Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00041080
Status:
COMPLETED
Last Update Posted:
2019-07-30
First Post:
2002-07-08
Brief Title:
Tamoxifen Compared With Thalidomide in Treating Women With Ovarian Epithelial Cancer Fallopian Tube Cancer or Primary Peritoneal Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Randomized Study Of Tamoxifen Versus Thalidomide NSC 66847 In Patients With Biochemical-Recurrence-Only Epithelial Ovarian Cancer Cancer Of The Fallopian Tube And Primary Peritoneal Carcinoma After First Line Chemotherapy
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:
Randomized phase III trial to compare the effectiveness of tamoxifen with that of thalidomide in treating women who have recurrent ovarian epithelial cancer fallopian tube cancer or primary peritoneal cancer Estrogen can stimulate the growth of some types of cancer cells Hormone therapy using tamoxifen may fight cancer by blocking the uptake of estrogen Thalidomide may stop the growth of cancer by stopping blood flow to the tumor It is not yet known whether thalidomide is more effective than tamoxifen in treating ovarian epithelial cancer fallopian tube cancer or primary peritoneal cancer
Detailed Description:
PRIMARY OBJECTIVES
I To compare the recurrence-free survival of women receiving tamoxifen or thalidomide for epithelial ovarian cancer cancer of the fallopian tube or primary peritoneal carcinoma who are in complete clinical remission following front-line treatment but have a high risk of recurrence due to rising serum CA-125
II To compare the toxicities and complications of these treatments
SECONDARY OBJECTIVES
I To determine whether changes in serum biomarker levels including VEGF andor bFGF are independent of the randomization treatment
II To determine whether serum and plasma biomarker levels including VEGF andor bFGF are associated with the duration of recurrence-free survival
OUTLINE This is a randomized multicenter study Patients are stratified according to the interval between completion of front-line chemotherapy and appearance of biochemical progression 6 months or less vs more than 6 months Patients are randomized to 1 of 2 treatment arms
ARM I Patients receive oral thalidomide once daily on days 1-28
ARM II Patients receive oral tamoxifen twice daily on days 1-28
In both arms courses repeat every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity Patients may receive additional therapy beyond 1 year at the investigators discretion
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
I To compare the recurrence-free survival of women receiving tamoxifen or thalidomide for epithelial ovarian cancer cancer of the fallopian tube or primary peritoneal carcinoma who are in complete clinical remission following front-line treatment but have a high risk of recurrence due to rising serum CA-125
II To compare the toxicities and complications of these treatments
SECONDARY OBJECTIVES
I To determine whether changes in serum biomarker levels including VEGF andor bFGF are independent of the randomization treatment
II To determine whether serum and plasma biomarker levels including VEGF andor bFGF are associated with the duration of recurrence-free survival
OUTLINE This is a randomized multicenter study Patients are stratified according to the interval between completion of front-line chemotherapy and appearance of biochemical progression 6 months or less vs more than 6 months Patients are randomized to 1 of 2 treatment arms
ARM I Patients receive oral thalidomide once daily on days 1-28
ARM II Patients receive oral tamoxifen twice daily on days 1-28
In both arms courses repeat every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity Patients may receive additional therapy beyond 1 year at the investigators discretion
Patients are followed 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-2012-02475 | REGISTRY | None | None |
| CDR0000069441 | None | None | None |
| GOG-0198 | OTHER | None | None |
| GOG-0198 | OTHER | None | None |