Ignite Creation Date:
2024-05-05 @ 4:44 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00303888
Status:
TERMINATED
Last Update Posted:
2018-01-17
First Post:
2006-03-15
Brief Title:
Docetaxel With or Without Phenoxodiol in Treating Patients With Recurrent Advanced Ovarian Epithelial Cancer Fallopian Tube Cancer or Primary Peritoneal Cavity Cancer
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
A Randomized Placebo-Controlled Phase IbIIa Safety Tolerability and Efficacy Study of Oral Phenoxodiol in Combination With Docetaxel Versus Docetaxel Alone in Patients With Recurrent Epithelial Ovarian Fallopian Tube and Primary Peritoneal Cancer
Status:
TERMINATED
Status Verified Date:
2018-01
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:
RATIONALE 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 Phenoxodiol may help docetaxel work better by making tumor cells more sensitive to the drug
PURPOSE This randomized phase III trial is studying the side effects of docetaxel when given together with either phenoxodiol or placebo and to see how well it works in treating patients with recurrent advanced ovarian epithelial cancer fallopian tube cancer or primary peritoneal cavity cancer
PURPOSE This randomized phase III trial is studying the side effects of docetaxel when given together with either phenoxodiol or placebo and to see how well it works in treating patients with recurrent advanced ovarian epithelial cancer fallopian tube cancer or primary peritoneal cavity cancer
Detailed Description:
OBJECTIVES
Primary
Determine the safety and tolerability of combination therapy comprising phenoxodiol and docetaxel in patients with recurrent or persistent advanced ovarian epithelial fallopian tube or primary peritoneal cavity cancer
Secondary
Determine the effect of phenoxodiol on the toxicity of docetaxel using a weekly treatment regimen
Determine if combination therapy comprising phenoxodiol and docetaxel is more efficacious than docetaxel therapy alone
Determine if combination therapy comprising phenoxodiol and docetaxel affects blood levels of either drug
Determine phenotypic differences in the tumor cells of responders and non-responders
OUTLINE This is a randomized placebo-controlled double-blind study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive docetaxel IV over 1 hour on days 1 8 and 15 and oral placebo three times daily on days 1-21
Arm II Patients receive oral phenoxodiol three times daily on days 1-21 and docetaxel as in arm I
Treatment in both arms repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed monthly for 6 months every 3 months for 1 year and then annually thereafter
PROJECTED ACCRUAL A total of 60 patients will be accrued for this study
3312017 NOTE
This study was terminated 102009 due to lack of enrollment The study never progressed to Phase 2
Primary
Determine the safety and tolerability of combination therapy comprising phenoxodiol and docetaxel in patients with recurrent or persistent advanced ovarian epithelial fallopian tube or primary peritoneal cavity cancer
Secondary
Determine the effect of phenoxodiol on the toxicity of docetaxel using a weekly treatment regimen
Determine if combination therapy comprising phenoxodiol and docetaxel is more efficacious than docetaxel therapy alone
Determine if combination therapy comprising phenoxodiol and docetaxel affects blood levels of either drug
Determine phenotypic differences in the tumor cells of responders and non-responders
OUTLINE This is a randomized placebo-controlled double-blind study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive docetaxel IV over 1 hour on days 1 8 and 15 and oral placebo three times daily on days 1-21
Arm II Patients receive oral phenoxodiol three times daily on days 1-21 and docetaxel as in arm I
Treatment in both arms repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed monthly for 6 months every 3 months for 1 year and then annually thereafter
PROJECTED ACCRUAL A total of 60 patients will be accrued for this study
3312017 NOTE
This study was terminated 102009 due to lack of enrollment The study never progressed to Phase 2
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| YALE-012705 | None | None | None |
| YALE-HIC-27640 | None | None | None |