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Erlotinib in Treating Patients With Liver Cancer That Cannot be Surgically Removed Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Erlotinib in Treating Patients With Liver Cancer That Cannot be Surgically Removed conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Erlotinib in Treating Patients With Liver Cancer That Cannot be Surgically Removed Clinical research trials and Erlotinib in Treating Patients With Liver Cancer That Cannot be Surgically Removed healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Erlotinib in Treating Patients With Liver Cancer That Cannot be Surgically Removed. Erlotinib in Treating Patients With Liver Cancer That Cannot be Surgically Removed Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Erlotinib in Treating Patients With Liver Cancer That Cannot be Surgically Removed clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Erlotinib in Treating Patients With Liver Cancer That Cannot be Surgically Removed condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "E" Clinical Trials Conditions > Erlotinib in Treating Patients With Liver Cancer That Cannot be Surgically Removed  Erlotinib in Treating Patients With Liver Cancer That Cannot be Surgically Removed
Erlotinib in Treating Patients With Liver Cancer That Cannot be Surgically Removed
For Condition: adult primary hepatocellular carcinoma,advanced adult primary liver cancer,localized unresectable adult primary liver cancer
Status: Recruiting
Sponsor(s): M.D. Anderson Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. PURPOSE: Phase II trial to study the effectiveness of erlotinib in treating patients who have liver cancer that cannot be surgically removed.
Details: OBJECTIVES: - Determine the 16-week progression-free survival of patients with unresectable hepatocellular carcinoma treated with erlotinib. - Determine the objective response rate, rate and duration of stable disease, and time to progression in patients treated with this drug. - Determine the median and overall survival of patients treated with this drug. - Determine the pharmacokinetic and pharmacodynamic profiles of this drug in these patients. - Determine the safety and tolerability of this drug in these patients. - Correlate response to this drug with patient characteristics (e.g., age, disease stage, viral hepatitis status, pathologic grade of cirrhosis, Childs-Pugh status, performance status, serum values of alpha-fetoprotein, bilirubin, transaminases, and albumin, epidermal growth factor receptor expression, and development of skin rash during therapy). OUTLINE: Patients are stratified according to epidermal growth factor receptor expression (low, 0-1+ vs high, 2-3+). Patients receive oral erlotinib once daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 80 patients (40 per stratum) will be accrued for this study within 25-50 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed hepatocellular carcinoma (HCC) not amenable to curative resection - No fibrolamellar HCC - No prior therapy for HCC, including systemic chemotherapy, hepatic arterial infusion of chemotherapeutic agents or irradiated microspheres, and epidermal growth factor receptor-targeting agents - The following prior therapies are allowed provided previously treated lesions remain separate from those to be evaluated in present study - Surgery - Liver-directed therapy (e.g., radiofrequency ablation, transarterial embolization/chemoembolization, or percutaneous ethanol injection) - At least 1 unidimensionally measurable lesion - At least 20 mm by conventional techniques - Must have paraffin tissue block or unstained slides from biopsy or surgical specimen - No known brain metastases - No ascites that are refractory to conservative management (e.g., sodium restriction to 50 mEq/day dietary sodium and fluid restrictions and/or diuretics) PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - At least 16 weeks Hematopoietic - Granulocyte count at least 1,500/mm^3 - Platelet count at least 60,000/mm^3 - Hemoglobin at least 10 g/dL Hepatic - Bilirubin no greater than 1.8 mg/dL - Albumin at least 2.5 g/dL - AST/ALT no greater than 5 times upper limit of normal - PT no greater than 1-3 seconds over normal - No decompensated liver disease - No jaundice - No portosystemic encephalopathy (evidenced by confusion, asterixis, significant sleep disturbance, or hypothermia less than 36º Celsius) - No hyponatremia with sodium less than 125 mEq/L - No portal hypertension with bleeding esophageal or gastric varices within the past 3 months Renal - Creatinine no greater than 2 mg/dL Cardiovascular - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia Gastrointestinal - No gastrointestinal tract disease resulting in an inability to take oral medication or requirement for IV alimentation - No active peptic ulcer disease Ophthalmic - No abnormalities of the cornea (e.g., dry eye syndrome or Sjögren's syndrome) - No congenital abnormality (e.g., Fuch's dystrophy) Other - No other uncontrolled concurrent illness that would preclude study participation - No ongoing or active infection - No psychiatric illness or social situation that would preclude study compliance - No other malignancy within the past 5 years except nonmelanoma skin cancer - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - See Disease Characteristics Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - See Disease Characteristics - No prior surgical therapy affecting absorption Other - More than 30 days since prior investigational agents - No concurrent commercial or other investigational anticancer agents or therapies - No concurrent combination antiretroviral therapy for HIV-positive patients
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MelanieThomas, Study Chair, M.D. Anderson Cancer Center
University of Texas - MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030-4009
United States
Recruiting James Abbruzzese 713-792-2828
Additional Information:
Study ID Numbers: CDR0000257665; NCI-5953,MDA-ID-02008
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00047333
Other Localized Unresectable Adult Primary Liver Cancer Studies:
1. Thalidomide Plus Interferon alfa in Treating Patients With Progressive Liver Cancer That Cannot be Surgically Removed
2. T900607 in Treating Patients With Unresectable Liver Cancer
3. Gemcitabine Plus Docetaxel in Treating Patients With Unresectable or Metastatic Liver Cancer
4. Sho-Saiko-To Following Removal of Liver Cancer By Embolization in Treating Patients With Liver Cancer That Cannot Be Surgically Removed
5. Nolatrexed Dihydrochloride Compared With Doxorubicin in Treating Patients With Recurrent or Unresectable Liver Cancer
Related Studies:
Other localized unresectable adult primary liver cancer Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Erlotinib in Treating Patients With Liver Cancer That Cannot be Surgically Removed
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