Ignite Creation Date:
2024-05-05 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00107536
Status:
COMPLETED
Last Update Posted:
2015-04-29
First Post:
2005-04-05
Brief Title:
Lapatinib Ditosylate in Treating Patients With Unresectable Liver or Biliary Tract Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of Efficacy and Tolerability of GW572016 in Patients With Advanced Hepatocellular and Biliary Carcinomas
Status:
COMPLETED
Status Verified Date:
2015-03
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:
Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth This phase II trial is studying how well lapatinib ditosylate works in treating patients with unresectable liver or biliary tract cancer
Detailed Description:
PRIMARY OBJECTIVES
I To evaluate the objective response rate complete response CR partial response PR as defined by the Response Evaluation Criteria in Solid Tumors RECIST criteria in each group of patients
SECONDARY OBJECTIVES
I To evaluate the progression free survival at 6 months II To evaluate the toxicity profile of this treatment in each group of patients
III To evaluate median overall survival 6 and 12 months survival rates IV To assess target-epidermal growth factor receptor EGFREGFR-P protein expression and the genes that regulate the cell cycle and apoptosis which are either downstream of or cross-talk with the EGFR signaling pathway to explore their association with clinical outcome
V To measure expression profile and mutations of genes critical for EGFR and v-erb-b2 erythroblastic leukemia viral oncogene homolog 2 ERBB2 signaling pathways with particular relevance to GW572016 and to explore new gene-drug relationships as relating to hepatocellular and biliary carcinomas
OUTLINE This is a multicenter study
Patients receive oral lapatinib ditosylate once daily on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 70 patients will be accrued for this study within 1 year
I To evaluate the objective response rate complete response CR partial response PR as defined by the Response Evaluation Criteria in Solid Tumors RECIST criteria in each group of patients
SECONDARY OBJECTIVES
I To evaluate the progression free survival at 6 months II To evaluate the toxicity profile of this treatment in each group of patients
III To evaluate median overall survival 6 and 12 months survival rates IV To assess target-epidermal growth factor receptor EGFREGFR-P protein expression and the genes that regulate the cell cycle and apoptosis which are either downstream of or cross-talk with the EGFR signaling pathway to explore their association with clinical outcome
V To measure expression profile and mutations of genes critical for EGFR and v-erb-b2 erythroblastic leukemia viral oncogene homolog 2 ERBB2 signaling pathways with particular relevance to GW572016 and to explore new gene-drug relationships as relating to hepatocellular and biliary carcinomas
OUTLINE This is a multicenter study
Patients receive oral lapatinib ditosylate once daily on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 70 patients will be accrued for this study within 1 year
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000420830 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchN01CM62201 |
| OSU 0447 | None | None | None |
| N01CM62207 | NIH | None | None |
| N01CM62201 | NIH | None | None |