Nolatrexed Dihydrochloride Compared With Doxorubicin in Treating Patients With Recurrent or Unresectable Liver Cancer
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.
Drug: doxorubicin hydrochloride
Drug: nolatrexed dihydrochloride
|Study Design:||Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase III Randomized Controlled Study Comparing the Survival of Patients With Unresectable Hepatocellular Carcinoma (HCC) Treated With THYMITAQ to Patients Treated With Doxorubicin|
- Overall survival [ Designated as safety issue: No ]
- Time to progression [ Designated as safety issue: No ]
- Time to treatment failure [ Designated as safety issue: No ]
- Response rate (complete response, partial response, stable disease) [ Designated as safety issue: No ]
- Survival probabilities at 3, 6, 9, and 12 months [ Designated as safety issue: No ]
- Safety [ Designated as safety issue: Yes ]
- Response to treatment in patients with and without prior therapy [ Designated as safety issue: No ]
|Study Start Date:||September 2000|
|Study Completion Date:||November 2005|
- 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.
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|Study Chair:||Gregory R. Suplick||Eximias Pharmaceutical|