Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00079430
Status:
COMPLETED
Last Update Posted:
2019-07-22
First Post:
2004-03-08
Brief Title:
Paclitaxel Bevacizumab And Adjuvant Intraperitoneal Carboplatin in Treating Patients Who Had Initial Debulking Surgery for Stage II Stage III or Stage IV Ovarian Epithelial Primary Peritoneal or Fallopian Tube Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Dose-Escalating Phase I Study With an Expanded Cohort to Assess the Feasibility of Intraperitoneal Carboplatin NSC 214240 and Intravenous Paclitaxel NSC 673089 and Intravenous Paclitaxel Intraperitoneal Carboplatin and NCI Supplied Intravenous Bevacizumab NSC 704865 in Patients With Previously Untreated Epithelial Ovarian Primary Peritoneal or Fallopian Tube Carcinoma
Status:
COMPLETED
Status Verified Date:
2019-07
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 I trial is studying the side effects and best dose of adjuvant intraperitoneal carboplatin when given together with paclitaxel and bevacizumab in treating patients who have undergone debulking surgery for stage II stage III or stage IV ovarian epithelial primary peritoneal or fallopian tube cancer Drugs used in chemotherapy such as carboplatin and paclitaxel work in different ways to stop tumor cells from dividing so they stop growing or die Monoclonal antibodies such as bevacizumab can block tumor growth in different ways Some block the ability of tumor cells to grow and spread Others find tumor cells and help kill them or carry tumor-killing substances to them Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor It is not yet known whether carboplatin paclitaxel and bevacizumab are more effective than carboplatin and paclitaxel in treating ovarian epithelial or primary peritoneal cancer or fallopian tube cancer
Detailed Description:
PRIMARY OBJECTIVES
I Determine the maximum tolerated dose of intraperitoneal carboplatin when administered with paclitaxel during course 1 in patients with stage II-IV ovarian epithelial primary peritoneal or fallopian tube cancer who had initial debulking surgery
II Determine the feasibility of this regimen in these patients III Determine the feasibility of adding IV bevacizumab to this regimen in courses 2-6
SECONDARY OBJECTIVES
I Determine the toxicity profile of this regimen in these patients II Determine the toxicity profile of paclitaxel and bevacizumab IV in combination with intraperitoneal carboplatin in these patients
III Determine the response rate in patients with measurable disease who are in the expanded cohort and progression-free survival of patients treated with this regimen
OUTLINE This is a multicenter dose-escalation study of intraperitoneal carboplatin
Patients receive paclitaxel IV over 3 hours followed by intraperitoneal carboplatin over 15 minutes on day 1 in course 1 Beginning in course 2 patients also receive bevacizumab IV over 30-90 minutes on day 1 Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of carboplatin 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 Once the MTD is determined an additional 20-40 patients are treated at that dose level
Patients are followed every 3 months for 1 year
I Determine the maximum tolerated dose of intraperitoneal carboplatin when administered with paclitaxel during course 1 in patients with stage II-IV ovarian epithelial primary peritoneal or fallopian tube cancer who had initial debulking surgery
II Determine the feasibility of this regimen in these patients III Determine the feasibility of adding IV bevacizumab to this regimen in courses 2-6
SECONDARY OBJECTIVES
I Determine the toxicity profile of this regimen in these patients II Determine the toxicity profile of paclitaxel and bevacizumab IV in combination with intraperitoneal carboplatin in these patients
III Determine the response rate in patients with measurable disease who are in the expanded cohort and progression-free survival of patients treated with this regimen
OUTLINE This is a multicenter dose-escalation study of intraperitoneal carboplatin
Patients receive paclitaxel IV over 3 hours followed by intraperitoneal carboplatin over 15 minutes on day 1 in course 1 Beginning in course 2 patients also receive bevacizumab IV over 30-90 minutes on day 1 Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of carboplatin 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 Once the MTD is determined an additional 20-40 patients are treated at that dose level
Patients are followed every 3 months for 1 year
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 |
|---|---|---|---|
| NCI-2009-00620 | REGISTRY | None | None |
| GOG-9917 | None | None | None |
| CDR0000355741 | None | None | None |
| GOG-9917 | OTHER | None | None |
| GOG-9917 | OTHER | None | None |
| U10CA027469 | NIH | CTEP | httpsreporternihgovquickSearchU10CA027469 |