Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00060307
Status:
COMPLETED
Last Update Posted:
2013-02-28
First Post:
2003-05-06
Brief Title:
Erlotinib in Treating Patients With Locally Advanced or Metastatic Papillary Renal Cell Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of OSI-774 NSC-718781 in Patients With Locally Advanced or Metastatic Papillary Histology Renal Cell Cancer
Status:
COMPLETED
Status Verified Date:
2013-02
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:
This phase II trial is studying how well erlotinib works in treating patients with locally advanced or metastatic papillary renal cell kidney cancer Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth
Detailed Description:
PRIMARY OBJECTIVES
I To assess response confirmed complete and partial response of patients with locally advanced or metastatic papillary histology renal cell cancer treated with OSI-774
II To assess the overall survival and 6-month probability of treatment failure of this group of patients
III To evaluate the qualitative and quantitative toxicities of this regimen IV To investigate in a preliminary manner the association of tumor response with tumor expression of epidermal growth factor receptor and status of von Hippel Lindau gene mutation
OUTLINE
Patients receive oral erlotinib once daily on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 1 year and then every 6 months for 2 years
PROJECTED ACCRUAL A total of 20-40 patients will be accrued for this study within 5-20 months
I To assess response confirmed complete and partial response of patients with locally advanced or metastatic papillary histology renal cell cancer treated with OSI-774
II To assess the overall survival and 6-month probability of treatment failure of this group of patients
III To evaluate the qualitative and quantitative toxicities of this regimen IV To investigate in a preliminary manner the association of tumor response with tumor expression of epidermal growth factor receptor and status of von Hippel Lindau gene mutation
OUTLINE
Patients receive oral erlotinib once daily on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 1 year and then every 6 months for 2 years
PROJECTED ACCRUAL A total of 20-40 patients will be accrued for this study within 5-20 months
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 |
|---|---|---|---|
| CDR0000301594 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU10CA032102 |
| S0317 | None | None | None |
| U10CA032102 | NIH | None | None |