Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003956
Status:
COMPLETED
Last Update Posted:
2013-04-04
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy in Treating Patients With Advanced Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study of Continuous Oral Administration of SCH 66336 and 5-FluorouracilLeucovorin 5FULV in Patients With Advanced Cancer
Status:
COMPLETED
Status Verified Date:
2009-12
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 cancer cells from dividing so they stop growing or die Combining more than one drug may kill more cancer cells
PURPOSE Phase I trial to study the effectiveness of SCH 66336 fluorouracil and leucovorin in treating patients who have advanced cancer
PURPOSE Phase I trial to study the effectiveness of SCH 66336 fluorouracil and leucovorin in treating patients who have advanced cancer
Detailed Description:
OBJECTIVES I Determine the safety tolerability maximum tolerated dose and dose limiting toxicity of oral SCH 66336 with fluorouracil and leucovorin calcium in patients with advanced malignancy II Assess the multiple dose pharmacokinetics of oral SCH 66336 when administered with fluorouracil and leucovorin calcium III Assess the pharmacokinetics of fluorouracil when administered with oral SCH 66336 IV Assess antitumor activity of oral SCH 66336 with fluorouracil and leucovorin calcium in these patients
OUTLINE This is a dose escalation study of SCH 66336 Patients receive oral SCH 66336 twice daily for 56 days Patients receive leucovorin calcium IV over 1-2 minutes immediately followed by fluorouracil IV over 1-2 minutes on days 1 8 15 22 29 and 36 Courses repeat every 56 days in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of SCH 66336 The maximum tolerated dose is defined as the dose at which no more than 1 of 6 patients experiences dose limiting toxicity DLT during course 1 with at least 2 patients experiencing DLT at the next higher level
PROJECTED ACCRUAL Approximately 25 patients will be accrued for this study
OUTLINE This is a dose escalation study of SCH 66336 Patients receive oral SCH 66336 twice daily for 56 days Patients receive leucovorin calcium IV over 1-2 minutes immediately followed by fluorouracil IV over 1-2 minutes on days 1 8 15 22 29 and 36 Courses repeat every 56 days in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of SCH 66336 The maximum tolerated dose is defined as the dose at which no more than 1 of 6 patients experiences dose limiting toxicity DLT during course 1 with at least 2 patients experiencing DLT at the next higher level
PROJECTED ACCRUAL Approximately 25 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 |
|---|---|---|---|
| NCI-G99-1540 | None | None | None |
| MSKCC-99020 | None | None | None |
| SPRI-C98-564-01 | None | None | None |