Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00084890
Status:
TERMINATED
Last Update Posted:
2018-08-10
First Post:
2004-06-10
Brief Title:
Docetaxel and Carboplatin in Treating Patients With Recurrent Stage IVB Squamous Cell Carcinoma Cancer of the Cervix
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
Weekly Docetaxel and Carboplatin in Patients With Recurrent Squamous Carcinoma of the Cervix A Phase III Study
Status:
TERMINATED
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
slow accrual
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 tumor cells from dividing so they stop growing or die Combining docetaxel with carboplatin may kill more tumor cells
PURPOSE This phase III trial is studying the side effects and best dose of docetaxel when given together with carboplatin and to see how well they work in treating patients with recurrent stage IVB squamous cell carcinoma cancer of the cervix
PURPOSE This phase III trial is studying the side effects and best dose of docetaxel when given together with carboplatin and to see how well they work in treating patients with recurrent stage IVB squamous cell carcinoma cancer of the cervix
Detailed Description:
OBJECTIVES
Primary
Determine the maximum tolerated dose of docetaxel when administered with carboplatin in patients with recurrent stage IVB squamous cell carcinoma of the cervix
Determine the response rate and time to progression in patients treated with this regimen
Secondary
Determine the toxicity of this regimen in these patients
Determine the quality of life of patients treated with this regimen
OUTLINE This is phase I dose-escalation study of docetaxel followed by a phase II study
Phase I Patients receive docetaxel IV over 30 minutes and carboplatin IV over 30 minutes on days 1 8 and 15 Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity Patients who demonstrate continuing tumor shrinkage after 6 courses receive 2 additional courses beyond their best response
Cohorts of 3-6 patients receive escalating doses of docetaxel until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Phase II Patients receive docetaxel and carboplatin as in phase I at the MTD determined in phase I
Quality of life is assessed at baseline before every other course of treatment and at the end of study treatment
Patients are followed every 2 months
PROJECTED ACCRUAL A total of 3-64 patients 3-24 for phase I and 16-40 for phase II will be accrued for this study within 2 years
Primary
Determine the maximum tolerated dose of docetaxel when administered with carboplatin in patients with recurrent stage IVB squamous cell carcinoma of the cervix
Determine the response rate and time to progression in patients treated with this regimen
Secondary
Determine the toxicity of this regimen in these patients
Determine the quality of life of patients treated with this regimen
OUTLINE This is phase I dose-escalation study of docetaxel followed by a phase II study
Phase I Patients receive docetaxel IV over 30 minutes and carboplatin IV over 30 minutes on days 1 8 and 15 Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity Patients who demonstrate continuing tumor shrinkage after 6 courses receive 2 additional courses beyond their best response
Cohorts of 3-6 patients receive escalating doses of docetaxel until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Phase II Patients receive docetaxel and carboplatin as in phase I at the MTD determined in phase I
Quality of life is assessed at baseline before every other course of treatment and at the end of study treatment
Patients are followed every 2 months
PROJECTED ACCRUAL A total of 3-64 patients 3-24 for phase I and 16-40 for phase II will be accrued for this study within 2 years
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 |
|---|---|---|---|
| NCI-6949 | None | None | None |
| CCCWFU-30102B | None | None | None |