Study on Gemcitabine and Cisplatin Without Surgery for Patients with Muscle Invasive Bladder Cancer with Specific Genetic Changes
Sponsor: Alliance for Clinical Trials in Oncology
ClinicalTrials ID:NCT03609216
This clinical trial is testing how well the chemotherapy drugs gemcitabine and cisplatin work in treating patients with muscle invasive bladder cancer who have certain genetic changes, without needing surgery to remove the bladder.
Patient Parameters
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Program Overview
The purpose of this study is to see if the chemotherapy drugs gemcitabine and cisplatin can effectively treat muscle invasive bladder cancer in patients with specific genetic changes, without the need for bladder removal surgery. These drugs work by stopping cancer cells from growing, dividing, or spreading.
Description
The main goal of this study is to find out how many patients remain free of cancer for three years after receiving gemcitabine and cisplatin chemotherapy, without needing bladder removal surgery. The study will also look at how well patients respond to the treatment, how long they live without cancer returning, and the overall survival rates.
Participants will receive gemcitabine and cisplatin through an IV, with treatment cycles repeating every 14 days for up to 6 cycles, unless the cancer progresses or side effects become too severe. After treatment, participants will be monitored for five years.
Participants will be divided into two groups based on their genetic changes and cancer stage. One group will avoid bladder removal surgery, while the other group may undergo surgery or additional treatments if needed.
Eligibility Criteria
Inclusion Criteria
- Must have muscle invasive bladder cancer confirmed by lab tests.
- Cancer must be at a specific stage and not have spread to other parts of the body.
- Must be a suitable candidate for bladder removal surgery.
- Must not have multiple areas of cancer in the bladder.
- Must have a single bladder tumor no larger than 5 cm.
- Must not have received certain cancer treatments in the past five years.
- Must not have had radiation therapy to the bladder or prostate.
- Must not have had major surgery or radiation therapy within four weeks of joining the study.
- Must not be pregnant or nursing, and women of childbearing potential must have a negative pregnancy test.
- Must have a good performance status and meet specific blood test criteria.
- Must not have certain heart conditions or other serious medical issues.
- Must not have a history of allergic reactions to similar drugs.
- Must not be participating in another clinical trial.
- Must not have had another cancer, except for certain types that have been treated and are in remission.
- Must have completed at least four cycles of chemotherapy and have genetic test results available.
- Must have specific genetic changes in their cancer cells.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Fairbanks Memorial Hospital | 99701 | Fairbanks | Alaska |
| CTCA at Western Regional Medical Center | 85338 | Goodyear | Arizona |
| Cancer Center at Saint Joseph's | 85004 | Phoenix | Arizona |
| Mercy Hospital Fort Smith | 72903 | Ft. Smith | Arkansas |
| CHI Saint Vincent Cancer Center Hot Springs | 71913 | Hot Springs | Arkansas |
| University of Arkansas for Medical Sciences | 72205 | Little Rock | Arkansas |
| Mission Hope Medical Oncology - Arroyo Grande | 93420 | Arroyo Grande | California |
| Mercy Cancer Center - Carmichael | 95608 | Carmichael | California |
| Mercy San Juan Medical Center | 95608 | Carmichael | California |
| Mercy Cancer Center - Elk Grove | 95758 | Elk Grove | California |
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