Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00019019
Status:
COMPLETED
Last Update Posted:
2012-03-15
First Post:
2001-07-11
Brief Title:
Carboxyamidotriazole and Paclitaxel in Treating Patients With Advanced Solid Tumors or Refractory Lymphomas
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A PHASE I STUDY OF THE COMBINATION OF CAI AND PACLITAXEL IN ADULT PATIENTS WITH REFRACTORY CANCERS OR LYMPHOMA
Status:
COMPLETED
Status Verified Date:
2012-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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 This phase I trial is studying the side effects and best dose of carboxyamidotriazole and paclitaxel in treating patients with advanced solid tumors or refractory lymphomas
PURPOSE This phase I trial is studying the side effects and best dose of carboxyamidotriazole and paclitaxel in treating patients with advanced solid tumors or refractory lymphomas
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of paclitaxel when combined with carboxyamidotriazole in patients with advanced solid tumors or refractory lymphomas
Determine the pharmacokinetics and toxicities of this regimen in these patients
Identify diseases for which this combination appears active
OUTLINE This is a dose escalation study
Patients receive oral carboxyamidotriazole CAI daily with paclitaxel IV over 3 hours on day 8 and every 3 weeks thereafter Course 1 is 28 days and all other subsequent courses are 21 days Treatment continues in the absence of disease progression or unacceptable toxicity Patients who achieve complete response receive 2 additional courses of treatment
Sequential dose escalation of CAI is followed by sequential dose escalation of paclitaxel Dose escalation in cohorts of 3 to 6 patients each continues until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity
PROJECTED ACCRUAL A total of 70 patients will be accrued for this study
Determine the maximum tolerated dose of paclitaxel when combined with carboxyamidotriazole in patients with advanced solid tumors or refractory lymphomas
Determine the pharmacokinetics and toxicities of this regimen in these patients
Identify diseases for which this combination appears active
OUTLINE This is a dose escalation study
Patients receive oral carboxyamidotriazole CAI daily with paclitaxel IV over 3 hours on day 8 and every 3 weeks thereafter Course 1 is 28 days and all other subsequent courses are 21 days Treatment continues in the absence of disease progression or unacceptable toxicity Patients who achieve complete response receive 2 additional courses of treatment
Sequential dose escalation of CAI is followed by sequential dose escalation of paclitaxel Dose escalation in cohorts of 3 to 6 patients each continues until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity
PROJECTED ACCRUAL A total of 70 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 |
|---|---|---|---|
| CDR0000063881 | None | None | None |
| 95-C-0015 | None | None | None |
| NCI-CPB-334 | None | None | None |
| NCI-T94-0006N | None | None | None |