Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004913
Status:
COMPLETED
Last Update Posted:
2012-06-01
First Post:
2000-03-07
Brief Title:
Combination Chemotherapy in Treating Patients With Advanced Solid Tumors
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
A Phase I Study of Docetaxel Plus 5-FU Cisplatin and Leucovorin in Patients With Advanced Solid Tumors
Status:
COMPLETED
Status Verified Date:
2012-05
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 combination chemotherapy in treating patients who have advanced solid tumors
PURPOSE Phase I trial to study the effectiveness of combination chemotherapy in treating patients who have advanced solid tumors
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose of docetaxel administered in combination with cisplatin fluorouracil and leucovorin calcium in patients with advanced solid tumors II Determine the toxicities associated with this combination regimen in this patient population III Evaluate the clinical response to this combination regimen in these patients
OUTLINE This is a dose escalation study of docetaxel and fluorouracil 5-FU Patients receive docetaxel IV over 1 hour on day 1 cisplatin IV over 1 hour on day 2 and leucovorin calcium IV immediately followed by 5-FU IV on days 1-5 Treatment repeats every 3 weeks in the absence of disease progression Cohorts of 3-5 patients receive escalating doses of docetaxel and 5-FU until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which more than 1 of 3 or 1 of 5 patients experience dose limiting toxicity Patients are followed every 3 months until death
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study over 2 years
OUTLINE This is a dose escalation study of docetaxel and fluorouracil 5-FU Patients receive docetaxel IV over 1 hour on day 1 cisplatin IV over 1 hour on day 2 and leucovorin calcium IV immediately followed by 5-FU IV on days 1-5 Treatment repeats every 3 weeks in the absence of disease progression Cohorts of 3-5 patients receive escalating doses of docetaxel and 5-FU until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which more than 1 of 3 or 1 of 5 patients experience dose limiting toxicity Patients are followed every 3 months until death
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study over 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-G00-1707 | None | None | None |
| NU-98X2 | None | None | None |