Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00138242
Status:
COMPLETED
Last Update Posted:
2013-06-26
First Post:
2005-08-29
Brief Title:
Docetaxel and Carboplatin in Treating Patients With Ovarian Epithelial Fallopian Tube or Peritoneal Cavity Cancer
Sponsor:
Floyd Delores Jones Cancer Institute at Virginia Mason Medical Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Trial of Weekly Docetaxel Taxotere and Carboplatin as Initial Chemotherapy for Women With Ovarian Cancer and Similar Malignancies
Status:
COMPLETED
Status Verified Date:
2006-10
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 and carboplatin 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 docetaxel together with carboplatin works in treating patients with ovarian epithelial fallopian tube or peritoneal cavity cancer
PURPOSE This phase II trial is studying how well giving docetaxel together with carboplatin works in treating patients with ovarian epithelial fallopian tube or peritoneal cavity cancer
Detailed Description:
OBJECTIVES
Primary
Determine whether weekly administration of docetaxel and carboplatin is safer than conventional three-week chemotherapy courses in terms of reducing the rate of myelosuppression in patients with stage IC-IV ovarian epithelial fallopian tube or peritoneal cavity cancer
Secondary
Determine the quality of life of patients treated with this regimen
Determine the toxic effects of this regimen in these patients
Determine the efficacy of this regimen in terms of clinical response rate time to disease progression and findings at second-look surgery in these patients
OUTLINE Patients receive docetaxel IV and carboplatin IV on days 1 8 15 Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity Patients may then undergo optional second-look surgery After completion of 6 courses of chemotherapy and second-look surgery if applicable patients may receive consolidation andor salvage therapy at the discretion of the investigator
Quality of life is assessed at baseline before each treatment course at the completion of study treatment and then annually for 2 years
After completion of study treatment patients are followed annually for 2 years
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study within 2 years
Primary
Determine whether weekly administration of docetaxel and carboplatin is safer than conventional three-week chemotherapy courses in terms of reducing the rate of myelosuppression in patients with stage IC-IV ovarian epithelial fallopian tube or peritoneal cavity cancer
Secondary
Determine the quality of life of patients treated with this regimen
Determine the toxic effects of this regimen in these patients
Determine the efficacy of this regimen in terms of clinical response rate time to disease progression and findings at second-look surgery in these patients
OUTLINE Patients receive docetaxel IV and carboplatin IV on days 1 8 15 Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity Patients may then undergo optional second-look surgery After completion of 6 courses of chemotherapy and second-look surgery if applicable patients may receive consolidation andor salvage therapy at the discretion of the investigator
Quality of life is assessed at baseline before each treatment course at the completion of study treatment and then annually for 2 years
After completion of study treatment patients are followed annually for 2 years
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study within 2 years
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 |
|---|---|---|---|
| AVENTIS-VMRC-8837 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000439927 | REGISTRY | None | None |