Ignite Creation Date:
2024-05-05 @ 5:11 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00404235
Status:
COMPLETED
Last Update Posted:
2018-10-16
First Post:
2006-11-27
Brief Title:
Carboplatin and ABI-007 in Treating Patients With Stage IV Melanoma That Cannot Be Removed By Surgery
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
A Phase II Trial of Carboplatin CBDCA and ABI-007ABX in Patients With Unresectable Stage IV Melanoma
Status:
COMPLETED
Status Verified Date:
2018-09
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 carboplatin and ABI-007 work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving more than one drug combination chemotherapy may kill more tumor cells
PURPOSE This phase II trial is studying the side effects and how well giving carboplatin together with ABI-007 works in treating patients with stage IV melanoma that cannot be removed by surgery
PURPOSE This phase II trial is studying the side effects and how well giving carboplatin together with ABI-007 works in treating patients with stage IV melanoma that cannot be removed by surgery
Detailed Description:
OBJECTIVES
Primary
Assess the safety and antitumor activity of carboplatin and paclitaxel albumin-stabilized nanoparticle formulation ABI-007 in patients with unresectable stage IV melanoma who have not received prior chemotherapy for their metastatic disease Cohort 1
Assess the safety and antitumor activity of this regimen in patients with unresectable stage IV melanoma who have received prior chemotherapy for their metastatic disease Cohort 2
Secondary
Describe the impact of this regimen on parameters of immune function and angiogenesis in these patients
OUTLINE This is a multicenter study Patients are stratified according to prior chemotherapy for metastatic disease yes vs no
Patients receive paclitaxel albumin-stabilized nanoparticle formulation ABI-007 IV over 30 minutes followed by carboplatin IV over 30 minutes on days 1 8 and 15 Treatment repeats every 28 days for at least 8 courses in the absence of disease progression or unacceptable toxicity
Blood and tumor tissue samples are collected periodically to evaluate secreted protein acidic and rich in cysteine SPARC content of tumor tissue by immunohistochemistry and to explore the impact of therapy on immune homeostasis Samples are also analyzed by immunoenzyme techniques for angiogenesis markers
After completion of study treatment patients are followed periodically for up to 2 years
PROJECTED ACCRUAL A total of 74 patients will be accrued for this study
Primary
Assess the safety and antitumor activity of carboplatin and paclitaxel albumin-stabilized nanoparticle formulation ABI-007 in patients with unresectable stage IV melanoma who have not received prior chemotherapy for their metastatic disease Cohort 1
Assess the safety and antitumor activity of this regimen in patients with unresectable stage IV melanoma who have received prior chemotherapy for their metastatic disease Cohort 2
Secondary
Describe the impact of this regimen on parameters of immune function and angiogenesis in these patients
OUTLINE This is a multicenter study Patients are stratified according to prior chemotherapy for metastatic disease yes vs no
Patients receive paclitaxel albumin-stabilized nanoparticle formulation ABI-007 IV over 30 minutes followed by carboplatin IV over 30 minutes on days 1 8 and 15 Treatment repeats every 28 days for at least 8 courses in the absence of disease progression or unacceptable toxicity
Blood and tumor tissue samples are collected periodically to evaluate secreted protein acidic and rich in cysteine SPARC content of tumor tissue by immunohistochemistry and to explore the impact of therapy on immune homeostasis Samples are also analyzed by immunoenzyme techniques for angiogenesis markers
After completion of study treatment patients are followed periodically for up to 2 years
PROJECTED ACCRUAL A total of 74 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-2012-02705 | REGISTRY | None | None |
| CDR0000514561 | REGISTRY | PDQ Physician Data Query | None |