Viewing Study NCT00436501



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Study NCT ID: NCT00436501
Status: COMPLETED
Last Update Posted: 2019-02-26
First Post: 2007-02-15

Brief Title: VEGF Trap and Docetaxel in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer Primary Peritoneal Cancer or Fallopian Tube Cancer
Sponsor: National Cancer Institute NCI
Organization: National Cancer Institute NCI

Study Overview

Official Title: Phase III and Pharmacokinetic Study of Docetaxel Plus VEGF Trap AVE0005 NSC 724770 in Patients With Recurrent Ovarian Primary Peritoneal and Fallopian Tube Cancer
Status: COMPLETED
Status Verified Date: 2019-02
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 III trial is studying the side effects and best dose of VEGF Trap when given together with docetaxel and to see how well they work in treating patients with persistent or recurrent ovarian epithelial cancer primary peritoneal cancer or fallopian tube cancer VEGF Trap may stop the growth of tumor cells by blocking blood flow to the tumor Drugs used in chemotherapy such as docetaxel work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving VEGF Trap together with docetaxel may kill more tumor cells
Detailed Description: PRIMARY OBJECTIVES

I Determine the safety and tolerability of VEGF Trap and docetaxel in patients with persistent or recurrent ovarian epithelial primary peritoneal or fallopian tube cancer Phase I closed to accrual as of 3142008 II Determine the maximum tolerated dose of VEGF Trap in these patients Phase I closed to accrual as of 3142008 III Determine the pharmacokinetics of VEGF Trap when administered alone and in combination with docetaxel in these patients Phase I closed to accrual as of 3142008 IV Determine the effects of VEGF Trap on tumor perfusion and metabolism in these patients Phase I closed to accrual as of 3142008 V Determine the effect of VEGF Trap and docetaxel on circulating endothelial precursors and circulating endothelial cells in these patients Phase I closed to accrual as of 3142008 VI Determine the frequency of clinical response partial response and complete response in patients treated with this regimen Phase II open to accrual as of 592008 VII Determine the progression-free survival PFS and overall survival OS of patients treated with this regimen Phase II open to accrual as of 592008

SECONDARY OBJECTIVES

I Determine the duration of PFS and OS of patients treated with this regimen Phase II II Determine the frequency and severity of adverse effects of this regimen in these patients Phase II III Determine the proportion of patients with PFS at 6 months Phase II

OUTLINE This is a multicenter phase I dose-escalation study of VEGF Trap followed by a phase II study

PHASE I closed to accrual as of 3142008 Patients receive VEGF Trap IV over 1 hour on day 1 of course 1 Patients then receive VEGF Trap IV over 1 hour and docetaxel IV over 1 hour on day 1 in all subsequent courses Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity

Cohorts of 3-6 patients receive escalating doses of VEGF Trap until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 or 6 patients experience dose-limiting toxicity

PHASE II opened to accrual as of 592008 Patients receive VEGF Trap at the MTD determined in phase I and docetaxel as in phase I Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity

Patients enrolled in phase I closed to accrual as of 3142008 undergo blood sample collection periodically for pharmacokinetic studies and surrogate marker studies These patients also undergo dynamic contrast-enhanced MRI fludeoxyglucose F 18 positron emission tomography and CT scan at baseline and on day 1 of courses 1 and 2 to evaluate blood flow parameters and metabolic activity of tumors Patients enrolled in phase I closed to accrual as of 3142008 and phase II will also undergo blood collection for Anti-VEGF trap antibody

After the completion of study treatment patients are followed at 1 and 2 months and then periodically thereafter

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
P50CA083639 NIH None httpsreporternihgovquickSearchP50CA083639
2006-0329 None None None