Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00227721
Status:
COMPLETED
Last Update Posted:
2020-12-02
First Post:
2005-09-26
Brief Title:
Gemcitabine and Docetaxel in Treating Patients With Relapsed or Refractory Ovarian Epithelial or Peritoneal Cancer
Sponsor:
Robert Morris
Organization:
Barbara Ann Karmanos Cancer Institute
Study Overview
Official Title:
Phase II Trial of Weekly Gemcitabine and Docetaxel Combination Therapy for Relapsed Ovarian or Peritoneal Cancer
Status:
COMPLETED
Status Verified Date:
2020-11
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 gemcitabine and docetaxel work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving more than one drug combination chemotherapy may kill more tumor cells
PURPOSE This phase II trial is studying how well giving gemcitabine together with docetaxel works in treating patients with relapsed or refractory ovarian epithelial or peritoneal cancer
PURPOSE This phase II trial is studying how well giving gemcitabine together with docetaxel works in treating patients with relapsed or refractory ovarian epithelial or peritoneal cancer
Detailed Description:
OBJECTIVES
Primary
Determine the response rate in patients with platinum-sensitive or -resistant relapsed or refractory ovarian epithelial or peritoneal cavity cancer treated with gemcitabine and docetaxel
Secondary
Determine the toxicity of this regimen in these patients
Determine the overall survival of patients treated with this regimen
Determine the time to treatment failure and progression-free survival of patients treated with this regimen
OUTLINE This is a multicenter study Patients are stratified according to response to prior treatment with a platinum-containing regimen platinum-resistant disease vs platinum-sensitive disease
Patients receive gemcitabine IV over 30 minutes and docetaxel IV over 30 minutes on days 1 and 8 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity Patients achieving a complete response CR receive 3 additional courses beyond CR 6 total courses of treatment
PROJECTED ACCRUAL Approximately 36-62 patients 19-29 for stratum I platinum-resistant disease and 17-33 for stratum II platinum-sensitive disease will be accrued for this study
Primary
Determine the response rate in patients with platinum-sensitive or -resistant relapsed or refractory ovarian epithelial or peritoneal cavity cancer treated with gemcitabine and docetaxel
Secondary
Determine the toxicity of this regimen in these patients
Determine the overall survival of patients treated with this regimen
Determine the time to treatment failure and progression-free survival of patients treated with this regimen
OUTLINE This is a multicenter study Patients are stratified according to response to prior treatment with a platinum-containing regimen platinum-resistant disease vs platinum-sensitive disease
Patients receive gemcitabine IV over 30 minutes and docetaxel IV over 30 minutes on days 1 and 8 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity Patients achieving a complete response CR receive 3 additional courses beyond CR 6 total courses of treatment
PROJECTED ACCRUAL Approximately 36-62 patients 19-29 for stratum I platinum-resistant disease and 17-33 for stratum II platinum-sensitive disease 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 |
|---|---|---|---|
| WSU-C-2713 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA022453 |
| P30CA022453 | NIH | None | None |