Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00217529
Status:
COMPLETED
Last Update Posted:
2010-09-21
First Post:
2005-09-20
Brief Title:
Erlotinib Docetaxel and Carboplatin in Treating Patients With Newly Diagnosed Stage III or Stage IV Ovarian Epithelial Primary Peritoneal Cavity or Fallopian Tube Cancer
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
A Phase I-II Study of OSI-774 Tarceva Erlotinib With DocetaxelCarboplatin Followed by Maintenance Therapy With Tarceva as Treatment for Newly Diagnosed Stage IIIIV Epithelial Ovarian Cancer Primary Peritoneal or Fallopian Tube Cancer
Status:
COMPLETED
Status Verified Date:
2010-09
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 Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Drugs used in chemotherapy such as docetaxel and carboplatin work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving erlotinib together with docetaxel and carboplatin may kill more tumor cells
PURPOSE This phase III trial is studying the side effects and best dose of erlotinib when given together with docetaxel and carboplatin and to see how well they work in treating patients with newly diagnosed stage III or stage IV ovarian epithelial primary peritoneal cavity or fallopian tube cancer
PURPOSE This phase III trial is studying the side effects and best dose of erlotinib when given together with docetaxel and carboplatin and to see how well they work in treating patients with newly diagnosed stage III or stage IV ovarian epithelial primary peritoneal cavity or fallopian tube cancer
Detailed Description:
OBJECTIVES
Primary
Determine the maximum tolerated dose MTD of erlotinib when administered in combination with docetaxel and carboplatin as front-line therapy in patients with newly diagnosed stage III or IV ovarian epithelial primary peritoneal cavity or fallopian tube cancer
Secondary
Determine the toxicity of maintenance therapy with erlotinib when administered after front-line therapy in these patients
Determine the proportion of patients who are able to receive the full schedule of treatment courses
Determine the objective response rate in patients with measurable or evaluable disease treated with this regimen
Determine the progression-free and overall survival of patients treated with this regimen
OUTLINE This is a multicenter dose-escalation study of erlotinib
Front-line therapy Patients receive docetaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1 pegfilgrastim subcutaneously on day 2 and oral erlotinib once daily on days 3-16 Treatment repeats every 21 days for up to 6 courses
Cohorts of 5 patients receive escalating doses of erlotinib until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 5 patients experience dose-limiting toxicity
Maintenance therapy Beginning 3-4 weeks after the completion of front-line therapy patients with stable or responding disease receive oral erlotinib once daily for up to 12 months
After completion of study treatment patients are followed every 6 months for 1 year and then periodically thereafter
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study
Primary
Determine the maximum tolerated dose MTD of erlotinib when administered in combination with docetaxel and carboplatin as front-line therapy in patients with newly diagnosed stage III or IV ovarian epithelial primary peritoneal cavity or fallopian tube cancer
Secondary
Determine the toxicity of maintenance therapy with erlotinib when administered after front-line therapy in these patients
Determine the proportion of patients who are able to receive the full schedule of treatment courses
Determine the objective response rate in patients with measurable or evaluable disease treated with this regimen
Determine the progression-free and overall survival of patients treated with this regimen
OUTLINE This is a multicenter dose-escalation study of erlotinib
Front-line therapy Patients receive docetaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1 pegfilgrastim subcutaneously on day 2 and oral erlotinib once daily on days 3-16 Treatment repeats every 21 days for up to 6 courses
Cohorts of 5 patients receive escalating doses of erlotinib until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 5 patients experience dose-limiting toxicity
Maintenance therapy Beginning 3-4 weeks after the completion of front-line therapy patients with stable or responding disease receive oral erlotinib once daily for up to 12 months
After completion of study treatment patients are followed every 6 months for 1 year and then periodically thereafter
PROJECTED ACCRUAL A total of 30 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 |
|---|---|---|---|
| CDR0000441312 | REGISTRY | PDQ | None |
| PSOC-2001 | None | None | None |
| AVENTIS-PSOC-2001 | None | None | None |
| PSOC-IRB-5689 | None | None | None |