Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00012324
Status:
COMPLETED
Last Update Posted:
2013-06-26
First Post:
2001-03-03
Brief Title:
Nolatrexed Dihydrochloride Compared With Doxorubicin in Treating Patients With Recurrent or Unresectable Liver Cancer
Sponsor:
Eximias Pharmaceutical
Organization:
National Cancer Institute NCI
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2005-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
PURPOSE Randomized phase III trial to compare the effectiveness of two different chemotherapy regimens in treating patients who have recurrent or unresectable liver cancer
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000068506 | REGISTRY | None | None |
| AG-337-301 | Registry Identifier | PDQ Physician Data Query | None |