SB-715992 in Treating Patients With Locally Advanced, Recurrent, or Metastatic Liver Cancer (NCT00095992) | Clinical Trial Compass
CompletedPhase 2
SB-715992 in Treating Patients With Locally Advanced, Recurrent, or Metastatic Liver Cancer
Canada15 participantsStarted 2005-03-08
Plain-language summary
RATIONALE: Drugs used in chemotherapy, such as SB-715992, work in different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase II trial is studying how well SB-715992 works in treating patients with locally advanced, recurrent, or metastatic liver cancer.
Who can participate
Age range
18 Years – 120 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 or cytologically confirmed hepatocellular carcinoma
* Locally advanced, recurrent, or metastatic disease
* Histologically confirmed disease must have archival paraffin-fixed tumor specimen available
* Measurable disease
* At least 1 unidimensionally measurable site of disease ≥ 20 mm by x-ray, physical exam, or non-spiral CT scan OR ≥ 10 mm by spiral CT scan
* Outside of previously irradiated area
* Patients whose sole site of disease is in a previously irradiated field are eligible provided there is evidence of disease progression OR new lesions documented in the irradiated field
* Bone metastases are not considered measurable disease
* Not curable by standard therapies
* No cholangiocarcinoma
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-2
Life expectancy
* At least 12 weeks
Hematopoietic
* Absolute granulocyte count ≥ 1,500/mm\^3
* Platelet count ≥ 80,000/mm\^3
Hepatic
* Bilirubin ≤ 2 times upper limit of normal (ULN)
* AST ≤ 5 times ULN
* Must have hepatic reserve of Child-Turcotte-Pugh class A or better
Renal
* Creatinine clearance ≥ 60 mL/min
Cardiovascular
* No myocardial infarction within the past 6 months
* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia
* No active cardiomyopathy
* No uncontrolled hypertension
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* …
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.