NCT00442260

Doxorubicin HCL Liposome Injection (DOXIL) in Combination With Abraxane in Patients With Metastatic Breast Cancer

Dose Finding and Efficacy Evaluation of DOXIL (Doxorubicin HCL Liposome Injection) in Combination With Abraxane (Abraxane) in Patients With Metastatic Breast Cancer (MBC) [Phase I and II]

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: West Virginia University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Dose Finding and Efficacy Evaluation of DOXIL (Doxorubicin HCL Liposome Injection) in Combination with Abraxane (Abraxane) in Patients with Metastatic Breast Cancer (MBC) \[Phase I and II\]

Detailed description

Phase I Objectives * To determine the Maximum Tolerated Dose (MTD) of the combination of (DOXIL) and Abraxane in patients with Metastatic Breast Cancer (MBC). * Determine the dose-limiting toxicity (DLT) of DOXIL and Abraxane. Phase II Objectives Primary Objective * To determine the response rate of DOXIL and Abraxane in patients with MBC. Secondary Objectives * To determine the time to disease progression in patients with MBC receiving DOXIL and Abraxane. * To assess the tolerability of this regimen in women with MBC and assess toxicity profile

Conditions

• Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	DOXIL
DRUG	Abraxane

Timeline

• Start date: 2007-02-01
• Primary completion: 2008-10-01
• Completion: 2008-10-01
• First posted: 2007-03-01
• Last updated: 2021-01-22
• Results posted: 2021-01-22

Locations

1 site across 1 country: United States