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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: Randomized phase III trial to compare the effectiveness of two different chemotherapy regimens in treating patients who have recurrent or unresectable liver cancer.
- 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.
Allocation: Randomized, Control: Active Control, Masking: Open Label, Primary Purpose: Treatment
doxorubicin hydrochloride, nolatrexed dihydrochloride
Arizona Clinical Research Center, Incorporated
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-07-24T14:35:08-0400
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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Interleukin-2 may stimulate a person's white blood cells to kill liv...
RATIONALE: Drugs used in chemotherapy, such as doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping the cells from dividing. Ch...
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RATIONALE: Drugs used in chemotherapy, such as doxorubicin, work in different ways to stop tumor cells from dividing so they stop growing or die. Bortezomib may stop the growth of tumor ce...
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Tumors or cancer of the LIVER.
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Antineoplastic antibiotic obtained from Streptomyces peucetius. It is a hydroxy derivative of DAUNORUBICIN.
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An anticholesteremic agent that inhibits sterol biosynthesis in animals.
Hepatology is the study of liver, gallbladder, biliary tree, and pancreas, and diseases associated with them. This includes viral hepatitis, alcohol damage, cirrhosis and cancer. As modern lifestyles change, with alcoholism and cancer becoming more promi...
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In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...