrence of high-grade, stage T1 cancer after at least 5/6 weekly BCG induction treatments.
- Occurrence of CIS within 12 months, or high-grade papillary disease, stage Ta/T1, within 6 months after an "adequate" course of BCG therapy. An "adequate" course of BCG includes at least 5/6 weekly BCG induction...
- N.B: Physician may have some flexibility (+/- 1 month) in the use of 6 and 12 months to define BCG-unresponsive NMIBC.
- N.B: Once a patient has been correctly defined as having BCG-unresponsive disease, they will be considered to always be BCG-unresponsive for the purpose of this study. In other words, there is no restriction as to when...
- The occurrence of low-grade (LG) Ta disease will not be considered a HG relapse event given its prognosis is much more favorable that HG disease. However, all LG tumor must be completely resected before continuing with...
- people must be eligible for radical cystectomy and decline this standard of care treatment or not be a surgical candidate for radical cystectomy (as appropriate) based on other comorbidities.
- All grossly visible disease in the bladder must be fully resected with pathologic stage and grade assessed at the local study institution. Local pathologists are strongly encouraged to use the current LG and HG AJCC...
- Patients enrolled in other clinical trials must have received their last treatment at least 8 weeks prior to enrollment if the treatment was an intravesical agent. If the treatment included a systemic immune-modulating...
- Age \> 18 and must be able to read, understand and sign the local informed consent.
- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance Status of 2 or less, including patients who are not surgical candidates due to comorbid conditions.
- Women of childbearing potential must have a negative pregnancy test at screening.
- All patients of childbearing potential must be willing to consent to using effective contraception, i.e., IUD, Birth control pills, Depo-Provera, and/or condoms while on treatment and for 3 months after their last...
- No intravesical or upper tract topical therapy within 8 weeks of study entry.
- Must be willing and able to comply with all protocol requirements.
- Should have a Complete Blood Count (CBC) with differential before the index tumor resection or biopsy (within 30 days) and/or within 14 days before starting Gemcitabine/Docetaxel therapy.
- Must be willing and able to give informed consent and any authorizations required by the local Institutional Review Board (IRB) for participation in this study.
What rules you out
- History or concurrent Stage T2 or greater urothelial cancer.
- History or concurrent upper tract or prostatic urethral cancer (no suspicious or positive upper tract cytology and negative upper tract imaging within 6 months of study entry; visually normal or absent prostatic urethra...
- History or concurrent variant bladder cancer histology including squamous cell carcinoma, adenocarcinoma, small cell carcinoma, plasmacytoid carcinoma, nested urothelial carcinoma, sarcomatoid carcinoma, squamous...
- Active other malignancies excluding indolent or well-controlled prostate cancer, basal or squamous cell skin cancers or non-invasive cancer of the cervix are permitted so long as they are not expected to impact 3-year...
- History of severe hypersensitivity reaction (\>= grade 3) to Gemcitabine and/or Docetaxel.
- History of severe hypersensitivity reaction (\>= grade 3) to Polysorbate 80 containing drugs (Docetaxel is formulated with Polysorbate 80)
- Concurrent treatment with any intravesical or systemic chemotherapeutic agent (8-week washout required).
- Treatment with a checkpoint inhibitor within 2 treatment cycles of enrollment.
- Major surgery within 3 months of enrollment.
- Inadequate organ and bone marrow function as evidenced by:
- Hemoglobin ≤8.0 g/dL.
- Absolute neutrophil count ≤1.5 x 109/L.
- Platelet count ≤80 x 109/L.
- AST/SGOT and/or ALT/SGPT ≥3.0 x ULN.
- Total bilirubin \>1.5 x ULN excepting known benign Gilbert's Disease.
- Serum creatinine \>2.0 x ULN. i. If creatinine 1.5 - 2.0 x ULN, creatinine clearance will be calculated according to CKD-EPI formula and patients with creatinine clearance \<30 mL/min should be excluded.
- History of radiation to the pelvis.
- History of difficult catheterization that in the opinion of the Investigator will prevent safe and/or reliable administration of the intravesical agents.
- History of interstitial cystitis or current inability to hold \~ 2 ounces of fluid in the bladder for the expected 60-minute retention time (assistive medication and/or techniques (gravity reflux; split dosing) are...
- Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy (3- week documented clearance required).
- Known human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C infection.
- Recent Covid infection within 30 days of enrollment or currently symptomatic of Covid-related illnesses.
- Significant cardiovascular risk (e.g., coronary stenting within 8 weeks, myocardial infarction within 6 months).
- Women who are pregnant or lactating.
- Participation in any other research protocol involving administration of an investigational agent within 6 weeks of study entry (8-week washout required)
- Any other major or unstable medical condition that in the Investigator's opinion, could affect patient performance status, ability to receive the intravesical therapy and/or life expectancy during the five years of...
The study team makes the final eligibility decision.
Where it's taking place
- Iowa City, Iowa, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 5 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Iowa City, Iowa, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.