Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00091377
Status:
COMPLETED
Last Update Posted:
2016-07-14
First Post:
2004-09-07
Brief Title:
Phenoxodiol Combined With Either Cisplatin or Paclitaxel in Patients With Recurrent Ovarian Epithelial Fallopian Tube or Primary Peritoneal Cancer
Sponsor:
MEI Pharma Inc
Organization:
MEI Pharma Inc
Study Overview
Official Title:
Multi-Center Phase IbIIa Safety and Preliminary Efficacy Study of Phenoxodiol Intravenous as a Chemo-Sensitizing Agent for Cisplatin and Paclitaxel in Epithelial Ovarian Cancer or Primary Peritoneal Cancer Platinum- andor Taxane-Refractory or Resistant
Status:
COMPLETED
Status Verified Date:
2016-07
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:
RATIONALE Drugs used in chemotherapy such as cisplatin and paclitaxel work in different ways to stop tumor cells from dividing so they stop growing or die Phenoxodiol may help cisplatin and paclitaxel kill more tumor cells by making tumor cells more sensitive to the drugs
PURPOSE This randomized phase III trial is studying the side effects of phenoxodiol when given together with either cisplatin or paclitaxel and to see how well they work in treating patients with recurrent late-stage ovarian epithelial cancer fallopian tube cancer or primary peritoneal cancer that has not responded to treatment with drugs such as paclitaxel docetaxel cisplatin or carboplatin
PURPOSE This randomized phase III trial is studying the side effects of phenoxodiol when given together with either cisplatin or paclitaxel and to see how well they work in treating patients with recurrent late-stage ovarian epithelial cancer fallopian tube cancer or primary peritoneal cancer that has not responded to treatment with drugs such as paclitaxel docetaxel cisplatin or carboplatin
Detailed Description:
OBJECTIVES
Primary
Compare the safety and tolerability of phenoxodiol combined with cisplatin or paclitaxel in patients with recurrent late-stage ovarian epithelial fallopian tube or primary peritoneal cancer that is refractory or resistant to platinum andor taxane drugs
Compare preliminarily tumor response in patients treated with these regimens
OUTLINE This is an open-label randomized multicenter study Patients are randomized to 1 of 2 treatment arms according to medical history
Arm I Patients receive phenoxodiol IV over 10 minutes on days 1 and 2 and cisplatin IV over 1 hour on day 2
Arm II Patients receive phenoxodiol as in arm I and paclitaxel IV over 1 hour on day 2
In both arms treatment repeats every 6 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at 12 24 36 and 48 weeks or at the end of study participation
Patients are followed at 6 and 12 months
PROJECTED ACCRUAL A total of 40 patients 20 per treatment arm will be accrued for this study
Primary
Compare the safety and tolerability of phenoxodiol combined with cisplatin or paclitaxel in patients with recurrent late-stage ovarian epithelial fallopian tube or primary peritoneal cancer that is refractory or resistant to platinum andor taxane drugs
Compare preliminarily tumor response in patients treated with these regimens
OUTLINE This is an open-label randomized multicenter study Patients are randomized to 1 of 2 treatment arms according to medical history
Arm I Patients receive phenoxodiol IV over 10 minutes on days 1 and 2 and cisplatin IV over 1 hour on day 2
Arm II Patients receive phenoxodiol as in arm I and paclitaxel IV over 1 hour on day 2
In both arms treatment repeats every 6 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at 12 24 36 and 48 weeks or at the end of study participation
Patients are followed at 6 and 12 months
PROJECTED ACCRUAL A total of 40 patients 20 per treatment arm will be accrued for this study
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 |
|---|---|---|---|
| YALE-HIC-26423 | None | None | None |
| NOVOGEN-NV06-037 | None | None | None |