Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00354601
Status:
TERMINATED
Last Update Posted:
2017-08-30
First Post:
2006-07-19
Brief Title:
Docetaxel and Capecitabine in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer Fallopian Tube Cancer or Peritoneal Cavity Cancer
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
A Phase II Study of Weekly Docetaxel and Capecitabine for Persistent or Recurrent Platinum Resistant Epithelial Carcinoma of the Ovary Fallopian Tube or Peritoneum
Status:
TERMINATED
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
funding withdrawn
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 and capecitabine work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving docetaxel together with carboplatin may kill more tumor cells
PURPOSE This phase II trial is studying how well giving docetaxel together with capecitabine works in treating patients with recurrent or persistent ovarian epithelial cancer fallopian tube cancer or peritoneal cavity cancer
PURPOSE This phase II trial is studying how well giving docetaxel together with capecitabine works in treating patients with recurrent or persistent ovarian epithelial cancer fallopian tube cancer or peritoneal cavity cancer
Detailed Description:
OBJECTIVES
Primary
Determine the response rate in patients with recurrent or persistent ovarian epithelial cancer fallopian tube cancer or peritoneal cavity cancer treated with docetaxel and capecitabine
Secondary
Determine the time to progression in patients treated with this regimen
Determine the toxicity of this regimen in these patients
Determine the quality of life during treatment of these patients
OUTLINE Patients receive docetaxel IV over 30 minutes on days 1 8 and 15 and oral capecitabine twice daily on days 1-21 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline on day 1 of each course and then at completion of study treatment
After completion of study treatment patients are followed every 2-3 months
Primary
Determine the response rate in patients with recurrent or persistent ovarian epithelial cancer fallopian tube cancer or peritoneal cavity cancer treated with docetaxel and capecitabine
Secondary
Determine the time to progression in patients treated with this regimen
Determine the toxicity of this regimen in these patients
Determine the quality of life during treatment of these patients
OUTLINE Patients receive docetaxel IV over 30 minutes on days 1 8 and 15 and oral capecitabine twice daily on days 1-21 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline on day 1 of each course and then at completion of study treatment
After completion of study treatment patients are followed every 2-3 months
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 |
|---|---|---|---|
| ROCHE-CCCWFU-BG05-536 | None | None | None |
| CCCWFU-83203 | None | None | None |
| CCCWFU-BG05-536 | None | None | None |
| AVENTIS-CCCWFU-83203 | None | None | None |
| CDR0000489036 | None | None | None |