Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00009815
Status:
WITHDRAWN
Last Update Posted:
2013-12-19
First Post:
2001-02-02
Brief Title:
Combination Chemotherapy in Treating Patients With Advanced Solid Tumors
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Phase I Study Of Oral Etoposide In Combination With ORZEL UFT Leucovorin For Advanced Non-Hematological Malignancies
Status:
WITHDRAWN
Status Verified Date:
2013-12
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 chemotherapy 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 etoposide when combined with fixed- dose fluorouracil-uracil plus leucovorin calcium in patients with advanced solid tumors II Determine possible side effects and toxicity of this regimen in these patients
OUTLINE This is a dose escalation study of etoposide Patients receive oral etoposide daily on days 1-10 and oral fluorouracil-uracil plus oral leucovorin calcium twice a day on days 1-21 Treatment repeats every 28 days for a maximum of 6 courses in the absence of unacceptable toxicity or disease progression Cohorts of 3-6 patients receive escalating doses of etoposide until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 or more of 6 patients experience dose-limiting toxicity Patients are followed at 2 months and then periodically for survival
PROJECTED ACCRUAL Approximately 25-30 patients will be accrued for this study
OUTLINE This is a dose escalation study of etoposide Patients receive oral etoposide daily on days 1-10 and oral fluorouracil-uracil plus oral leucovorin calcium twice a day on days 1-21 Treatment repeats every 28 days for a maximum of 6 courses in the absence of unacceptable toxicity or disease progression Cohorts of 3-6 patients receive escalating doses of etoposide until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 or more of 6 patients experience dose-limiting toxicity Patients are followed at 2 months and then periodically for survival
PROJECTED ACCRUAL Approximately 25-30 patients will be accrued for this study
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 |
|---|---|---|---|
| CDR0000068412 | REGISTRY | None | None |
| PCI-IRB-990923 | None | None | None |
| NCI-G00-1902 | Registry Identifier | PDQ Physician Data Query | None |