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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
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.Check my eligibility
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.See study design
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 belowSelect...
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of patients who are recurrence-free within the DDR mutated group who undergo the bladder sparing approach
Secondary outcome measures
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 moreTrial 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
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 undergo bladder sparing.
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
~1080
Cisplatin
2013
Completed Phase 3
~1940
Gemcitabine Hydrochloride
2005
Completed Phase 3
~5420
Radical Cystectomy
2006
Completed Phase 2
~140
Find a Location
Who is running the clinical trial?
Alliance for Clinical Trials in OncologyLead Sponsor
512 Previous Clinical Trials
217,355 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,748 Previous Clinical Trials
40,959,130 Total Patients Enrolled
Gopa Iyer, MDStudy ChairMemorial Sloan Kettering Cancer Center
1 Previous Clinical Trials
75 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My surgeon has approved me for major bladder surgery.My bladder tumor is no larger than 5 cm, as confirmed by a bladder examination.I have localized prostate cancer and am on an active surveillance program.I do not have serious heart rhythm problems.I haven't had a heart attack, stroke, or major heart surgery in the last 6 months.I have no cancer history except for certain skin cancers, early-stage cancers I've recovered from, or any cancer I've been free from for 5 years.My cancer has not spread beyond its original location.I have not had radiation therapy to my bladder or prostate.My bladder cancer has been confirmed by a biopsy.I haven't had PD-1/PD-L1 inhibitors or chemotherapy in the last 5 years.I am fully active or can carry out light work.My kidneys are functioning well.I do not have significant hearing loss.I do not have any serious ongoing health or mental health conditions.My bladder cancer has a specific genetic change.I have had a cystoscopy and imaging to stage my cancer.I've finished 4+ cycles of chemotherapy and have my DDR gene results.I do not have significant numbness or tingling in my hands or feet.I do not have HIV, AIDS, or any other active infection.My bladder cancer has spread to the prostate but not into the muscle, confirmed by imaging or examination.My cancer is at a stage where it has grown but not spread to distant parts.I can provide 20 slides of my cancer tissue from before treatment for testing.I had a bladder tumor biopsy within the last 60 days.I haven't had major surgery or radiation therapy in the last 4 weeks.I do not have multiple areas of early-stage cancer; only one area is present.My heart condition does not severely limit my daily activities.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (gemcitabine, cisplatin, bladder sparing)
- Group 2: Arm II (gemcitabine, cisplatin, cystectomy, chemoradiotherapy)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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