Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004057
Status:
COMPLETED
Last Update Posted:
2013-06-21
First Post:
1999-12-10
Brief Title:
Paclitaxel Plus L-778123 in Treating Patients With Recurrent or Refractory Solid Tumors or Lymphomas
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
A Phase I and Pharmacokinetic Study Evaluating the Safety Tolerability and Maximally Tolerated Dose of Combination Therapy With Paclitaxel and L-778123 in Patients With Recurrent or Refractory Solid Malignancies
Status:
COMPLETED
Status Verified Date:
2013-06
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 combining paclitaxel and L-778123 in treating patients who have recurrent or refractory solid tumors or lymphomas
PURPOSE Phase I trial to study the effectiveness of combining paclitaxel and L-778123 in treating patients who have recurrent or refractory solid tumors or lymphomas
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose of L-778123 when combined with paclitaxel in patients with recurrent or refractory solid tumors or lymphomas II Evaluate the safety tolerability and dose limiting toxicity of this regimen in these patients III Assess steady state plasma concentrations of various doses of L-778123 combined with paclitaxel in these patients IV Evaluate radiologic or tumor marker responses to this regimen in these patients V Evaluate the relationship between ras mutations and response to this regimen in these patients
OUTLINE This is a dose escalation multicenter study of L-778123 Patients receive paclitaxel IV over 3 hours followed within 24 hours by L-778123 IV over 7 days Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity Patients achieving complete response receive 2 courses after documentation of response Cohorts of 1-3 patients receive escalating doses of L-778123 until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which 2 of 6 patients experience dose limiting toxicity Patients are followed at about 2 weeks
PROJECTED ACCRUAL A maximum of 40 patients will be accrued for this study
OUTLINE This is a dose escalation multicenter study of L-778123 Patients receive paclitaxel IV over 3 hours followed within 24 hours by L-778123 IV over 7 days Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity Patients achieving complete response receive 2 courses after documentation of response Cohorts of 1-3 patients receive escalating doses of L-778123 until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which 2 of 6 patients experience dose limiting toxicity Patients are followed at about 2 weeks
PROJECTED ACCRUAL A maximum of 40 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-G99-1572 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000067254 | REGISTRY | None | None |
| MERCK-003-04 | None | None | None |