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Alkylating agents

Gemcitabine + Cisplatin for Bladder Cancer

Phase 2

Recruiting

Research Sponsored by Alliance for Clinical Trials in Oncology

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

A single muscle-invasive bladder tumor measuring ≤5 cm in size as defined by the surgeons at cystoscopic evaluation

No ongoing cardiac dysrhythmias of NCI CTCAE version 5.0 grade >= 2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial studies gemcitabine hydrochloride and cisplatin as a treatment for bladder cancer.

Who is the study for?

This trial is for adults with muscle-invasive bladder urothelial cancer who are suitable for radical cystectomy, have not had systemic chemotherapy in the past 5 years, and no prior anti-PD-1 or anti PD-L1 therapies. They should not be pregnant or nursing, must have good organ function and performance status (able to carry out daily activities), and cannot have a history of certain heart conditions or other serious illnesses.

What is being tested?

The trial tests how well gemcitabine hydrochloride and cisplatin treat invasive bladder urothelial cancer without surgery. It's a phase II study where these chemotherapy drugs aim to stop tumor growth by killing cells or preventing them from dividing/spreading.

What are the potential side effects?

Possible side effects include nausea, vomiting, hair loss, low blood cell counts leading to increased infection risk and bleeding problems, kidney damage, nerve damage that can cause numbness or pain in hands/feet (neuropathy), hearing loss, and allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My bladder tumor is no larger than 5 cm, as confirmed by a bladder examination.

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I do not have serious heart rhythm problems.

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I haven't had a heart attack, stroke, or major heart surgery in the last 6 months.

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My cancer has not spread beyond its original location.

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I have not had radiation therapy to my bladder or prostate.

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My bladder cancer has been confirmed by a biopsy.

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I haven't had PD-1/PD-L1 inhibitors or chemotherapy in the last 5 years.

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I am fully active or can carry out light work.

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My kidneys are functioning well.

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I do not have significant hearing loss.

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I do not have any serious ongoing health or mental health conditions.

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My bladder cancer has a specific genetic change.

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I've finished 4+ cycles of chemotherapy and have my DDR gene results.

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I do not have significant numbness or tingling in my hands or feet.

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I do not have HIV, AIDS, or any other active infection.

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My cancer is at a stage where it has grown but not spread to distant parts.

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I can provide 20 slides of my cancer tissue from before treatment for testing.

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I do not have multiple areas of early-stage cancer; only one area is present.

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My heart condition does not severely limit my daily activities.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of patients who are recurrence-free within the DDR mutated group who undergo the bladder sparing approach

Secondary study objectives

Bladder-intact survival in DDR-altered patients with < cT1 responses who selected the bladder sparing approach

Clinical response rate for patients harboring deleterious DDR gene alterations

Overall survival

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm II (gemcitabine, cisplatin, cystectomy, chemoradiotherapy)Experimental Treatment5 Interventions

Participants receive gemcitabine hydrochloride IV over 30 minutes on day 1, cisplatin IV on days 1 and 2, and pegfilgrastim SC on day 3. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unaccepted toxicity. Participants with DDR gene alteration and disease stage \>= cT1 or participants without DDR gene alteration undergo radical cystectomy or chemoradiotherapy.

Group II: Arm I (gemcitabine, cisplatin, bladder sparing)Experimental Treatment4 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pegfilgrastim

2013

Completed Phase 3

~4440

Conventional Surgery

2006

Completed Phase 3