Spots Global Cancer Trial Database for Gemcitabine and Oxaliplatin for Hepatocellular Carcinoma With Platelet Counts Greater Than 100,000 Per Microliter

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Trial Identification

Brief Title: Gemcitabine and Oxaliplatin for Hepatocellular Carcinoma With Platelet Counts Greater Than 100,000 Per Microliter

Official Title: 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.

Study ID: NCT00250822

Conditions

Liver Cancer

Interventions

Gemcitabine and Oxaliplatin

Study Description

Brief 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.

Detailed Description: 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.