Study on Intravenous Vitamin C with Gemcitabine and Carboplatin for Muscle Invasive Bladder Cancer
Sponsor: University of Kansas Medical Center
ClinicalTrials ID:NCT06493370
This clinical trial is exploring a new treatment option for patients with muscle invasive bladder cancer who cannot or choose not to use cisplatin. The study combines intravenous vitamin C with the chemotherapy drugs gemcitabine and carboplatin to see if it can help shrink tumors and improve quality of life.
Patient Parameters
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Program Overview
The purpose of this study is to test if adding intravenous vitamin C (IVC) to the chemotherapy drugs gemcitabine and carboplatin can help reduce the size of tumors and improve the quality of life for patients with muscle invasive bladder cancer (MIBC) who cannot or choose not to use cisplatin. Participants will receive two cycles of this combination treatment before undergoing surgery to remove the bladder.
Description
This study is designed for patients with muscle invasive bladder cancer who are either unable to take cisplatin or have chosen not to. The treatment involves adding intravenous vitamin C (IVC) to the standard chemotherapy drugs gemcitabine and carboplatin. The goal is to see if this combination can better shrink tumors and improve patients' quality of life before they undergo surgery to remove the bladder. Participants will receive two cycles of the combination treatment over a period of time before the surgery.
Eligibility Criteria
Inclusion Criteria
- Must understand the study and be willing to sign a consent form.
- Agree to participate in a related biorepository study.
- Men and women aged 18 years or older.
- Have a performance status score of 0 to 2, indicating full activity or some restriction in strenuous activities.
- Women of childbearing potential must have a negative pregnancy test before starting treatment.
- Diagnosed with muscle invasive bladder cancer and unable or unwilling to use cisplatin.
- Have adequate organ function as shown by specific blood tests.
- Agree to use effective birth control during the study and for a period after treatment ends.
Exclusion Criteria
- Currently participating in another treatment study.
- Planning to use other cancer treatments during this study.
- Have a psychiatric condition or social situation that would make it hard to follow the study requirements.
- Pregnant or breastfeeding women.
- Planning to conceive children during or shortly after the study.
- Have a severe allergy to any part of the study drugs.
- Have a serious infection or uncontrolled illness.
- Have a type of bladder cancer that is not eligible for this study.
- Currently using tobacco products or have a history of certain medical conditions that may interfere with the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Holden Comprehensive Cancer Center - The University of Iowa | 52242 | Iowa City | Iowa |
| The University of Kansas Cancer Center | 66160 | Kansas City | Kansas |
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