NCT00680758

Cisplatin, Paclitaxel, and Everolimus in Treating Patients With Metastatic Breast Cancer

A Phase I Study of Cisplatin, Paclitaxel, and RAD001 Patients With Metastatic Breast Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Vanderbilt-Ingram Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy, such as cisplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving more than one drug (combination chemotherapy) together with everolimus may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of cisplatin, paclitaxel, and everolimus when given together for the treatment of patients with metastatic breast cancer.

Detailed description

OBJECTIVES: Primary * To establish the safety profile and the maximum tolerated dose of the combination of cisplatin, paclitaxel, and everolimus in patients with metastatic breast cancer. Secondary * To explore the antitumor activity of this regimen, in terms of response rate and time to progression in these patients. OUTLINE: This is a multicenter study. Patients receive cisplatin intravenously (IV) over 1 hour and paclitaxel IV over 1 hour on days 1, 8, and 15. Patients receive oral everolimus on days 1, 8, 15, and 21. Courses repeat every 4 weeks in the absence of disease progression and unaccepted toxicity. After completion of study therapy, patients are followed at 4 weeks.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	cisplatin	* Dose Level: -3 20mg/m2/week 3-6 patients * Dose Level: -2 20mg/m2/week 3-6 patients * Dose Level: -1 25mg/m2/week 3-6 patients * Dose Level: 1 25mg/m2/week 3-6 patients * Dose Level: 2 25mg/m2/week 3-6 patients * Dose Level: 3 25mg/m2/week 3-6 patients
DRUG	everolimus	* Dose Level: -3 20mg/m2/week 3-6 patients * Dose Level: -2 20mg/m2/week 3-6 patients * Dose Level: -1 20mg/m2/week 3-6 patients * Dose Level: 1 20mg/m2/week 3-6 patients * Dose Level: 2 25mg/m2/week 3-6 patients * Dose Level: 3 30mg/m2/week 3-6 patients
DRUG	paclitaxel	* Dose Level: -3 65mg/m2/week 3-6 patients * Dose Level: -2 70mg/m2/week 3-6 patients * Dose Level: -1 70mg/m2/week 3-6 patients * Dose Level: 1 80mg/m2/week 3-6 patients * Dose Level: 2 80mg/m2/week 3-6 patients * Dose Level: 3 80mg/m2/week 3-6 patients

Timeline

• Start date: 2008-05-01
• Primary completion: 2009-08-01
• Completion: 2010-12-01
• First posted: 2008-05-20
• Last updated: 2013-03-08

Locations

4 sites across 1 country: United States