Gemcitabine, Oxaliplatin in Combination With Bevacizumab in Patients With Hepatocellular Carcinoma
This study has been completed.
Sponsor:
Massachusetts General Hospital
Collaborators:
Dana-Farber Cancer Institute
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Genentech
Sanofi-Synthelabo
Eli Lilly and Company
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00142467
First received: August 31, 2005
Last updated: August 7, 2009
Last verified: August 2009
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Purpose
The purpose of this study is to test the safety of bevacizumab when given in combination with gemcitabine and oxaliplatin and to see what effects (good or bad) it has on patients with hepatocellular carcinoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatocellular Carcinoma |
Drug: Gemcitabine Drug: Oxaliplatin Drug: Bevacizumab |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study of Gemcitabine, Oxaliplatin in Combination With Bevacizumab (Avastin) in Patients With Hepatocellular Carcinoma |
Resource links provided by NLM:
Further study details as provided by Massachusetts General Hospital:
Primary Outcome Measures:
- To assess the time to disease progression of gemcitabine, oxaliplatin and bevacizumab regimen in patients with hepatocellular carcinoma.
Secondary Outcome Measures:
- To evaluate the side effects of this drug combination in this population of patients as well as the response rate, duration of response and median survival.
| Estimated Enrollment: | 30 |
| Study Start Date: | April 2004 |
- Treatment is given in cycles, each cycle (except for cycle 1) is 4 weeks long. Cycle 1 is only 2 weeks long.
- During cycle one only, bevacizumab will be given intravenously on day one. Two weeks after receiving bevacizumab, the patient will return to the clinic for treatment with all 3 study drugs.
- During cycle 2 and every cycle thereafter patients will receive; bevacizumab intravenously on day one and day 15; gemcitabine intravenously on day 2 and day 16; oxaliplatin intravenously on day 2 and day 16.
- The following evaluations will be conducted on day 1 and day 15 of each cycle (once every 2 weeks): physical examination, vital signs, medical history, blood tests and urine tests.
- Tumor measurements done by CT and/or MRI will be repeated at the end of cycle 3 and every 2 cycles thereafter.
- Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI) of the liver and Perfusions CT scans will also be done on days 10-12 following bevacizumab treatment during cycle 1, and the Perfusion CT will be repeated at the end of cycle 3.
- Once study treatment is stopped the following evaluations will be performed: physical exam, vital signs, blood work, urine tests, CT scan of chest, abdomen and pelvis, and tumor measurements by CT or MRI scans.
- Follow-up will consist of physical examinations and blood tests every 6 months.
- Patients will continue to receive study treatment as long as there is no disease progression or unacceptable side affects.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Unresectable or metastatic hepatocellular carcinoma
- Measurable tumors
- Adequate hepatic function: total bilirubin < 3.0mg/dl; AST < 7x ULN
- Adequate bone marrow function: ANC > 1,000/mm3; platelets > 75,000/mm3
- INR < 1.5 for those who are not on anticoagulation
- Up to two prior chemotherapy regimens for hepatocellular carcinoma
- 18 years of age or older
- ECOG performance status of 0-1
- Life expectancy of > 12 weeks
Exclusion Criteria:
- Clinically apparent central nervous system metastases or carcinomatous meningitis
- Uncontrolled serious medical or psychiatric illness
- Pregnant or lactating women
- Current or recent (within 4 weeks of first study infusion) participation in experimental study drug
- Uncontrolled hypertension
- Significant proteinuria
- Serious, non-healing wound, ulcer, or bone fracture
- Evidence of bleeding diathesis or coagulopathy
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00142467
Locations
| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| Dana-Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| Beth Israel Deaconess Medical Center | |
| Boston, Massachusetts, United States, 02115 | |
Sponsors and Collaborators
Massachusetts General Hospital
Dana-Farber Cancer Institute
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Genentech
Sanofi-Synthelabo
Eli Lilly and Company
Investigators
| Principal Investigator: | Andrew Zhu, MD | Massachusetts General Hospital |
More Information
No publications provided
| Responsible Party: | Andrew Zhu, MD, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT00142467 History of Changes |
| Other Study ID Numbers: | 03-390 |
| Study First Received: | August 31, 2005 |
| Last Updated: | August 7, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Massachusetts General Hospital:
|
Unresectable hepatocellular carcinoma Metastatic hepatocellular carcinoma gemcitabine |
oxaliplatin bevacizumab Avastin |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Hepatocellular Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma Liver Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Liver Diseases Gemcitabine Oxaliplatin Bevacizumab Antimetabolites, Antineoplastic |
Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Radiation-Sensitizing Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances |
ClinicalTrials.gov processed this record on May 19, 2013