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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
11
Dose: Gemcitabine 1000 mg/m2 - IV in about 60 minutes on days 1 \& 15. Oxaliplatin 100 mg/m2 - IV over 2hr on days 2 \& 16
Hematology Oncology Associates
Albuquerque, New Mexico, United States
Lovelace Sandia Health Systems Dept of Hematology
Albuquerque, New Mexico, United States
University of New Mexico
Albuquerque, New Mexico, United States
St. Vincent Regional Medical Center
Santa Fe, New Mexico, United States
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.
Time frame: Cycles will be repeated every 4 weeks until disease progression.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.