|
Bortezomib in Treating Patients With Hepatocellular Carcinoma (Liver Cancer) Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about Bortezomib in Treating Patients With Hepatocellular Carcinoma (Liver Cancer) conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Bortezomib in Treating Patients With Hepatocellular Carcinoma (Liver Cancer) Clinical research trials and Bortezomib in Treating Patients With Hepatocellular Carcinoma (Liver Cancer) medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as Bortezomib in Treating Patients With Hepatocellular Carcinoma (Liver Cancer). Bortezomib in Treating Patients With Hepatocellular Carcinoma (Liver Cancer) Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a Bortezomib in Treating Patients With Hepatocellular Carcinoma (Liver Cancer) clinical trial. Subjects often receive the most expert healthcare possible for their Bortezomib in Treating Patients With Hepatocellular Carcinoma (Liver Cancer) condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "B" Clinical Trials Conditions > Bortezomib in Treating Patients With Hepatocellular Carcinoma (Liver Cancer)  Bortezomib in Treating Patients With Hepatocellular Carcinoma (Liver Cancer)
Bortezomib in Treating Patients With Hepatocellular Carcinoma (Liver Cancer)
For Condition: recurrent adult primary liver cancer,adult primary hepatocellular carcinoma,advanced adult primary liver cancer,localized unresectable adult primary liver cancer
Status: Recruiting
Sponsor(s): Eastern Cooperative Oncology Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. PURPOSE: Phase II trial to study the effectiveness of bortezomib in treating patients who have hepatocellular carcinoma (liver cancer).
Details: OBJECTIVES: Primary - Determine the tumor response rate in patients with hepatocellular carcinoma treated with bortezomib. Secondary - Determine other parameters of antitumor effect, including time to tumor progression and overall survival, in patients treated with this drug. - Determine the toxicity profile of this drug in these patients. - Compare proteasome 20S inhibition in tumor tissue (including proteins such as p21, p27, p53, Bax, and Bcl-2, that are affected by proteasome 26S) with clinical parameters using biopsy specimens from patients treated with this drug. - Determine phosphorylation of IkB in tumor tissue of patients treated with this drug. - Compare phosphorylation of IkB in tumor tissue with clinical parameters using biopsy specimens obtained from patients treated with this drug. - Determine the effect of this drug on 26S proteasome activity in peripheral white blood cells and serum of these patients. OUTLINE: This is a multicenter study. Patients receive bortezomib IV over 3-5 minutes on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years and then every 6 months for 1 year. PROJECTED ACCRUAL: A total of 38 patients will be accrued for this study within 13 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Microscopically confirmed hepatocellular carcinoma (HCC) not amenable to curative surgery - Measurable disease amenable to biopsy PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - Not specified Hematopoietic - Absolute neutrophil count 1,500/mm^3 (without splenomegaly) OR 1,000/mm^3 (with splenomegaly) - Platelet count 100,000/mm^3 (without splenomegaly) OR 75,000/mm^3 (with splenomegaly) - No known bleeding diathesis Hepatic - AST 5 times upper limit of normal (ULN) - Alkaline phosphatase 5 times ULN - Bilirubin 2.0 mg/dL - INR 1.5* - PTT 1.5 times ULN* - No Child-Pugh scale class C cirrhosis NOTE: *No vitamin K or fresh frozen plasma to correct laboratory values just prior to biopsy or study enrollment Renal - Creatinine 2.0 mg/dL Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No known allergy to boron, mannitol, or bortezomib - No peripheral neuropathy > grade 1 - No history of other untreated malignancy - No underlying medical condition that would preclude study participation - No psychiatric illness or continued alcohol abuse that would preclude study compliance and giving informed consent - No other malignancy within the past 5 years except carcinoma in situ of the cervix or previously treated squamous cell or basal cell skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy - No concurrent prophylactic hematopoietic growth factors Chemotherapy - No prior systemic chemotherapy for HCC - No prior chemoembolization - At least 4 weeks since prior antineoplastics for non-malignant disease (e.g., methotrexate for rheumatoid arthritis) and recovered Endocrine therapy - No prior tamoxifen for HCC Radiotherapy - Not specified Surgery - Not specified Other - Prior embolization (without chemotherapy), ethanol injection, radiofrequency ablation, or cryosurgery allowed provided there is documented disease progression within the involved lesion or at least 1 previously untreated lesion amenable to biopsy - No prior octreotide for HCC
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JordanBerlin, Study Chair, Vanderbilt-Ingram Cancer Center
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center *Recruiting*
Nashville, Tennessee, 37232-6307
United States
Recruiting David Johnson 615-343-9454
NYU School of Medicine's Kaplan Comprehensive Cancer Center *Recruiting*
New York City, New York, 10016
United States
Recruiting Howard Hochster 212-652-1912
Abramson Cancer Center at University of Pennsylvania Medical Center *Recruiting*
Philadelphia, Pennsylvania, 19104
United States
Recruiting Daniel Haller 215-662-6318
Fox Chase Cancer Center *Recruiting*
Philadelphia, Pennsylvania, 19111-2497
United States
Recruiting Lori Goldstein 215-728-2689
Robert H. Lurie Comprehensive Cancer Center at Northwestern University *Recruiting*
Chicago, Illinois, 60611
United States
Recruiting Al Benson 312-695-1382
Additional Information:
Study ID Numbers: CDR0000363801; ECOG-E6202
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00083226
Other Adult Primary Hepatocellular Carcinoma Studies:
1. TAC-101 in Treating Patients With Advanced Hepatocellular Carcinoma (Liver Cancer)
2. Combination Chemotherapy in Treating Patients With Unresectable or Metastatic Biliary Tract or Gallbladder Cancer
3. Epirubicin and Thalidomide in Treating Patients With Liver Cancer
4. Gefitinib in Treating Patients With Advanced Unresectable Hepatocellular Carcinoma (Liver Cancer)
5. Seocalcitol in Treating Patients With Advanced Hepatocellular Carcinoma
Related Studies:
Other adult primary hepatocellular carcinoma Clinical Trials
Other Pennsylvania Clinical Trials
Other Philadelphia Clinical Trials
Bortezomib in Treating Patients With Hepatocellular Carcinoma (Liver Cancer)
|
|
|
|
|
|
|
|
