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Erlotinib in Treating Patients With Unresectable Liver, Bile Duct, or Gallbladder Cancer Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Erlotinib in Treating Patients With Unresectable Liver, Bile Duct, or Gallbladder Cancer conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Erlotinib in Treating Patients With Unresectable Liver, Bile Duct, or Gallbladder Cancer Clinical research trials and Erlotinib in Treating Patients With Unresectable Liver, Bile Duct, or Gallbladder Cancer healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Erlotinib in Treating Patients With Unresectable Liver, Bile Duct, or Gallbladder Cancer. Erlotinib in Treating Patients With Unresectable Liver, Bile Duct, or Gallbladder Cancer Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Erlotinib in Treating Patients With Unresectable Liver, Bile Duct, or Gallbladder Cancer clinical trial. Test subjects typically receive the most effective healthcare possible for their Erlotinib in Treating Patients With Unresectable Liver, Bile Duct, or Gallbladder Cancer condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health 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 Unresectable Liver, Bile Duct, or Gallbladder Cancer  Erlotinib in Treating Patients With Unresectable Liver, Bile Duct, or Gallbladder Cancer
Erlotinib in Treating Patients With Unresectable Liver, Bile Duct, or Gallbladder Cancer
For Condition: adult primary liver cancer,extrahepatic bile duct cancer,Gallbladder Cancer
Status: Suspended
Sponsor(s): Mayo Clinic Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Biological therapies such as erlotinib may interfere with the growth of cancer cells and slow the growth of the tumor. PURPOSE: Phase II trial to study the effectiveness of erlotinib in treating patients who have unresectableliver, bile duct, or gallbladder cancer.
Details: OBJECTIVES: - Determine the progression-free rate at 24 weeks in patients with unresectable hepatocellular or biliary carcinoma treated with erlotinib. - Determine the toxicity profile of this drug in these patients. - Determine the objective response rate of patients treated with this drug. - Determine the overall and progression-free survival of patients treated with this drug. - Correlate epidermal growth factor receptor protein levels with clinical outcome in patients treated with this drug. OUTLINE: This is a multicenter study. Patients are assigned to 1 of 2 groups according to cancer type (hepatocellular vs biliary). Patients receive oral erlotinib once daily. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for up to 3 years. PROJECTED ACCRUAL: A total of 78 patients (39 per group) 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: - Histologically or cytologically confirmed hepatocellular or biliary carcinoma - Unresectable - Noninvasive diagnosis of unresectable hepatocellular carcinoma byhypervascular mass on CT scan and alpha fetoprotein greater than 100 ng/mL allowed - Measurable disease - At least 1 lesion with diameter at least 2.0 cm - Child-Pugh classification of A or B - Indicator lesions must be outside of prior treatment area and edges of lesions must be clearly distinct - Patients whose sole indicator lesion is inside prior treatment area are eligible provided the lesion shows clear evidence of disease progression - No Ampulla of Vater tumors - No known CNS metastases PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 Life expectancy: - At least 3 months Hematopoietic: - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 75,000/mm^3 Hepatic: - Bilirubin no greater than 2 times upper limit of normal (ULN) - AST and ALT no greater than 3 times ULN - INR no greater than 1.5 (for patients not receiving anticoagulation) Renal: - Creatinine no greater than 2 mg/dL - Albumin at least 2.5 g/dL Cardiovascular: - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia Gastrointestinal: - No requirement for IV alimentation - No gastrointestinal tract disease resulting in an inability to take oral medication - No active peptic ulcer disease Ophthalmic: - No known abnormalities of the cornea including, but not limited to: - Dry eye syndrome or Sjögren's syndrome - Congenital abnormality (e.g., Fuch's dystrophy) - Abnormal slit-lamp examination using a vital dye (e.g., fluorescein or Bengal-Rose) - Abnormal corneal sensitivity test (Schirmer test or similar tear production test) Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No significant traumatic injury within the past 3 weeks - No other malignancy in the past 3 years except adequately treated basal cell or squamous cell skin cancer or carcinoma of the cervix - No ongoing or active infection - No uncontrolled concurrent medical or psychiatric illness or social situation that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy: - More than 4 weeks since prior immunotherapy or biologic therapy - No concurrent immunotherapy Chemotherapy: - More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) - No more than 1 prior systemic anticancer therapy - Chemoembolization considered 1 prior chemotherapeutic regimen - No concurrent chemotherapy Endocrine therapy: - No concurrent anti-cancer hormonal agents Radiotherapy: - More than 4 weeks since prior radiotherapy - No concurrent radiotherapy (including whole brain irradiation for documented CNS metastasis) Surgery: - More than 3 weeks since prior major surgery - More than 6 weeks since prior cryotherapy - No prior procedures affecting absorption Other: - Recovered from prior therapy - More than 6 weeks since prior radiofrequency ablation, ethanol injection, or photodynamic therapy - No prior epidermal growth factor receptor-targeting therapy - No concurrent combination anti-retroviral therapy for HIV-positive patients - No other concurrent investigational therapy or supportive care - No other concurrent anticancer medications
Total Enrollment:
Location and Contact Information:
Overall Study Official:
PhilipPhilip, Study Chair, Barbara Ann Karmanos Cancer Institute
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379
United States
Washington University School of Medicine
St. Louis, Missouri, 63110
United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792
United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-2410
United States
Mayo Clinic Scottsdale
Scottsdale, Arizona, 85259
United States
Mayo Clinic
Jacksonville, Florida, 32224
United States
Howard University Hospital
Washington D.C., District of Columbia, 20060-0001
United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
United States
Additional Information:
Study ID Numbers: CDR0000069285; MAYO-MC0152,NCI-5429
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00033462
Other Extrahepatic Bile Duct Cancer Studies:
1. Gene Therapy in Treating Patients With Cancer
2. BMS-247550 in Treating Patients With Liver or Gallbladder Cancer
3. Interleukin-12 in Treating Patients With Refractory Advanced-Stage Ovarian Cancer or Abdominal Cancer
4. Oxaliplatin With Or Without Floxuridine and Leucovorin in Treating Patients With Metastatic Cancer of the Peritoneum
5. Oxaliplatin Plus Irinotecan in Treating Patients With Metastatic Gastrointestinal Cancer
Related Studies:
Other extrahepatic bile duct cancer Clinical Trials
Other Minnesota Clinical Trials
Other Rochester Clinical Trials
Erlotinib in Treating Patients With Unresectable Liver, Bile Duct, or Gallbladder Cancer
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