Ignite Creation Date:
2024-05-05 @ 5:03 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00379509
Status:
COMPLETED
Last Update Posted:
2017-03-21
First Post:
2006-09-20
Brief Title:
Lapatinib and Radiation Therapy in Treating Patients With Locally Recurrent or Chemotherapy-Refractory Locally Advanced or Metastatic Breast Cancer
Sponsor:
UNC Lineberger Comprehensive Cancer Center
Organization:
UNC Lineberger Comprehensive Cancer Center
Study Overview
Official Title:
Phase I Radiosensitization Study of GW572016 With Biologic Correlates in Locoregionally Recurrent Breast Cancer
Status:
COMPLETED
Status Verified Date:
2017-03
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 Radiation therapy uses high-energy x-rays to kill tumor cells Giving lapatinib together with radiation therapy may kill more tumor cells
PURPOSE This phase I trial is studying the side effects and best dose of lapatinib when given together with radiation therapy in treating patients with locally recurrent or chemotherapy-refractory locally advanced or metastatic breast cancer
PURPOSE This phase I trial is studying the side effects and best dose of lapatinib when given together with radiation therapy in treating patients with locally recurrent or chemotherapy-refractory locally advanced or metastatic breast cancer
Detailed Description:
OBJECTIVES
Primary
Determine the toxicity of lapatinib ditosylate and radiotherapy in patients with locally recurrent breast cancer or chemotherapy-refractory locally advanced or metastatic breast cancer
Determine the impact of this drug on inhibition of receptor and downstream signal transduction pathway activation in tumor tissue in the context of inhibitor dose escalation with or without radiotherapy
Secondary
Determine preliminarily the efficacy of lapatinib ditosylate and radiotherapy in these patients
Correlate response in these patients with inhibition of downstream signaling
Assess gene expression changes in tumor biopsy samples from patients treated with lapatinib ditosylate alone or in combination with radiotherapy
OUTLINE This is a multicenter parallel group dose-escalation study of lapatinib ditosylate Patients are stratified according to prior radiotherapy yes vs no
Group I prior radiotherapy Patients receive oral lapatinib ditosylate once daily in the absence of disease progression or unacceptable toxicity Beginning on day 8 of lapatinib ditosylate therapy patients undergo concurrent radiotherapy 5 days a week for up to 5 weeks
Group II no prior radiotherapy Patients receive oral lapatinib ditosylate as in group I Beginning on day 8 patients undergo concurrent radiotherapy 5 days a week for up to 7 weeks
In each group cohorts of 3-6 patients receive escalating doses of lapatinib ditosylate until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity during the first course
Patients undergo skin punch or core biopsy at baseline and on day 8 and day 15 Tumor biopsy samples are examined by IHC for evaluation of EGFR phospho-EGFR HER2 phospho-HER2 phospho-Akt and phospho-MAPK Samples are also examined for cell proliferation by Ki-67 apoptosis by TUNEL and angiogenesis by microvessel density Additionally mRNA is extracted from fresh frozen samples and examined by microarray analysis
NOTE Archival tissue acceptable for baseline sample if available
Primary
Determine the toxicity of lapatinib ditosylate and radiotherapy in patients with locally recurrent breast cancer or chemotherapy-refractory locally advanced or metastatic breast cancer
Determine the impact of this drug on inhibition of receptor and downstream signal transduction pathway activation in tumor tissue in the context of inhibitor dose escalation with or without radiotherapy
Secondary
Determine preliminarily the efficacy of lapatinib ditosylate and radiotherapy in these patients
Correlate response in these patients with inhibition of downstream signaling
Assess gene expression changes in tumor biopsy samples from patients treated with lapatinib ditosylate alone or in combination with radiotherapy
OUTLINE This is a multicenter parallel group dose-escalation study of lapatinib ditosylate Patients are stratified according to prior radiotherapy yes vs no
Group I prior radiotherapy Patients receive oral lapatinib ditosylate once daily in the absence of disease progression or unacceptable toxicity Beginning on day 8 of lapatinib ditosylate therapy patients undergo concurrent radiotherapy 5 days a week for up to 5 weeks
Group II no prior radiotherapy Patients receive oral lapatinib ditosylate as in group I Beginning on day 8 patients undergo concurrent radiotherapy 5 days a week for up to 7 weeks
In each group cohorts of 3-6 patients receive escalating doses of lapatinib ditosylate until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity during the first course
Patients undergo skin punch or core biopsy at baseline and on day 8 and day 15 Tumor biopsy samples are examined by IHC for evaluation of EGFR phospho-EGFR HER2 phospho-HER2 phospho-Akt and phospho-MAPK Samples are also examined for cell proliferation by Ki-67 apoptosis by TUNEL and angiogenesis by microvessel density Additionally mRNA is extracted from fresh frozen samples and examined by microarray analysis
NOTE Archival tissue acceptable for baseline sample if available
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 |
|---|---|---|---|
| P30CA016086 | NIH | None | httpsreporternihgovquickSearchP30CA016086 |