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 range18 Years
SexALL
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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…