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Gefitinib in Treating Patients With Advanced Unresectable Hepatocellular Carcinoma (Liver Cancer) 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 Gefitinib in Treating Patients With Advanced Unresectable Hepatocellular Carcinoma (Liver Cancer) conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Gefitinib in Treating Patients With Advanced Unresectable Hepatocellular Carcinoma (Liver Cancer) Clinical research trials and Gefitinib in Treating Patients With Advanced Unresectable Hepatocellular Carcinoma (Liver Cancer) 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 Gefitinib in Treating Patients With Advanced Unresectable Hepatocellular Carcinoma (Liver Cancer). Gefitinib in Treating Patients With Advanced Unresectable Hepatocellular Carcinoma (Liver Cancer) 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 Gefitinib in Treating Patients With Advanced Unresectable Hepatocellular Carcinoma (Liver Cancer) clinical trial. Human subjects often obtain the finest healthcare possible for their Gefitinib in Treating Patients With Advanced Unresectable Hepatocellular Carcinoma (Liver Cancer) 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 > "G" Clinical Trials Conditions > Gefitinib in Treating Patients With Advanced Unresectable Hepatocellular Carcinoma (Liver Cancer)  Gefitinib in Treating Patients With Advanced Unresectable Hepatocellular Carcinoma (Liver Cancer)
Gefitinib in Treating Patients With Advanced Unresectable Hepatocellular Carcinoma (Liver Cancer)
For Condition: adult primary hepatocellular carcinoma,recurrent adult primary liver cancer,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: Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. PURPOSE: Phase II trial to study the effectiveness of gefitinib in treating patients who have advanced unresectablehepatocellular carcinoma (liver cancer ).
Details: OBJECTIVES: Primary - Determine the 4.5-month progression-free survival rate in patients with advanced unresectable hepatocellular carcinoma treated with gefitinib. Secondary - Determine the response rate (complete and partial), in terms of the effects of this drug on measurable disease and serum alpha-fetoprotein levels, in these patients. - Determine the overall survival of patients treated with this drug. - Determine the toxicity of this drug in these patients. - Correlate epidermal growth factor expression at baseline with clinical response in patients treated with this drug. OUTLINE: This is a multicenter study. Patients receive oral gefitinib daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed for 3 years from study entry. PROJECTED ACCRUAL: A total of 23-59 patients will be accrued for this study within 19 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of advanced unresectable hepatocellular carcinoma based on 1 of the following criteria: - Histologically or cytologically confirmed disease - Hepatitis B surface antigen negative and alpha-fetoprotein greater than 400 ng/mL - Hepatitis B surface antigen positive and alpha-fetoprotein greater than 4,000 ng/mL - At least 1 unidimensionally measurable lesion - At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan - Outside prior radiotherapy field - No known brain metastases - Ineligible for surgical resection or liver transplantation PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - Not specified Hematopoietic - WBC at least 2,000/mm^3 - Absolute neutrophil count at least 1,000/mm^3 - Platelet count at least 50,000/mm^3 Hepatic - See Disease Characteristics - Bilirubin no greater than 2 times upper limit of normal (ULN) - AST no greater than 5 times ULN - PT no greater than 6 seconds over control - INR no greater than 2.3 - Albumin at least 2.8 g/dL - No Child Pugh Scale class C cirrhosis Renal - Creatinine normal OR - Creatinine clearance at least 60 mL/min Cardiovascular - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No other active malignancy requiring therapy except nonmelanoma skin cancer - No prior allergic reactions attributed to compounds of similar chemical or biological composition to gefitinib - No psychiatric illness or social situation that would preclude study compliance - No grade 3 or 4 encephalopathy - No other concurrent uncontrolled illness - No ongoing or active infection PRIOR CONCURRENT THERAPY: Biologic therapy - No prior biologic therapy - Prior interferon alfa or interferon beta for hepatitis B or C allowed provided the therapy was completed before the diagnosis of hepatocellular carcinoma - No prior antiangiogenesis therapy Chemotherapy - No prior systemic chemotherapy Endocrine therapy - No concurrent dexamethasone - No concurrent glucocorticoids - No concurrent progesterone Radiotherapy - See Disease Characteristics - At least 2 weeks since prior palliative radiotherapy Surgery - Not specified Other - Prior liver-directed therapy (i.e., radiofrequency ablation, cryoablation, percutaneous ethanol injection, chemo-embolization, hepatic artery embolization, and hepatic artery-infused floxuridine) allowed provided patient has progressive hepatic disease or measurable extrahepatic disease - No prior epidermal growth factor inhibitor therapy - No other concurrent investigational or commercial anticancer agents or therapies - No concurrent combination antiretroviral therapy for HIV-positive patients - No concurrent inducers of CYP3A4, including the following: - Carbamazepine - Ethosuximide - Griseofulvin - Nafcillin - Nelfinavir - Nevirapine - Oxcarbazepine - Phenobarbital - Phenylbutazone - Phenytoin - Primidone - Rifabutin - Rifampin - Rofecoxib - Hypericum perforatum (St. John's wort) - Sulfadimidine - Sulfinpyrazone - Troglitazone - Efavirenz - Modafinil - Rifapentine
Total Enrollment:
Location and Contact Information:
Overall Study Official:
BruceGiantonio, Study Chair, University of Pennsylvania Health Systems
CCOP - Northern New Jersey *Recruiting*
Hackensack, New Jersey, 07601
United States
Recruiting Richard Rosenbluth 201-996-5917
Cleveland Clinic Taussig Cancer Center *Recruiting*
Cleveland, Ohio, 44195
United States
Recruiting Robert Dreicer 216-445-4623
Cancer Institute of New Jersey *Recruiting*
New Brunswick, New Jersey, 08903
United States
Recruiting Joseph Aisner 732-235-7464
CCOP - Ochsner *Recruiting*
New Orleans, Louisiana, 70121
United States
Recruiting Carl Kardinal 504-842-3910
CCOP - Marshfield Clinic Research Foundation *Recruiting*
Marshfield, Wisconsin, 54449
United States
Recruiting Tarit Banerjee 715-387-5134
CCOP - Oklahoma *Recruiting*
Tulsa, Oklahoma, 74136
United States
Recruiting James Lockhart 918-491-5878
Hillman Cancer Center at University of Pittsburgh Cancer Institute *Recruiting*
Pittsburgh, Pennsylvania, 15236
United States
Recruiting John Kirkwood 412-692-4724
Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus *Recruiting*
Nashville, Tennessee, 37212-2637
United States
Recruiting Kenneth Hande 615-327-4751
Winship Cancer Institute of Emory University *Recruiting*
Atlanta, Georgia, 30322
United States
Recruiting William Wood 404-778-5180
Veterans Affairs Medical Center - Omaha *Recruiting*
Omaha, Nebraska, 68105
United States
Recruiting James Mailliard 402-280-5274
CCOP - Kalamazoo *Recruiting*
Kalamazoo, Michigan, 49007-3731
United States
Recruiting Raymond Lord 269-373-7488
Indiana University Cancer Center *Recruiting*
Indianapolis, Indiana, 46202-5289
United States
Recruiting Patrick Loehrer 317-278-7418
MBCCOP - University of New Mexico HSC *Recruiting*
Albuquerque, New Mexico, 87131
United States
Recruiting Cynthia Cathcart 505-272-5688
CCOP - Christiana Care Health Services *Recruiting*
Newark, Delaware, 19713
United States
Recruiting Stephen Grubbs 302-623-4100
Burgess Health Center *Recruiting*
Onawa, Iowa, 51040
United States
Recruiting James Mailliard 712-423-2311
Des Moines General Hospital *Recruiting*
Des Moines, Iowa, 50309
United States
Recruiting Roscoe Morton 515-247-3121
Iowa Lutheran Hospital *Recruiting*
Des Moines, Iowa, 50316-2301
United States
Recruiting Roscoe Morton 515-663-5612
CCOP - Scott and White Hospital *Recruiting*
Temple, Texas, 76508
United States
Recruiting Lucas Wong 254-724-7048
CCOP - Cedar Rapids Oncology Project *Recruiting*
Cedar Rapids, Iowa, 52403-1206
United States
Recruiting Martin Wiesenfeld 319-363-8303
CCOP - Geisinger Clinic and Medical Center *Recruiting*
Danville, Pennsylvania, 17822-2001
United States
Recruiting Suresh Nair 570-271-6413
CCOP - Metro-Minnesota *Recruiting*
St. Louis Park, Minnesota, 55416
United States
Recruiting Patrick Flynn 952-993-15175
University of Wisconsin Comprehensive Cancer Center *Recruiting*
Madison, Wisconsin, 53792-0001
United States
Recruiting James Stewart 608-265-8131
Norris Cotton Cancer Center at Dartmouth Medical School *Recruiting*
Lebanon, New Hampshire, 03756-0002
United States
Recruiting Camilo Fadul 603-650-6312
Veterans Affairs Medical Center - Milwaukee (Zablocki) *Recruiting*
Milwaukee, Wisconsin, 53295
United States
Recruiting Mohammed Raheem 414-384-2000
CCOP - MainLine Health *Recruiting*
Wynnewood, Pennsylvania, 19096
United States
Recruiting Paul Gilman 610-645-2057
Beth Israel Deaconess Medical Center *Recruiting*
Boston, Massachusetts, 02215
United States
Recruiting Michael Atkins 617-667-1930
NYU School of Medicine's Kaplan Comprehensive Cancer Center *Recruiting*
New York City, New York, 10016
United States
Recruiting Howard Hochster 212-652-1912
John Stoddard Cancer Center at Iowa Methodist Medical Center *Recruiting*
Des Moines, Iowa, 50309
United States
Recruiting Roscoe Morton 515-241-4245
University of Minnesota Cancer Center *Recruiting*
Minneapolis, Minnesota, 55455
United States
Recruiting George Adams 612-625-2410
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center *Recruiting*
Nashville, Tennessee, 37232-6307
United States
Recruiting David Johnson 615-343-9454
Veterans Affairs Medical Center - Palo Alto *Recruiting*
Palo Alto, California, 94304-1290
United States
Recruiting Harlan Pinto 650-493-5000 ext. 4948
CCOP - St. Vincent Hospital Cancer Center, Green Bay *Recruiting*
Green Bay, Wisconsin, 54307-3453
United States
Recruiting Gerald Bayer 920-433-8889
MBCCOP - San Juan *Recruiting*
San Juan, , 00921-3201
Puerto Rico
Recruiting Luis Baez-Diaz 787-641-3693
Veterans Affairs Medical Center - Minneapolis *Recruiting*
Minneapolis, Minnesota, 55417-2399
United States
Recruiting Markus Gapany 612-725-2000 ext. 3459
Stanford Cancer Center at Stanford University Medical Center *Recruiting*
Stanford, California, 94305-5216
United States
Recruiting Harlan Pinto 650-725-9057
Penn State Cancer Institute at Milton S. Hershey Medical Center *Recruiting*
Hershey, Pennsylvania, 17033-0850
United States
Recruiting Witold Rybka 717-531-1050
CCOP - Duluth *Recruiting*
Duluth, Minnesota, 55805
United States
Recruiting Robert Dalton 218-786-8364
Veterans Affairs Medical Center - Gainesville *Recruiting*
Gainesville, Florida, 32608-1197
United States
Recruiting Dean McCarley 352-374-6016
Mayo Clinic Cancer Center *Recruiting*
Rochester, Minnesota, 55905
United States
Recruiting Thomas Habermann 507-284-2511
Veterans Affairs Medical Center - East Orange *Recruiting*
East Orange, New Jersey, 07019
United States
Recruiting Basil Kasimis 973-676-1000 ext. 1544
CCOP - Central Illinois *Recruiting*
Decatur, Illinois, 62526
United States
Recruiting James Wade 217-876-6617
University of Alabama at Birmingham Comprehensive Cancer Center *Recruiting*
Birmingham, Alabama, 35294-3300
United States
Recruiting Carla Falkson 205-975-2691
Veterans Affairs Medical Center - Wichita *Recruiting*
Wichita, Kansas, 67218
United States
Recruiting Shaker Dakhil 316-685-2221
Veterans Affairs Medical Center - New York *Recruiting*
New York City, New York, 10010
United States
Recruiting Howard Hochster 212-652-1912
CCOP - Carle Cancer Center *Recruiting*
Urbana, Illinois, 61801
United States
Recruiting Kendrith Rowland 217-383-4083
Medical College of Wisconsin Cancer Center *Recruiting*
Milwaukee, Wisconsin, 53226-3596
United States
Recruiting David Vesole 414-805-4646
MetroHealth Medical Center *Recruiting*
Cleveland, Ohio, 44109
United States
Recruiting Edward Mansour 216-778-4394
Mercy Cancer Center at Mercy Medical Center-Des Moines *Recruiting*
Des Moines, Iowa, 50314
United States
Recruiting Roscoe Morton 515-247-3121
MBCCOP - LSU Health Sciences Center *Recruiting*
New Orleans, Louisiana, 70112
United States
Recruiting Jill Gilbert 504-568-5136
Westmead Hospital *Recruiting*
Westmead, New South Wales, 2145
Australia
Recruiting Richard Kefford 61-2-9845-6033
MBCCOP - Howard University Cancer Center *Recruiting*
Washington D.C., District of Columbia, 20060
United States
Recruiting Lucile Adams-Campbell 202-806-7697
Veterans Affairs Medical Center - Indianapolis (Roudebush) *Recruiting*
Indianapolis, Indiana, 46202
United States
Recruiting Patrick Loehrer 317-554-0000
Midlands Cancer Center at Midlands Community Hospital *Recruiting*
Papillion, Nebraska, 68128-4157
United States
Recruiting James Mailliard 402-593-3000
MBCCOP-Our Lady of Mercy Cancer Center *Recruiting*
Bronx, New York, 10466
United States
Recruiting Peter Wiernik 718-920-1100
CCOP - Merit Care Hospital *Recruiting*
Fargo, North Dakota, 58122
United States
Recruiting Preston Steen 701-234-6161
Veterans Affairs Medical Center - Miami *Recruiting*
Miami, Florida, 33125
United States
Recruiting Niramol Savaraj 305-324-3143
H. Lee Moffitt Cancer Center and Research Institute *Recruiting*
Tampa, Florida, 33612-9497
United States
Recruiting Cancer Answers 800-456-7121
CCOP - Illinois Oncology Research Association *Recruiting*
Peoria, Illinois, 61602
United States
Recruiting John Kugler 309-636-3605
CCOP - Wichita *Recruiting*
Wichita, Kansas, 67214-3882
United States
Recruiting Shaker Dakhil 316-268-5784
Pretoria Academic Hospital *Recruiting*
Pretoria, , 0001
South Africa
Recruiting Coenraad Slabber 27-12-354-1054
CCOP - Missouri Valley Cancer Consortium *Recruiting*
Omaha, Nebraska, 68106
United States
Recruiting James Mailliard 402-280-4364
Veterans Affairs Medical Center - Brooklyn *Recruiting*
Brooklyn, New York, 11209
United States
Recruiting Andrea Wiesel Leaf 718-630-3691
Drexel University Hospital *Recruiting*
Philadelphia, Pennsylvania, 19102-1192
United States
Recruiting Pamela Crilley 215-762-8547
Veterans Affairs Medical Center - Lakeside Chicago *Recruiting*
Chicago, Illinois, 60611-4494
United States
Recruiting Timothy Kuzel 312-469-3748
CCOP - Columbus *Recruiting*
Columbus, Ohio, 43206
United States
Recruiting J. Kuebler 614-488-2118
CCOP - Iowa Oncology Research Association *Recruiting*
Des Moines, Iowa, 50309-1016
United States
Recruiting Roscoe Morton 515-244-7586
Fox Chase Cancer Center *Recruiting*
Philadelphia, Pennsylvania, 19111-2497
United States
Recruiting Lori Goldstein 215-728-2689
Tufts - New England Medical Center *Recruiting*
Boston, Massachusetts, 02111
United States
Recruiting John Erban 617-636-5147
City of Hope Comprehensive Cancer Center *Recruiting*
Duarte, California, 91010-3000
United States
Recruiting Theodore Krontiris 626-301-8164
Albert Einstein Clinical Cancer Center *Recruiting*
Bronx, New York, 10461
United States
Recruiting Joseph Sparano 718-904-2555
Robert H. Lurie Comprehensive Cancer Center at Northwestern University *Recruiting*
Chicago, Illinois, 60611
United States
Recruiting Al Benson 312-695-1382
CCOP - Colorado Cancer Research Program, Incorporated *Recruiting*
Denver, Colorado, 80224
United States
Recruiting Eduardo Pajon 303-777-2663
CCOP - Sioux Community Cancer Consortium *Recruiting*
Sioux Falls, South Dakota, 57104
United States
Recruiting Loren Tschetter 605-328-8044
CCOP - Mayo Clinic Scottsdale Oncology Program *Recruiting*
Scottsdale, Arizona, 85259-5404
United States
Recruiting Tom Fitch 480-301-9875
CCOP - Evanston *Recruiting*
Evanston, Illinois, 60201
United States
Recruiting Gershon Locker 847-570-2518
CCOP - Southern Nevada Cancer Research Foundation *Recruiting*
Las Vegas, Nevada, 89106
United States
Recruiting John Ellerton 702-384-0013
Veterans Affairs Medical Center - San Juan *Recruiting*
San Juan, , 00927-5800
Puerto Rico
Recruiting Luis Baez-Diaz 787-641-3693
Veterans Affairs Medical Center - Atlanta (Decatur) *Recruiting*
Decatur, Georgia, 30033
United States
Recruiting Maria Amarante Ribeiro 404-728-7680
CCOP - Toledo Community Hospital *Recruiting*
Toledo, Ohio, 43623-3456
United States
Recruiting Paul Schaefer 419-843-6147
Abramson Cancer Center at University of Pennsylvania Medical Center *Recruiting*
Philadelphia, Pennsylvania, 19104
United States
Recruiting Daniel Haller 215-662-6318
CCOP - Northern Indiana CR Consortium *Recruiting*
South Bend, Indiana, 46601
United States
Recruiting Rafat Ansari 574-284-7977
CCOP - Michigan Cancer Research Consortium *Recruiting*
Ann Arbor, Michigan, 48106
United States
Recruiting Philip Stella 734-712-2000
San Juan City Hospital *Recruiting*
San Juan, , 00936-7344
Puerto Rico
Recruiting Luis Baez-Diaz 787-641-3693
Veterans Affairs Medical Center - Pittsburgh *Recruiting*
Pittsburgh, Pennsylvania, 15240
United States
Recruiting Timothy Carlos 412-688-6248
Veterans Affairs Medical Center - Madison *Recruiting*
Madison, Wisconsin, 53705
United States
Recruiting Mark Albertini 608-262-7017
Instituto de Enfermedades Neoplasicas *Recruiting*
Lima, , 34
Peru
Recruiting Carlos Vallejos-Sologuren 51-14-499-137
Veterans Affairs Medical Center - Tampa (Haley) *Recruiting*
Tampa, Florida, 33612
United States
Recruiting Julie Kish 813-972-2000
Additional Information:
Study ID Numbers: CDR0000335058; ECOG-E1203
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00071994
Other Adult Primary Hepatocellular Carcinoma Studies:
1. Hepatic Arterial Infusion Plus Internal Radiation Therapy in Treating Patients With Liver Cancer That Cannot Be Removed By Surgery
2. Doxorubicin and Interleukin-2 in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery
3. Gemcitabine Plus Docetaxel in Treating Patients With Unresectable or Metastatic Liver Cancer
4. Epirubicin and Thalidomide in Treating Patients With Liver Cancer
5. Vaccine Therapy in Treating Patients With Liver Cancer
Related Studies:
Other adult primary hepatocellular carcinoma Clinical Trials
Other New Jersey Clinical Trials
Other Hackensack Clinical Trials
Gefitinib in Treating Patients With Advanced Unresectable Hepatocellular Carcinoma (Liver Cancer)
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