NCT00265733

Paclitaxel Poliglumex and Capecitabine in Treating Patients With Metastatic Breast Cancer

Phase II Trial of CT-2103 (Xyotax™) With Capecitabine as First-Line Chemotherapy for Patients With Metastatic Breast Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy, such as paclitaxel poliglumex and capecitabine, 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 how well giving paclitaxel poliglumex together with capecitabine works in treating patients with metastatic breast cancer.

Detailed description

OBJECTIVES: * Assess the tumor response rate and adverse event profile in patients with metastatic, HER2 negative breast cancer treated with paclitaxel poliglumex (CT-2103; Xyotax™) and capecitabine. * Examine the distributions of disease-free progression times and survival times in these patients. OUTLINE: This is a multicenter study. Patients receive paclitaxel poliglumex IV (CT-2103; Xyotax™) over 10-20 minutes on day 1 and oral capecitabine twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 6 months for up to 5 years.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	capecitabine
DRUG	paclitaxel poliglumex

Timeline

• Start date: 2006-02-01
• Primary completion: 2007-08-01
• Completion: 2013-05-01
• First posted: 2005-12-15
• Last updated: 2016-12-06