Upstate Active Clinical Trials Seeking Participants
Study title
Phase III Randomized Study of Sorafenib (IND 69896, NSC 724772) Plus Doxorubicin Versus Sorafenib in Patients with Advanced Hepatocellular Carcinoma (HCC)
IRB number
CIRB113
What is the purpose of the study?
The purpose of this study is to compare the effects (good and bad) of the drug sorafenib with the combination of sorafenib plus doxorubicin on subjects and their advanced primary liver cancer to find out which is better
Who is eligible?
Diagnosis of locally advanced or metastatic hepatocellular carcinoma, Child-Pugh score of A, No prior allografts including, but not limited to, liver or bone marrow transplants,No prior adjuvant therapy with sorafenib or other Raf/VEGFR inhibitors, Other prior adjuvant therapy is allowed provided it was completed > 6 months ago AND there is documented recurrence of HCC, No prior systemic therapy for metastatic disease, At least 4 weeks since prior locoregional therapy (e.g., embolization, chemoembolization [except with doxorubicin hydrochloride], radiotherapy, or radioactive microspheres), No prior local therapy for the target lesion unless the target lesion located within the field of local therapy has shown e 25% increase in size since last treatment, At least 4 weeks since prior interferon therapy,At least 4 weeks since prior major surgery, At least 4 weeks since prior and no concurrent rifampin or St John's wort , At least 4 weeks since prior and no concurrent palliative radiotherapy, Prior antiviral treatment allowed, No concurrent combination anti-retroviral therapy for HIV, No concurrent hormonal therapy or other chemotherapy, except for the following: Steroids administered for adrenal failure, Hormones administered for non-disease-related conditions (e.g., insulin for diabetes), Intermittent use of dexamethasone as an antiemetic; no clinically significant cardiac disease, adequate bone marrow, liver and kidney function tests.
What is involved if I participate?
- How long is the study?
Subjects will continue to receive study treatment until their doctor feels they are no longer benefiting from treatment or they experience side effects that prevent them from continuing. After subjects finish taking the study drugs, the doctor will continue to follow their progress every 3 months for one year and then every 6 months for two years for a total of 3 years. - Is transportation provided or reimbursed?
No - Is parking provided or reimbursed?
No - What tests and procedures are involved?
Physical exam, Blood tests for blood counts, electrolytes, kidney function, and liver function; Chest/abdomen/pelvis CT scans, pregnancy test, ECG, MUGA scan
Who is the doctor administering the study?
Jonathan Wright, MD
Where will the study take place?
University Hospital, Hematology/Oncology Clinics in Oswego, Oneida and Hill Medical Center
Over what time period is the study scheduled to run?
4/2010-4/2012
Who can I contact for more information?
- Name: Michelle Klick
- Phone: 315-464-8271
- Email: klickm@upstate.edu
- Fax: 315-464-8291
If you are interested in this trial, please contact the study coordinator or investigator noted above.
