Gemcitabine, Oxaliplatin, Tarceva &/or Cisplatin in HCC & Biliary Tree Cancers (NCT00832637) | Clinical Trial Compass
TerminatedPhase 2
Gemcitabine, Oxaliplatin, Tarceva &/or Cisplatin in HCC & Biliary Tree Cancers
Stopped: Low accrual
United States33 participantsStarted 2007-08
Plain-language summary
This is a single arm phase II trial of Gemcitabine and Oxaliplatin (Gem-Ox) with Erlotinib (Tarceva) for the treatment of hepatocellular carcinoma (HCC) and biliary tree cancer (BTC) patients with platelet counts 100,000/µL. The purpose of this study is to determine the tumor control rate following treatment with GEM-OX combined with Tarceva in patients with HCC. Tumor control rate is defined as the percentage of patients achieving a complete response, partial response, or stable disease at 24 weeks following treatment.
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:
* Histologically or cytologically confirmed hepatocellular carcinoma (HCC) or biliary tree cancer (BTC:: intra- and extra-hepatic cholanciocarcinoma, bile duct cancer, adenocarcinoma of the Ampulla of Vater and/or gallbladder carcinoma).
* Patients must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST).
* Age 18 years or older.
* Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-2
* Adequate bone marrow as evidenced by:
* Absolute neutrophil count (ANC) \> 1,500/L.
* Platelet count \> 100,000/L.
* Absence of a regular red blood cell transfusion requirement.
* Adequate renal function as evidenced by serum creatinine \< 1.5 mg/dL.
* Adequate hepatic function as evidenced by:
* Serum total bilirubin 1.5x Upper Limit of Normal (ULN).
* Alkaline phosphatase \< 3x ULN for the reference lab (\< 5x ULN for patients with known hepatic metastases).
* Serum glutamic-oxaloacetic transaminase (SGOT)/ serum glutamic-pyruvic transaminase (SGPT) \< 3x ULN for the reference lab (\< 5x ULN for patients with known hepatic metastases).
* Patients must have a life expectancy of 12 weeks.
* Patients must be recovered from both acute and late effects of any prior surgery, radiotherapy or other antineoplastic therapy.
* Patients of childbearing potential agree to use an effective form of contraception during the study and for 90 days following the last dose of study medication (an effective form of contracepti…
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.