Ignite Creation Date:
2024-05-05 @ 12:11 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00262847
Status:
COMPLETED
Last Update Posted:
2019-07-23
First Post:
2005-12-06
Brief Title:
Carboplatin and Paclitaxel With or Without Bevacizumab in Treating Patients With 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 Phase III Trial of Carboplatin and Paclitaxel Plus Placebo Versus Carboplatin and Paclitaxel Plus Concurrent Bevacizumab NSC 704865 Followed by Placebo Versus Carboplatin and Paclitaxel Plus Concurrent and Extended Bevacizumab in Women With Newly Diagnosed Previously Untreated Stage III or IV Epithelial Ovarian Primary Peritoneal or Fallopian Tube Cancer
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 randomized phase III trial studies carboplatin paclitaxel and bevacizumab to see how well they work compared to carboplatin paclitaxel and placebo in treating patients with 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 the growth of tumor cells either by killing the cells or by stopping them from dividing Monoclonal antibodies such as bevacizumab may interfere with the ability of tumor cells to grow and spread It is not yet known whether carboplatin paclitaxel and bevacizumab are more effective than carboplatin paclitaxel and placebo in treating ovarian epithelial primary peritoneal or fallopian tube cancer
Detailed Description:
PRIMARY OBJECTIVE
I To determine if the addition of 5 concurrent cycles of bevacizumab to 6 cycles of standard therapy carboplatin and paclitaxel Arm II increases the duration of progression-free survival PFS when compared to 6 cycles of standard therapy alone Arm I in women with newly diagnosed stage III with any gross residual disease and stage IV epithelial ovarian peritoneal primary or fallopian tube cancer
II To determine if the addition of 5 concurrent cycles of bevacizumab plus extended bevacizumab for 16 cycles beyond the 6 cycles of standard therapy carboplatin and paclitaxel Arm III increases progression-free survival when compared to 6 cycles of standard therapy Arm I in women with newly diagnosed stage III with any gross residual disease and stage IV epithelial ovarian peritoneal primary or fallopian tube cancer
SECONDARY OBJECTIVES
I In the event that both Arm II and Arm III regimens are superior to the Arm I regimen with respect to progression-free survival to determine whether the Arm III regimen prolongs progression-free survival when compared to the Arm II regimen
II To determine whether the Arm II or Arm III regimen increases the duration of overall survival when compared with the Arm I regimen
III To compare each of the experimental regimens to the Arm I regimen with respect to the incidence of severe toxicities or serious adverse events
IV To determine the impact on Quality of Life QOL as measured by the Functional Assessment of Cancer Therapy-Ovarian FACT-O trial outcome index TOI following treatment with the above regimens
TERTIARY OBJECTIVES
I To assess the relationship between angiogenic markers and clinical outcome including tumor response progression-free survival and overall survival in patients randomized to standard cytotoxic chemotherapy paclitaxel and carboplatin without bevacizumab with concurrent bevacizumab or with extended bevacizumab
II To assess the predictive value of a set of genes whose expression correlates with survival of patients with stage III with any gross residual disease and stage IV epithelial ovarian peritoneal primary or fallopian tube cancer
III To bank whole blood for research IV To determine if genetic variations in genes associated with essential hypertension including WNK lysine deficient protein kinase 1 WNK1 G protein-coupled receptor kinase 4 GRK4 and kallikrein B KLKB1 predict which patients are likely to develop bevacizumab-induced hypertension
OUTLINE Patients are randomized to 1 of 3 treatment arms
ARM I Patients receive paclitaxel intravenously IV over 3 hours and carboplatin IV over 30 minutes on day 1 Beginning in course 2 patients also receive placebo IV over 30-90 minutes on day 1 Treatment repeats every 21 days for 6 courses Beginning in course 7 patients receive placebo alone IV over 30-90 minutes on day 1 Treatment with placebo repeats every 21 days for up to 22 courses in the absence of disease progression or unacceptable toxicity
ARM II Patients receive paclitaxel and carboplatin as in arm I Beginning in course 2 patients also receive bevacizumab IV over 30-90 minutes on day 1 Treatment repeats every 21 days for 6 courses Beginning in course 7 patients receive placebo alone IV over 30-90 minutes on day 1 Treatment with placebo repeats every 21 days for up to 22 courses in the absence of disease progression or unacceptable toxicity
ARM III Patients receive paclitaxel and carboplatin as in arm I Beginning in course 2 patients also receive bevacizumab IV over 30-90 minutes on day 1 Treatment repeats every 21 days for 6 courses Beginning in course 7 patients receive bevacizumab alone IV over 30-90 minutes on day 1 Treatment with bevacizumab repeats every 21 days for up to 22 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every 3 months for 2 years every 6 months for 3 years and then annually thereafter
I To determine if the addition of 5 concurrent cycles of bevacizumab to 6 cycles of standard therapy carboplatin and paclitaxel Arm II increases the duration of progression-free survival PFS when compared to 6 cycles of standard therapy alone Arm I in women with newly diagnosed stage III with any gross residual disease and stage IV epithelial ovarian peritoneal primary or fallopian tube cancer
II To determine if the addition of 5 concurrent cycles of bevacizumab plus extended bevacizumab for 16 cycles beyond the 6 cycles of standard therapy carboplatin and paclitaxel Arm III increases progression-free survival when compared to 6 cycles of standard therapy Arm I in women with newly diagnosed stage III with any gross residual disease and stage IV epithelial ovarian peritoneal primary or fallopian tube cancer
SECONDARY OBJECTIVES
I In the event that both Arm II and Arm III regimens are superior to the Arm I regimen with respect to progression-free survival to determine whether the Arm III regimen prolongs progression-free survival when compared to the Arm II regimen
II To determine whether the Arm II or Arm III regimen increases the duration of overall survival when compared with the Arm I regimen
III To compare each of the experimental regimens to the Arm I regimen with respect to the incidence of severe toxicities or serious adverse events
IV To determine the impact on Quality of Life QOL as measured by the Functional Assessment of Cancer Therapy-Ovarian FACT-O trial outcome index TOI following treatment with the above regimens
TERTIARY OBJECTIVES
I To assess the relationship between angiogenic markers and clinical outcome including tumor response progression-free survival and overall survival in patients randomized to standard cytotoxic chemotherapy paclitaxel and carboplatin without bevacizumab with concurrent bevacizumab or with extended bevacizumab
II To assess the predictive value of a set of genes whose expression correlates with survival of patients with stage III with any gross residual disease and stage IV epithelial ovarian peritoneal primary or fallopian tube cancer
III To bank whole blood for research IV To determine if genetic variations in genes associated with essential hypertension including WNK lysine deficient protein kinase 1 WNK1 G protein-coupled receptor kinase 4 GRK4 and kallikrein B KLKB1 predict which patients are likely to develop bevacizumab-induced hypertension
OUTLINE Patients are randomized to 1 of 3 treatment arms
ARM I Patients receive paclitaxel intravenously IV over 3 hours and carboplatin IV over 30 minutes on day 1 Beginning in course 2 patients also receive placebo IV over 30-90 minutes on day 1 Treatment repeats every 21 days for 6 courses Beginning in course 7 patients receive placebo alone IV over 30-90 minutes on day 1 Treatment with placebo repeats every 21 days for up to 22 courses in the absence of disease progression or unacceptable toxicity
ARM II Patients receive paclitaxel and carboplatin as in arm I Beginning in course 2 patients also receive bevacizumab IV over 30-90 minutes on day 1 Treatment repeats every 21 days for 6 courses Beginning in course 7 patients receive placebo alone IV over 30-90 minutes on day 1 Treatment with placebo repeats every 21 days for up to 22 courses in the absence of disease progression or unacceptable toxicity
ARM III Patients receive paclitaxel and carboplatin as in arm I Beginning in course 2 patients also receive bevacizumab IV over 30-90 minutes on day 1 Treatment repeats every 21 days for 6 courses Beginning in course 7 patients receive bevacizumab alone IV over 30-90 minutes on day 1 Treatment with bevacizumab repeats every 21 days for up to 22 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every 3 months for 2 years every 6 months for 3 years and then annually 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 |
|---|---|---|---|
| U10CA027469 | NIH | CTEP | httpsreporternihgovquickSearchU10CA027469 |
| NCI-2009-00590 | REGISTRY | None | None |
| CDR0000455114 | None | None | None |
| GOG-0218 | OTHER | None | None |
| GOG-0218 | OTHER | None | None |
| U10CA180868 | NIH | None | None |