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Sponsored by: |
University of New Mexico |
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Information provided by: | University of New Mexico |
ClinicalTrials.gov Identifier: | NCT00250822 |
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.
Condition | Intervention | Phase |
---|---|---|
Liver Cancer |
Drug: Gemcitabine and Oxaliplatin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment |
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. |
Estimated Enrollment: | 43 |
Study Start Date: | October 2005 |
Estimated Study Completion Date: | October 2010 |
Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
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
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, New Mexico | |
University of New Mexico | |
Albuquerque, New Mexico, United States, 87131 | |
Hematology Oncology Associates | |
Albuquerque, New Mexico, United States, 87102-3661 | |
Lovelace Sandia Health Systems Dept of Hematology | |
Albuquerque, New Mexico, United States, 87108 | |
St. Vincent Regional Medical Center | |
Santa Fe, New Mexico, United States, 87505 |
Principal Investigator: | Yehuda Patt, MD | University of New Mexico |
Responsible Party: | University of New Mexico - CRTC ( Yehuda Patt, MD; Principal Investigator ) |
Study ID Numbers: | INST 0521C |
Study First Received: | November 4, 2005 |
Last Updated: | July 24, 2009 |
ClinicalTrials.gov Identifier: | NCT00250822 History of Changes |
Health Authority: | United States: Institutional Review Board |
Liver hepatocellular Gem-Ox Cancer |
Antimetabolites Anti-Infective Agents Liver Diseases Digestive System Neoplasms Immunologic Factors Carcinoma, Hepatocellular Immunosuppressive Agents Antiviral Agents Carcinoma |
Liver Neoplasms Oxaliplatin Digestive System Diseases Radiation-Sensitizing Agents Gastrointestinal Neoplasms Adenocarcinoma Hepatocellular Carcinoma Gemcitabine Neoplasms, Glandular and Epithelial |
Antimetabolites Anti-Infective Agents Liver Diseases Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Carcinoma, Hepatocellular Antineoplastic Agents Physiological Effects of Drugs Liver Neoplasms Oxaliplatin Neoplasms by Site Therapeutic Uses |
Gemcitabine Digestive System Neoplasms Neoplasms by Histologic Type Enzyme Inhibitors Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Carcinoma Neoplasms Digestive System Diseases Radiation-Sensitizing Agents Adenocarcinoma Neoplasms, Glandular and Epithelial |