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Nolatrexed Dihydrochloride Compared With Doxorubicin in Treating Patients With Recurrent or Unresectable Liver Cancer Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about Nolatrexed Dihydrochloride Compared With Doxorubicin in Treating Patients With Recurrent or Unresectable Liver Cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Nolatrexed Dihydrochloride Compared With Doxorubicin in Treating Patients With Recurrent or Unresectable Liver Cancer Clinical research trials and Nolatrexed Dihydrochloride Compared With Doxorubicin in Treating Patients With Recurrent or Unresectable Liver Cancer health trials happen in many 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 measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like Nolatrexed Dihydrochloride Compared With Doxorubicin in Treating Patients With Recurrent or Unresectable Liver Cancer. Nolatrexed Dihydrochloride Compared With Doxorubicin in Treating Patients With Recurrent or Unresectable Liver Cancer Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a Nolatrexed Dihydrochloride Compared With Doxorubicin in Treating Patients With Recurrent or Unresectable Liver Cancer clinical trial. Human subjects often get the best healthcare available for their Nolatrexed Dihydrochloride Compared With Doxorubicin in Treating Patients With Recurrent or Unresectable Liver Cancer condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "N" Clinical Trials Conditions > Nolatrexed Dihydrochloride Compared With Doxorubicin in Treating Patients With Recurrent or Unresectable Liver Cancer  Nolatrexed Dihydrochloride Compared With Doxorubicin in Treating Patients With Recurrent or Unresectable Liver Cancer
Nolatrexed Dihydrochloride Compared With Doxorubicin in Treating Patients With Recurrent or Unresectable Liver Cancer
For Condition: recurrent adult primary liver cancer,advanced adult primary liver cancer,localized unresectable adult primary liver cancer,adult primary hepatocellular carcinoma
Status: Recruiting
Sponsor(s): Eximias Pharmaceutical ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which chemotherapy regimen is more effective for liver cancer. PURPOSE: Randomizedphase III trial to compare the effectiveness of two different chemotherapy regimens in treating patients who have recurrent or unresectable liver cancer.
Details: OBJECTIVES: - Compare the overall survival in patients with unresectable or recurrent hepatocellular carcinoma treated with nolatrexed dihydrochloride vs doxorubicin. - Compare time to progression, time to treatment failure, and response rates in patients treated with these regimens. - Compare the probability of survival at 3, 6, 9, and 12 months in patients treated with these regimens. - Compare the safety and clinical benefit of these regimens in these patients. - Compare the response rates and survival of patients who have received prior therapy or no prior therapy after treatment with these two regimens. - Compare the rates of conversion from unresectable to resectable lesions in patients treated with these regimens. OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to CLIP score (0-1 vs 2-3) and Karnofsky performance status (60-70% vs 80-100%). Patients are randomized to one of two treatment arms. - Arm I: Patients receive nolatrexed dihydrochloride IV continuously on days 1-5. - Arm II: Patients receive doxorubicin IV on day 1. Treatment continues in both arms every 3 weeks in the absence of unacceptable toxicity or disease progression. Patients are followed every 2 months for survival. PROJECTED ACCRUAL: Approximately 446 patients (223 per treatment arm) will be accrued for this study within 12 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically proven or presumptive diagnosis of hepatocellular carcinoma - Presumptive diagnosis based on rising alpha-fetoprotein (AFP) levels over 2 assessments, CT scan or MRI of liver, spiral CT scan of portal/splenic vein, and biopsy evidence of cirrhosis - Unresectable or recurrent disease after prior surgical resection or embolization therapy - Fibrolamellar histology allowed if considered surgically unresectable based on tumor size, extrahepatic involvement, or multiple lobe involvement - CLIP (Cancer of the Liver Italian Program) score less than 4 - Concurrent assignment to a transplantation list allowed PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 60-100% Life expectancy: - Not specified Hematopoietic: - Absolute neutrophil count at least 1,200/mm^3 - Platelet count at least 80,000/mm^3 Hepatic: - Bilirubin no greater than 3.0 mg/dL (except for known Gilbert's Syndrome) - AST no greater than 5 times upper limit of normal (ULN) - PT no greater than 1.5 times ULN Renal: - Creatinine no greater than 2.0 mg/dL Cardiovascular: - No uncontrolled hypertension within the past 3 months - No unstable angina, symptomatic congestive heart failure, or myocardial infarction within the past 3 months - No uncontrolled cardiac arrhythmia Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No active bacterial infections - HIV negative - No AIDS - No other primary malignancy except carcinoma in situ of the cervix or urinary bladder or non-melanoma skin cancer - No mental incapacitation or psychiatric illness that would preclude study participation - No other severe disease that would preclude study participation - Candidate for placement of a central venous access device PRIOR CONCURRENT THERAPY: Biologic therapy: - Prior biologic therapy allowed - No concurrent biologic therapy Chemotherapy: - No prior IV doxorubicin except intraarterial administration in locoregional therapy Endocrine therapy: - Prior endocrine therapy allowed - No concurrent endocrine therapy Radiotherapy: - Prior radiotherapy allowed - No concurrent radiotherapy Surgery: - See Disease Characteristics - Surgery allowed if previously unresectable lesions become resectable - Recovered from any prior surgery - No concurrent liver transplantation Other: - No other concurrent investigational or marketed anticancer drugs - No other concurrent therapy for hepatocellular carcinoma - No concurrent terfenadine, astemizole, or cisapride that may not be interrupted during nolatrexed dihydrochloride administration
Total Enrollment:
Location and Contact Information:
Overall Study Official:
GregorySuplick, Study Chair, Eximias Pharmaceutical
Jonsson Comprehensive Cancer Center, UCLA *Recruiting*
Los Angeles, California, 90095-1781
United States
Recruiting Leland Powell 818-364-3205
New York Medical College *Recruiting*
Valhalla, New York, 10595
United States
Recruiting Hoo Chun 914-493-4400
Veterans Affairs Medical Center - Long Beach *Recruiting*
Long Beach, California, 90822
United States
Recruiting Padmini Iyer 562-826-5748
Ocala Research Institute, Inc *Recruiting*
Ocala, Florida, 34471
United States
Recruiting Mohammad Kamal 352-622-7008
Washington University School of Medicine *Recruiting*
St. Louis, Missouri, 63110
United States
Recruiting Joel Picus 314-747-1367
Herbert Irving Comprehensive Cancer Center at Columbia University *Recruiting*
New York City, New York, 10032
United States
Recruiting Kyriakos Papadopoulos 212-305-0787
Cancer Research Center of Hawaii *Recruiting*
Honolulu, Hawaii, 96813
United States
Recruiting Brian Issell 808-586-2979
Cleveland Clinic Taussig Cancer Center *Recruiting*
Cleveland, Ohio, 44111
United States
Recruiting Timothy Spiro 216-476-7606
Veterans Affairs Medical Center - Albuquerque *Recruiting*
Albuquerque, New Mexico, 87108
United States
Recruiting Antoine Jakiche 505-265-1711 Ext. 2480
Stanley S. Scott Cancer Center at Louisiana State University Medical Center - New Orleans *Recruiting*
New Orleans, Louisiana, 70112
United States
Recruiting Lowell Anthony 504-568-5843
Lombardi Cancer Center at Georgetown University Medical Center *Recruiting*
Washington D.C., District of Columbia, 20007
United States
Recruiting Jimmy Hwang 202-444-2198
Albert Einstein Cancer Center *Recruiting*
Philadelphia, Pennsylvania, 19141
United States
Recruiting John Leighton 215-456-8295
New York Weill Cornell Cancer Center at Cornell University *Recruiting*
New York City, New York, 10021
United States
Recruiting Scott Wadler 212-746-2844
Green Cancer Center at Scripps Clinic *Recruiting*
La Jolla, California, 92037
United States
Recruiting William Miller 858-554-8832
Louisiana Oncology Associates *Recruiting*
Lafayette, Louisiana, 70506
United States
Recruiting David Rinaldi 337-235-7898
University of Illinois Medical Center *Recruiting*
Chicago, Illinois, 60612
United States
Recruiting Divyesh Mehta 312-996-7975
Helen F. Graham Cancer Center at Christiana Care Health System *Recruiting*
Newark, Delaware, 19713
United States
Recruiting Irving Berkowitz 302-733-6249
University Hospital at State University of New York - Upstate Medical University *Recruiting*
Syracuse, New York, 13210
United States
Recruiting Jonathan Wright 315-464-8200
Cancer Centers of the Carolinas - Eastside *Recruiting*
Greenville, South Carolina, 29615
United States
Recruiting Jeffrey Giguere 864-987-7000
Holden Comprehensive Cancer Center at University of Iowa *Recruiting*
Iowa City, Iowa, 52242-1009
United States
Recruiting Mark Karwal 319-353-7900
St. Boniface General Hospital *Recruiting*
Winnipeg, Manitoba, R2H 2A6
Canada
Recruiting Charles Olweny 204-235-3016
Albert Einstein Clinical Cancer Center *Recruiting*
Bronx, New York, 10467
United States
Recruiting Andreas Kaubisch 718-920-7100
Medical City Dallas Hospital *Recruiting*
Dallas, Texas, 75230
United States
Recruiting Barry Mirtsching 972-566-5588
Tower Hematology Oncology Medical Group *Recruiting*
Los Angeles, California, 90048
United States
Recruiting Solomon Hamburg 310-854-9220
Sinai Hospital of Baltimore *Recruiting*
Baltimore, Maryland, 21215
United States
Recruiting Mukund Didolkar 410-601-8317
University of Minnesota *Recruiting*
Minneapolis, Minnesota, 55455
United States
Recruiting Edward Greeno 612-626-6418
Joe Arrington Cancer Research and Treatment Center *Recruiting*
Lubbock, Texas, 79410-1894
United States
Recruiting Jose Figueroa 806-725-8000
University of Arkansas for Medical Sciences *Recruiting*
Little Rock, Arkansas, 72205
United States
Recruiting Issam Makhoul 501-686-8511
Cancer Center at Hackensack University Medical Center *Recruiting*
Hackensack, New Jersey, 07601
United States
Recruiting Andrew Jennis 201-996-5900
California Hematology/Oncology Medical Group *Recruiting*
Torrance, California, 90505
United States
Recruiting Alex Makalinao 310-784-1709
Robert H. Lurie Comprehensive Cancer Center at Northwestern University *Recruiting*
Chicago, Illinois, 60611
United States
Recruiting Al Benson 312-695-1382
Louisiana State University Health Sciences Center - Shreveport *Recruiting*
Shreveport, Louisiana, 71130-3932
United States
Recruiting Prakash Neupane 318-675-5970
UNMC Eppley Cancer Center at the University of Nebraska Medical Center *Recruiting*
Omaha, Nebraska, 68198-7680
United States
Recruiting Margaret Kessinger 402-559-7511
University of Miami Sylvester Cancer Center *Recruiting*
Miami, Florida, 33136
United States
Recruiting Lynn Feun 305-243-4909
Coastal Hematology and Oncology, P.C. - Savannah *Recruiting*
Savannah, Georgia, 31406
United States
Recruiting Gail Shaw Wright 912-351-9500
Fundacion de Investagacion De Diego *Recruiting*
Santurce, , 00909
Puerto Rico
Recruiting Eileen Pacheco 787-722-1248
University of Wisconsin Comprehensive Cancer Center *Recruiting*
Madison, Wisconsin, 53792
United States
Recruiting James Thomas 608-265-8756
David and Donna Long Center for Cancer Treatment *Recruiting*
La Mesa, California, 91942
United States
Recruiting Warren Paroli 760-758-5770
Oncology-Hematology Group of South Florida *Recruiting*
Miami, Florida, 33176
United States
Recruiting Leonard Kalman 305-595-2141
Princess Margaret Hospital *Recruiting*
Toronto, Ontario, M5G 2M9
Canada
Recruiting Ronald Feld 416-946-2260
Arizona Clinical Research Center *Recruiting*
Tucson, Arizona, 85712
United States
Recruiting Manuel Modiano 520-290-2510
California Pacific Medical Center - Pacific Campus *Recruiting*
San Francisco, California, 94115
United States
Recruiting Robert Gish 415-600-1020
Ottawa Regional Cancer Centre *Recruiting*
Ottawa, Ontario, K1H 1C4
Canada
Recruiting Rakesh Goel 613-737-7700 ext. 6763
Additional Information:
Study ID Numbers: CDR0000068506; ZARIX-ZX101-301,AG-337-301
Study Start Date:
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00012324
Other Adult Primary Hepatocellular Carcinoma Studies:
1. Seocalcitol in Treating Patients With Advanced Hepatocellular Carcinoma
2. Erlotinib in Treating Patients With Liver Cancer That Cannot be Surgically Removed
3. SCH 66336 With or Without Gemcitabine Followed by Surgery Compared With Surgery Alone in Treating Patients With Primary Liver Cancer
4. DX-8951f in Treating Patients With Liver Cancer
5. Thalidomide Plus Interferon alfa in Treating Patients With Progressive Liver Cancer That Cannot be Surgically Removed
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Nolatrexed Dihydrochloride Compared With Doxorubicin in Treating Patients With Recurrent or Unresectable Liver Cancer
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