Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00059787
Status:
COMPLETED
Last Update Posted:
2015-12-01
First Post:
2003-05-06
Brief Title:
Erlotinib Plus Carboplatin and Paclitaxel in Ovarian Carcinoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Study of Erlotinib Plus Carboplatin and Paclitaxel in Patients With Ovarian Fallopian Tube or Primary Peritoneal Carcinoma
Status:
COMPLETED
Status Verified Date:
2013-05
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 the side effects of giving erlotinib together with carboplatin and paclitaxel and to see how well it works in treating patients with stage III or stage IV ovarian fallopian tube or primary peritoneal cancer Biological therapies such as erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor Drugs used in chemotherapy such as carboplatin and paclitaxel use different ways to stop tumor cells from dividing so they stop growing or die
Detailed Description:
PRIMARY OBJECTIVES
I To establish whether the addition of OSI-774 Tarceva to the combination of paclitaxel and carboplatin encourages pathologic complete response pCR rates in patients with Stage III optimally cytoreduced stratum 1 and Stage III suboptimally cytoreduced or Stage IV stratum 2 ovarian primary peritoneal or fallopian tube carcinomas when used as front line therapy
II To determine the degree and type of toxicity associated with this combined regimen
SECONDARY OBJECTIVES
I To establish baseline epidermal growth factor receptor EGFR truncated EGFR EGFRvIII phosphorylated EGFR pEGFR and related signal transduction pathway protein expression levels such as the mitogen activated protein kinase p-ERK AKT phosphorylation and Her2neu in tumor samples obtained pretreatment and to correlate these with achieving pCR
II To describe changes in EGFR EGFRvIII pEGFR expression levels and other related signal transduction pathway expression occurring during treatment with OSI-774 in combination with chemotherapy
III To determine the effect of the addition of OSI-774 Tarceva to the combination of paclitaxel and carboplatin on progression-free interval in patients with Stage III optimally cytoreduced stratum 1 and Stage III suboptimally cytoreduced or Stage IV stratum 2 ovarian or primary peritoneal carcinomas when used as front line therapy
IV To determine the tolerability of twelve months of maintenance treatment with OSI-774 for patients achieving pCR and to measure the progression-free interval for this population
V To document cutaneous effects of OSI 774 prospectively and to correlate the degree of skin rash with clinical and translational endpoints
OUTLINE This is a non-randomized study Patients are stratified according to disease stage stage III with optimal residual disease vs stage III with suboptimal residual disease or stage IV
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 Patients also receive oral erlotinib daily Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity Patients who achieve a pathologic complete response those initially suboptimally debulked with a response and patients who elect not to undergo surgical reassessment but who achieve a complete clinical response receive maintenance erlotinib for an additional 12 months
I To establish whether the addition of OSI-774 Tarceva to the combination of paclitaxel and carboplatin encourages pathologic complete response pCR rates in patients with Stage III optimally cytoreduced stratum 1 and Stage III suboptimally cytoreduced or Stage IV stratum 2 ovarian primary peritoneal or fallopian tube carcinomas when used as front line therapy
II To determine the degree and type of toxicity associated with this combined regimen
SECONDARY OBJECTIVES
I To establish baseline epidermal growth factor receptor EGFR truncated EGFR EGFRvIII phosphorylated EGFR pEGFR and related signal transduction pathway protein expression levels such as the mitogen activated protein kinase p-ERK AKT phosphorylation and Her2neu in tumor samples obtained pretreatment and to correlate these with achieving pCR
II To describe changes in EGFR EGFRvIII pEGFR expression levels and other related signal transduction pathway expression occurring during treatment with OSI-774 in combination with chemotherapy
III To determine the effect of the addition of OSI-774 Tarceva to the combination of paclitaxel and carboplatin on progression-free interval in patients with Stage III optimally cytoreduced stratum 1 and Stage III suboptimally cytoreduced or Stage IV stratum 2 ovarian or primary peritoneal carcinomas when used as front line therapy
IV To determine the tolerability of twelve months of maintenance treatment with OSI-774 for patients achieving pCR and to measure the progression-free interval for this population
V To document cutaneous effects of OSI 774 prospectively and to correlate the degree of skin rash with clinical and translational endpoints
OUTLINE This is a non-randomized study Patients are stratified according to disease stage stage III with optimal residual disease vs stage III with suboptimal residual disease or stage IV
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 Patients also receive oral erlotinib daily Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity Patients who achieve a pathologic complete response those initially suboptimally debulked with a response and patients who elect not to undergo surgical reassessment but who achieve a complete clinical response receive maintenance erlotinib for an additional 12 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 |
|---|---|---|---|
| N01CM62204 | NIH | New York University | httpsreporternihgovquickSearchN01CM62204 |
| NYU 02-30 | OTHER | None | None |