Gemcitabine and Oxaliplatin for Hepatocellular Carcinoma With Platelet Counts Greater Than 100,00… (NCT00250822) | Clinical Trial Compass
CompletedPhase 2
Gemcitabine and Oxaliplatin for Hepatocellular Carcinoma With Platelet Counts Greater Than 100,000 Per Microliter
United States11 participantsStarted 2005-10
Plain-language summary
To determine the primary end point response rate of the combinations of Gemcitabine and Oxaliplatin (Gem-Ox) in the treatment of hepatocellular carcinoma (HCC) in patients with platelet counts greater 100,000 per microliter in a single arme Phase II trial.
To determine the toxicity profile of this regimen To determine the effect of this treatment on patient survival, time to treatment failure, time ot progression, time to response.
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.
Inclusion Criteria:
* All patients 18 years of age or older, with hepatocellular carcinoma are eligible.
* Patients must have a life expectancy of at least 12 weeks.
* Patients must have a ECOG performance status of 0-2.
* Patients must sign an informed consent.
* Patients should have adequate bone marrow function defined by an absolute peripheral granulocyte count of \> 1,500 or cells/mm3 and platelet count \>100,000/mm3 and absence of a regular red blood cell transfusion requirement.
* Patients should have adequate hepatic function with a total bilirubin \< 2 mg/dl and SGOT or SGPT \< two times the upper limit of normal, and adequate renal function as defined by a serum creatinine \< 1.5 x upper limit of normal.
* There must be one measurable lesion according to the RECIST criteria that should not have had prior radiation treatment.
Exclusion Criteria:
* Patients with symptomatic brain metastases that had not been adequately and definitively treated with radiation and/or surgical resection are excluded from this study.
* Pregnant women or nursing mothers are not eligible for this trial. Patients of child bearing potential must use adequate contraception.
* Patients may receive no other concurrent chemotherapy or radiation therapy during this trial.
* Patients with severe medical problems such as uncontrolled diabetes mellitus or cardiovascular disease or active infections are not eligible for this trial.
* Life expectancy of less than 12 weeks.
* Serious, uncontrolled co…
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.
What they're measuring
1
Response Rate ( CR + PR rate); namely, to determine response rate to the Gemcitabine and Oxaliplatin combination administered to patients with hepatocellular cancer. Furthermore, patients who achieve a response leading to tumor respectability.
Timeframe: Cycles will be repeated every 4 weeks until disease progression.