Ignite Creation Date:
2024-05-05 @ 4:45 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00305838
Status:
UNKNOWN
Last Update Posted:
2013-08-12
First Post:
2006-03-21
Brief Title:
CA 125 Levels in Treating Patients With Relapsed Advanced Ovarian Cancer Fallopian Tube Cancer or Primary Peritoneal Cancer Who Are Receiving Tamoxifen
Sponsor:
Mount Vernon Cancer Centre at Mount Vernon Hospital
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Use of Changes in CA 125 Doubling Time to Detect Activity of Cytostatic Agents in Women Relapsing With Ovarian Carcinoma Study 1-Tamoxifen
Status:
UNKNOWN
Status Verified Date:
2009-06
Last Known Status:
RECRUITING
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:
RATIONALE Estrogen may cause the growth of ovarian cancer cells Hormone therapy using tamoxifen may fight ovarian cancer by blocking the use of estrogen by the tumor cells Measuring CA 125 levels may help doctors predict a patients response to tamoxifen and help plan the best treatment
PURPOSE This phase II trial is studying CA 125 levels in treating patients with relapsed advanced ovarian cancer fallopian tube cancer or primary peritoneal cancer who are receiving tamoxifen
PURPOSE This phase II trial is studying CA 125 levels in treating patients with relapsed advanced ovarian cancer fallopian tube cancer or primary peritoneal cancer who are receiving tamoxifen
Detailed Description:
OBJECTIVES
Determine the percentage of patients with relapsed advanced ovarian carcinoma fallopian tube carcinoma or primary peritoneal carcinoma who have a log linear rise in CA 125 levels
Determine whether the log linear part of the curve is consistent enough to allow comparison of the slope before and after introduction of a new therapy
Compare the serial doubling time before and after commencing tamoxifen citrate treatment
Determine the number of patients required to detect a significant difference in CA 125 doubling time before and after starting tamoxifen citrate treatment
OUTLINE Patients undergo blood collection once a month to measure CA 125 levels Once the CA 125 level goes above the upper limit of normal ULN or has started to rise from its nadir level if not previously normal CA 125 levels are measured every 2 weeks When CA 125 levels reach 4 times the ULN or 4 times the nadir level if not previously normal patients begin oral tamoxifen citrate once daily for 3-6 months in the absence of disease progression or unacceptable toxicity CA 125 levels will continue to be measured every 2 weeks during treatment
PROJECTED ACCRUAL A total of 200 patients will be accrued for this study
Determine the percentage of patients with relapsed advanced ovarian carcinoma fallopian tube carcinoma or primary peritoneal carcinoma who have a log linear rise in CA 125 levels
Determine whether the log linear part of the curve is consistent enough to allow comparison of the slope before and after introduction of a new therapy
Compare the serial doubling time before and after commencing tamoxifen citrate treatment
Determine the number of patients required to detect a significant difference in CA 125 doubling time before and after starting tamoxifen citrate treatment
OUTLINE Patients undergo blood collection once a month to measure CA 125 levels Once the CA 125 level goes above the upper limit of normal ULN or has started to rise from its nadir level if not previously normal CA 125 levels are measured every 2 weeks When CA 125 levels reach 4 times the ULN or 4 times the nadir level if not previously normal patients begin oral tamoxifen citrate once daily for 3-6 months in the absence of disease progression or unacceptable toxicity CA 125 levels will continue to be measured every 2 weeks during treatment
PROJECTED ACCRUAL A total of 200 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MREC-EC2003-62 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000463518 | REGISTRY | None | None |
| EU-205113 | None | None | None |
| NCRN-1509 | None | None | None |