Tributyrin in Treating Patients With Refractory Prostate Cancer or Other Solid Tumors (NCT00002677) | Clinical Trial Compass
CompletedPhase 1
Tributyrin in Treating Patients With Refractory Prostate Cancer or Other Solid Tumors
United States24 participantsStarted 1995-08
Plain-language summary
Phase I trial to study the effectiveness of tributyrin in treating patients with refractory stage IV prostate cancer or other solid tumors. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
DISEASE CHARACTERISTICS:
* Histologically proven prostate cancer or other solid tumor that is refractory to standard treatment or for which no standard therapy exists
* Patients with prostate cancer must meet the following conditions:
* Stage D2 disease
* Disease progression after orchiectomy or treatment with leuprolide or flutamide
* If no prior orchiectomy, must continue leuprolide or other antiandrogen throughout study
* No CNS neoplasms or brain metastases
PATIENT CHARACTERISTICS:
* Age: 18 and over
* Performance status: ECOG 0-2
* Life expectancy: More than 3 months
* WBC at least 3,000/mm3
* Platelet count at least 100,000/mm3
* Hemoglobin at least 9 g/dL
* Bilirubin no greater than 1.5 mg/dL
* AST and ALT no greater than 1.5 times normal
* Creatinine no greater than 1.5 mg/dL OR creatinine clearance greater than 50 mL/min
* No concurrent medical or psychiatric condition that would preclude study
* Able to swallow numerous capsules
* Willing to participate in pharmacokinetic studies
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
* At least 4 weeks since prior chemotherapy (more than 8 weeks since prior carmustine, mitomycin, or other drugs with delayed toxic effects) and recovered
* No prior suramin
* At least 4 weeks since prior flutamide
* No concurrent hydrocortisone or other steroids
* At least 4 weeks since prior radiotherapy and recovered
* No concurrent palliative radi…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.