Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00024310
Status:
UNKNOWN
Last Update Posted:
2013-09-17
First Post:
2001-09-13
Brief Title:
Paclitaxel Folic Acid and Lometrexol in Treating Patients With Locally Advanced or Metastatic Solid Tumors
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Trial of Lometrexol Sodium and Paclitaxel Adminsitered Intravenously Every 21 Days in Conjunction With Oral Folic Acid in Patients With Solid Tumors
Status:
UNKNOWN
Status Verified Date:
2002-11
Last Known Status:
ACTIVE_NOT_RECRUITING
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 Folic acid may protect normal cells from the side effects of chemotherapy and may increase the effectiveness of chemotherapy by making tumor cells more sensitive to the drug Lometrexol may stop the growth of tumors by blocking one of the enzymes necessary for cancer cell growth Combining chemotherapy with folic acid and lometrexol may kill more tumor cells
PURPOSE Phase I trial to study the effectiveness of combining paclitaxel folic acid and lometrexol in treating patients who have locally advanced or metastatic solid tumors
PURPOSE Phase I trial to study the effectiveness of combining paclitaxel folic acid and lometrexol in treating patients who have locally advanced or metastatic solid tumors
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose and recommended phase II study dose of lometrexol and paclitaxel when combined with folic acid in patients with locally advanced or metastatic solid tumors
Determine the quantitative and qualitative toxic effects of this regimen in these patients
Determine the plasma concentrations of lometrexol and paclitaxel and relate their pharmacokinetics to toxicity outcome in these patients
Determine the antitumor activity of this regimen in these patients
OUTLINE This is a multicenter dose-escalation study of lometrexol and paclitaxel
Patients receive lometrexol IV over 30-60 seconds immediately followed by paclitaxel IV over 3 hours on day 1 Patients also receive oral folic acid beginning 7 days before lometrexolpaclitaxel and continuing for 14 days Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity
Doses of lometrexol and paclitaxel are escalated sequentially Cohorts of 3-6 patients receive escalating doses of lometrexol and paclitaxel until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which at least 2 of 6 patients experience dose-limiting toxicity Six to twelve additional patients are treated at the recommended phase II study dose dose immediately preceding the MTD
Patients are followed every 3 months
PROJECTED ACCRUAL Approximately 12-42 patients will be accrued for this study
Determine the maximum tolerated dose and recommended phase II study dose of lometrexol and paclitaxel when combined with folic acid in patients with locally advanced or metastatic solid tumors
Determine the quantitative and qualitative toxic effects of this regimen in these patients
Determine the plasma concentrations of lometrexol and paclitaxel and relate their pharmacokinetics to toxicity outcome in these patients
Determine the antitumor activity of this regimen in these patients
OUTLINE This is a multicenter dose-escalation study of lometrexol and paclitaxel
Patients receive lometrexol IV over 30-60 seconds immediately followed by paclitaxel IV over 3 hours on day 1 Patients also receive oral folic acid beginning 7 days before lometrexolpaclitaxel and continuing for 14 days Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity
Doses of lometrexol and paclitaxel are escalated sequentially Cohorts of 3-6 patients receive escalating doses of lometrexol and paclitaxel until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which at least 2 of 6 patients experience dose-limiting toxicity Six to twelve additional patients are treated at the recommended phase II study dose dose immediately preceding the MTD
Patients are followed every 3 months
PROJECTED ACCRUAL Approximately 12-42 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 |
|---|---|---|---|
| UCLA-0005068 | None | None | None |
| TULA-T3004 | None | None | None |
| NCI-G01-2017 | None | None | None |