Ignite Creation Date:
2024-05-05 @ 5:20 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00436644
Status:
COMPLETED
Last Update Posted:
2014-04-16
First Post:
2007-02-15
Brief Title:
Lapatinib and Topotecan in Treating Patients With Ovarian Epithelial Cancer or Primary Peritoneal Cancer That Did Not Respond to Cisplatin or Carboplatin
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
A Phase II Trial of Lapatinib in Combination With Weekly Topotecan in Patients With Platinum-RefractoryResistant Ovarian and Primary Peritoneal Carcinoma
Status:
COMPLETED
Status Verified Date:
2014-03
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:
RATIONALE Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Drugs used in chemotherapy such as topotecan work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving lapatinib together with topotecan may kill more tumor cells
PURPOSE This phase II trial is studying how well giving lapatinib together with topotecan works in treating patients with ovarian epithelial cancer or primary peritoneal cancer that did not respond to cisplatin or carboplatin
PURPOSE This phase II trial is studying how well giving lapatinib together with topotecan works in treating patients with ovarian epithelial cancer or primary peritoneal cancer that did not respond to cisplatin or carboplatin
Detailed Description:
OBJECTIVES
Primary
Determine the efficacy of lapatinib ditosylate and topotecan hydrochloride in terms of response in patients with platinum-resistant or refractory ovarian epithelial or primary peritoneal cavity carcinoma
Secondary
Determine the overall survival time in patients treated with this regimen
Determine the time to progression in patients treated with this regimen
Assess the toxicity profile of this regimen in these patients
Translational
Determine the expression patterns of epidermal growth factor receptor HER2neu hypoxia-induced factor 1 alpha CD31 breast cancer resistance protein and topoisomerase I by immunohistochemistry using tumor tissue from primary debulking surgery
Determine the feasibility of monitoring circulating tumor cells with specific biological markers to determine or follow response in these patients
OUTLINE This is a multicenter study
Patients receive oral lapatinib ditosylate once daily on days 1-28 and topotecan hydrochloride IV over 30 minutes on days 1 8 and 15 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Blood samples are collected at baseline and on day 8 of course 1 immediately after the topotecan infusion and are evaluated for pharmacological studies Tumor tissue samples obtained at debulking surgery are examined by immunohistochemistry for epidermal growth factor receptor HER1 ErbB1 HER2neu ErbB2 hypoxia-induced factor 1 alpha CD31 platelet endothelial cell adhesion molecule 1 topoisomerase I and breast cancer resistance protein
After the completion of study treatment patients are followed periodically for 2 years
PROJECTED ACCRUAL A total of 39 patients will be accrued for this study
Primary
Determine the efficacy of lapatinib ditosylate and topotecan hydrochloride in terms of response in patients with platinum-resistant or refractory ovarian epithelial or primary peritoneal cavity carcinoma
Secondary
Determine the overall survival time in patients treated with this regimen
Determine the time to progression in patients treated with this regimen
Assess the toxicity profile of this regimen in these patients
Translational
Determine the expression patterns of epidermal growth factor receptor HER2neu hypoxia-induced factor 1 alpha CD31 breast cancer resistance protein and topoisomerase I by immunohistochemistry using tumor tissue from primary debulking surgery
Determine the feasibility of monitoring circulating tumor cells with specific biological markers to determine or follow response in these patients
OUTLINE This is a multicenter study
Patients receive oral lapatinib ditosylate once daily on days 1-28 and topotecan hydrochloride IV over 30 minutes on days 1 8 and 15 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Blood samples are collected at baseline and on day 8 of course 1 immediately after the topotecan infusion and are evaluated for pharmacological studies Tumor tissue samples obtained at debulking surgery are examined by immunohistochemistry for epidermal growth factor receptor HER1 ErbB1 HER2neu ErbB2 hypoxia-induced factor 1 alpha CD31 platelet endothelial cell adhesion molecule 1 topoisomerase I and breast cancer resistance protein
After the completion of study treatment patients are followed periodically for 2 years
PROJECTED ACCRUAL A total of 39 patients will be accrued for this study
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 |
|---|---|---|---|
| 06-002426 | OTHER | Mayo Clinic IRB | httpsreporternihgovquickSearchP30CA015083 |
| P30CA015083 | NIH | None | None |
| RC0661 | OTHER | None | None |