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Erlotinib in Treating Patients With Unresectable Liver Cancer and Liver Dysfunction Clinical Trials Resources presented on Clinical Trials Search is not meant to be a substitute for proven health advice, calls or treatment with a real medical. We aren't mDs. Always consult your doctor on Erlotinib in Treating Patients With Unresectable Liver Cancer and Liver Dysfunction conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Erlotinib in Treating Patients With Unresectable Liver Cancer and Liver Dysfunction Clinical research trials and Erlotinib in Treating Patients With Unresectable Liver Cancer and Liver Dysfunction healthcare trials take place in a lot of of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectiveness of new does drugs. The function of the studies / projects is to figure out specific human medical questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to find cures for all varieties of conditions, like Erlotinib in Treating Patients With Unresectable Liver Cancer and Liver Dysfunction. Erlotinib in Treating Patients With Unresectable Liver Cancer and Liver Dysfunction Clinical Trials and other clinical trials allow volunteers to access health treatment options before they are available to the masses. Many times the subjects receive professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Erlotinib in Treating Patients With Unresectable Liver Cancer and Liver Dysfunction clinical trial. Human subjects often obtain the finest healthcare possible for their Erlotinib in Treating Patients With Unresectable Liver Cancer and Liver Dysfunction condition. Hazards are a reality, nevertheless, and might include additional or frequent dr. calls, health hazards (potentially life-jeopardizing), and/or the treatment being uneffective. Trials are federally regulated with stern guidelines to protect clinical trials patients.
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Home > "E" Clinical Trials Conditions > Erlotinib in Treating Patients With Unresectable Liver Cancer and Liver Dysfunction  Erlotinib in Treating Patients With Unresectable Liver Cancer and Liver Dysfunction
Erlotinib in Treating Patients With Unresectable Liver Cancer and Liver Dysfunction
For Condition: advanced adult primary liver cancer,localized unresectable adult primary liver cancer,recurrent adult primary liver cancer,adult primary hepatocellular carcinoma
Status: Recruiting
Sponsor(s): M.D. Anderson Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Biological therapies such as erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor. PURPOSE: Phase I trial to study the effectiveness of erlotinib in treating patients who have unresectable liver cancer and liver dysfunction.
Details: OBJECTIVES: - Determine the maximum tolerated dose of erlotinib in patients with unresectable hepatocellular carcinoma and moderate hepatic dysfunction. - Determine the dose-limiting toxicity of this drug in these patients. - Determine the pharmacokinetic and pharmacodynamic profiles of this drug in these patients. - Determine any possible antitumor effects of this drug in these patients. OUTLINE: This is a dose-escalation study. Patients receive oral erlotinib once daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. PROJECTED ACCRUAL: Approximately 12-24 patients will be accrued for this study within 4-24 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed unresectable hepatocellular carcinoma (HCC) with or without extrahepatic metastasis - No fibrolamellar HCC - No more than 2 prior therapies for HCC, including systemic chemotherapy, chemoembolization, hepatic arterial infusion of chemotherapeutic agents, and other novel agents - At least 1 unidimensionally measurable lesion - At least 20 mm by conventional techniques OR - At least 10 mm by spiral CT scan - Moderate hepatic dysfunction with any of the following: - Bilirubin 2-3 mg/dL - Albumin less than 2.5 g/dL - Mild ascites (not requiring serial paracenteses) - PT 2-4 seconds greater than upper limit of normal (ULN) - AST/ALT 2.6-5 times greater than ULN - 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 - See Disease Characteristics - No decompensated liver disease - No jaundice - No portosystemic encephalopathy (evidenced by confusion, asterixis, significant sleep disturbance, or hypothermia less than 36º Celsius) - No hyponatremia less than 130 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 Sjogren's syndrome) - No congenital abnormality (e.g., Fuch's dystrophy) - No abnormal slit-lamp examination using a vital dye (e.g., fluorescein or Bengal-Rose) - No abnormal corneal sensitivity test (e.g., Schirmer test or similar tear production test) Other - No significant traumatic injury within the past 21 days - 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 - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - See Disease Characteristics - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered Endocrine therapy - Not specified Radiotherapy - At least 4 weeks since prior radiotherapy and recovered Surgery - No prior surgical therapy affecting absorption - At least 21 days since prior major surgery Other - No prior epidermal growth factor receptor-targeting therapies - No other 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:
JamesAbbruzzese, 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: CDR0000257666; MDA-ID-01510,NCI-5349
Study Start Date:
Record last reviewed: January 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00047346
Other Localized Unresectable Adult Primary Liver Cancer Studies:
1. Epirubicin and Thalidomide in Treating Patients With Liver Cancer
2. Hepatic Arterial Infusion Plus Internal Radiation Therapy in Treating Patients With Liver Cancer That Cannot Be Removed By Surgery
3. Vaccine Therapy in Treating Patients With Liver Cancer
4. Combination Chemotherapy in Treating Patients With Unresectable or Metastatic Biliary Tract or Gallbladder Cancer
5. SCH 66336 With or Without Gemcitabine Followed by Surgery Compared With Surgery Alone in Treating Patients With Primary 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 Unresectable Liver Cancer and Liver Dysfunction
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