Single Arm, Non Randomized Phase II Trial of Gemcitabine and Oxaliplatin (GEM-OX) for Hepatocellular Carcinoma (HCC) Patients With Platelet Counts Greater Than 100,000 Per Microliter.
The treatment plan is a two-step design. Day 1 the pt will receive Gemcitabine IV and Day 2
the pt will receive Oxaliplatin IV. This treatment cycle is repeated approximately every 28
days. Subsequent treatment cycle dosages are based on toxicity diaries and lab work
results. CT scans are repeated every 2 treatment cycles. Continuation in the study is
dependent upon tumor response.
Interventional
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
Cycles will be repeated every 4 weeks until disease progression.
Yes
Yehuda Patt, MD
Principal Investigator
University of New Mexico
United States: Institutional Review Board
INST 0521C
NCT00250822
October 2005
July 2006
Name | Location |
---|---|
University of New Mexico | Albuquerque, New Mexico 87131 |
Hematology Oncology Associates | Albuquerque, New Mexico 87106 |
Lovelace Sandia Health Systems Dept of Hematology | Albuquerque, New Mexico 87108 |
St. Vincent Regional Medical Center | Santa Fe, New Mexico 87505 |