NCT00250822

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

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.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: New Mexico Cancer Research Alliance · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Liver Cancer

Interventions

Type	Name	Description
DRUG	Gemcitabine and Oxaliplatin	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

Timeline

• Start date: 2005-10-01
• Primary completion: 2006-07-01
• Completion: 2006-07-01
• First posted: 2005-11-08
• Last updated: 2011-10-05

Locations

4 sites across 1 country: United States