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A Phase III Randomized Controlled Study Comparing the Survival of Patients With Unresectable Hepatocellular Carcinoma (HCC) Treated With THYMITAQ to Patients Treated With Doxorubicin


Phase 3
18 Years
N/A
Not Enrolling
Both
Liver Cancer

Thank you

Trial Information

A Phase III Randomized Controlled Study Comparing the Survival of Patients With Unresectable Hepatocellular Carcinoma (HCC) Treated With THYMITAQ to Patients Treated With Doxorubicin


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Safety Issue:

No

Principal Investigator

Gregory R. Suplick

Investigator Role:

Study Chair

Investigator Affiliation:

Eximias Pharmaceutical

Authority:

United States: Federal Government

Study ID:

ZARIX-ZX101-301

NCT ID:

NCT00012324

Start Date:

September 2000

Completion Date:

November 2005

Related Keywords:

  • Liver Cancer
  • localized unresectable adult primary liver cancer
  • advanced adult primary liver cancer
  • recurrent adult primary liver cancer
  • adult primary hepatocellular carcinoma
  • Liver Neoplasms
  • Carcinoma, Hepatocellular

Name

Location

University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
Medical City Dallas HospitalDallas, Texas  75230
Veterans Affairs Medical Center - Long BeachLong Beach, California  90822
New York Medical CollegeValhalla, New York  10595
Albert Einstein Cancer CenterPhiladelphia, Pennsylvania  19141
Joe Arrington Cancer Research and Treatment CenterLubbock, Texas  79410-1894
University of Miami Sylvester Comprehensive Cancer CenterMiami, Florida  33136
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
Siteman Cancer Center at Barnes-Jewish HospitalSaint Louis, Missouri  63110
Cancer Research Center of HawaiiHonolulu, Hawaii  96813
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
Veterans Affairs Medical Center - AlbuquerqueAlbuquerque, New Mexico  87108-5138
Hackensack University Medical CenterHackensack, New Jersey  07601
Arkansas Cancer Research Center at University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Herbert Irving Comprehensive Cancer Center at Columbia UniversityNew York, New York  10032
Alvin and Lois Lapidus Cancer Institute at Sinai HospitalBaltimore, Maryland  21215
Albert Einstein Cancer Center at Albert Einstein College of MedicineBronx, New York  10461
SUNY Upstate Medical University HospitalSyracuse, New York  13210
Scripps Cancer Center at Scripps ClinicLa Jolla, California  92037
Lombardi Cancer Center at Georgetown University Medical CenterWashington, District of Columbia  20007
UNMC Eppley Cancer Center at the University of Nebraska Medical CenterOmaha, Nebraska  68198-7680
New York Weill Cornell Cancer Center at Cornell UniversityNew York, New York  10021
University of Illinois at Chicago Cancer CenterChicago, Illinois  60612
Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicago, Illinois  60611
Saint Louis University Cancer CenterSaint Louis, Missouri  63110
Stanley S. Scott Cancer Center at Louisiana State University Medical Center - New OrleansNew Orleans, Louisiana  70112
Cancer Centers of the Carolinas - EastsideGreenville, South Carolina  29601
Arizona Clinical Research Center, IncorporatedTucson, Arizona  85715
Tower Cancer Research FoundationBeverly Hills, California  90211
David and Donna Long Center for Cancer Treatment at Sharp Grossmont HospitalLa Mesa, California  91942
California Pacific Medical Center - Pacific CampusSan Francisco, California  94115
Olive View - UCLA Medical Center FoundationSylmar, California  91342
California Hematology/Oncology Medical GroupTorrance, California  90505
Helen F. Graham Cancer CenterNewark, Delaware  19713
Florida Cancer Institute - Bayonet PointHudson, Florida  34667
Oncology-Hematology Group of South Florida, P.A.Miami, Florida  33176
Ocala Research Institute, IncorporatedOcala, Florida  34480
Louisiana Oncology Associates - LafayetteLafayette, Louisiana  70506