Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004082
Status:
COMPLETED
Last Update Posted:
2013-06-26
First Post:
1999-12-10
Brief Title:
Combination Chemotherapy in Treating Patients With Previously Untreated Newly Diagnosed Epithelial Tumors
Sponsor:
Beth Israel Deaconess Medical Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study of Docetaxel Taxotere Carboplatin and Gemcitabine DoCaGem as First-Line Therapy for Patients With High-Risk Epithelial Tumors of Mullerian Origin
Status:
COMPLETED
Status Verified Date:
2010-11
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 use different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug may kill more tumor cells
PURPOSE Phase I trial to study the effectiveness of combining docetaxel carboplatin and gemcitabine in treating patients who have previously untreated newly diagnosed epithelial cancer
PURPOSE Phase I trial to study the effectiveness of combining docetaxel carboplatin and gemcitabine in treating patients who have previously untreated newly diagnosed epithelial cancer
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose of docetaxel carboplatin and gemcitabine in patients with previously untreated newly diagnosed high-risk epithelial cancer of mullerian origin
OUTLINE This is a dose-escalation study of docetaxel and gemcitabine Patients receive docetaxel IV over 30 minutes and gemcitabine IV over 30 minutes on days 1 and 8 Carboplatin IV is administered over 30 minutes on day 1 Treatment repeats every 21-28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity Cohorts of 3-5 patients receive escalating doses of docetaxel and gemcitabine until the maximum tolerated dose is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 5 patients experience dose-limiting toxicity
PROJECTED ACCRUAL A total of 20-30 patients will be accrued for this study within 15-2 years
OUTLINE This is a dose-escalation study of docetaxel and gemcitabine Patients receive docetaxel IV over 30 minutes and gemcitabine IV over 30 minutes on days 1 and 8 Carboplatin IV is administered over 30 minutes on day 1 Treatment repeats every 21-28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity Cohorts of 3-5 patients receive escalating doses of docetaxel and gemcitabine until the maximum tolerated dose is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 5 patients experience dose-limiting toxicity
PROJECTED ACCRUAL A total of 20-30 patients will be accrued for this study within 15-2 years
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 |
|---|---|---|---|
| NCI-V99-1566 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000067293 | REGISTRY | None | None |