Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00081042
Status:
COMPLETED
Last Update Posted:
2013-12-19
First Post:
2004-04-07
Brief Title:
ABI-007 in Treating Patients With Inoperable Locally Recurrent or Metastatic Melanoma
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
An Open-Label Multicenter Phase II Trial of ABI-007 A Cremophor -Free Protein Stabilized Nanoparticle Paclitaxel in Previously Treated Patients With Metastatic Melanoma
Status:
COMPLETED
Status Verified Date:
2005-05
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 such as ABI-007 work in different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE This phase II trial is studying how well ABI-007 works in treating patients with inoperable unresectable locally recurrent or metastatic melanoma
PURPOSE This phase II trial is studying how well ABI-007 works in treating patients with inoperable unresectable locally recurrent or metastatic melanoma
Detailed Description:
OBJECTIVES
Primary
Determine the antitumor activity of ABI-007 in patients with inoperable locally recurrent or metastatic melanoma
Determine the safety and tolerability of this drug in these patients
Secondary
Determine the time to disease progression in terms of the rate and duration of response or stable disease in patients treated with this drug
Determine the survival of patients treated with this drug
Determine the effects of this drug on biomarkers of melanoma in these patients
Correlate biomarker levels with response in patients treated with this drug
OUTLINE This is an open-label multicenter study Patients are assigned to 1 of 2 treatment cohorts according to prior cytotoxic chemotherapy previously treated vs chemotherapy-naïve
Cohort I previously treated Patients receive ABI-007 IV over 30 minutes on days 1 8 and 15
Cohort II chemotherapy-naïve Patients receive a higher dose of ABI-007 as in cohort I
In both cohorts courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity
Patients are followed monthly for 6 months and then every 3 months thereafter
PROJECTED ACCRUAL A total of 24-70 patients 12-35 per cohort will be accrued for this study
Primary
Determine the antitumor activity of ABI-007 in patients with inoperable locally recurrent or metastatic melanoma
Determine the safety and tolerability of this drug in these patients
Secondary
Determine the time to disease progression in terms of the rate and duration of response or stable disease in patients treated with this drug
Determine the survival of patients treated with this drug
Determine the effects of this drug on biomarkers of melanoma in these patients
Correlate biomarker levels with response in patients treated with this drug
OUTLINE This is an open-label multicenter study Patients are assigned to 1 of 2 treatment cohorts according to prior cytotoxic chemotherapy previously treated vs chemotherapy-naïve
Cohort I previously treated Patients receive ABI-007 IV over 30 minutes on days 1 8 and 15
Cohort II chemotherapy-naïve Patients receive a higher dose of ABI-007 as in cohort I
In both cohorts courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity
Patients are followed monthly for 6 months and then every 3 months thereafter
PROJECTED ACCRUAL A total of 24-70 patients 12-35 per cohort will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UCLA-0309060 | None | None | None |
| ABI-CA014 | None | None | None |