Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00113373
Status:
COMPLETED
Last Update Posted:
2019-07-24
First Post:
2005-06-07
Brief Title:
Lapatinib in Treating Patients With Persistent or Recurrent Ovarian Epithelial or Peritoneal Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Evaluation of Lapatinib GW572016 NCI-Supplied Agent NSC 727989 in the Treatment of Persistent or Recurrent Epithelial Ovarian or Primary Peritoneal Carcinoma
Status:
COMPLETED
Status Verified Date:
2019-07
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 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 works in treating patients with persistent or recurrent ovarian epithelial or peritoneal cancer
Detailed Description:
OBJECTIVES Primary I Determine 6-month progression-free survival of patients with persistent or recurrent ovarian epithelial or primary peritoneal cancer treated with lapatinib
II Determine the nature and degree of toxicity of this drug in these patients
Secondary I Determine the clinical response rate partial and complete response in patients treated with this drug
II Determine the duration of progression-free and overall survival of patients treated with this drug
III Determine the impact of prognostic variables including platinum sensitivity performance status and cellular histology clear cell or mucinous type on patients treated with this drug
IV Correlate tumor levels of expression of epidermal growth factor receptors EGFR phosphorylated EGFR HER2neu and Ki-67 as determined by immunohistochemistry with clinical response in patients treated with this drug
V Correlate EGFR mutations in tumor DNA with clinical response in patients treated with this drug
OUTLINE This is a multicenter study
Patients receive oral lapatinib once daily on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study therapy patients are followed every 3 months for 2 years and then every 6 months for 3 years
PROJECTED ACCRUAL A total of 22-60 patients will be accrued for this study within 12-26 months
II Determine the nature and degree of toxicity of this drug in these patients
Secondary I Determine the clinical response rate partial and complete response in patients treated with this drug
II Determine the duration of progression-free and overall survival of patients treated with this drug
III Determine the impact of prognostic variables including platinum sensitivity performance status and cellular histology clear cell or mucinous type on patients treated with this drug
IV Correlate tumor levels of expression of epidermal growth factor receptors EGFR phosphorylated EGFR HER2neu and Ki-67 as determined by immunohistochemistry with clinical response in patients treated with this drug
V Correlate EGFR mutations in tumor DNA with clinical response in patients treated with this drug
OUTLINE This is a multicenter study
Patients receive oral lapatinib once daily on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study therapy patients are followed every 3 months for 2 years and then every 6 months for 3 years
PROJECTED ACCRUAL A total of 22-60 patients will be accrued for this study within 12-26 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 |
|---|---|---|---|
| NCI-2012-02654 | REGISTRY | None | None |
| CDR0000429548 | None | None | None |
| GOG-0170G | OTHER | None | None |
| GOG-0170G | OTHER | None | None |
| U10CA027469 | NIH | CTEP | httpsreporternihgovquickSearchU10CA027469 |