NCT01031446

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

A Phase Ib/II Study of Cisplatin, Paclitaxel, and RAD001 in Patients With Metastatic Breast Cancer

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 55 (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 and by blocking blood flow to the tumor. Giving cisplatin and paclitaxel together with everolimus may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects of giving cisplatin and paclitaxel together with everolimus and to see how well it works in treating patients with metastatic breast cancer.

Detailed description

OBJECTIVES: Primary * Safety profile of cisplatin, paclitaxel, and everolimus (RAD001) in patients with metastatic breast cancer. (Phase I) * Progression-free survival (Phase II) Secondary * Overall response rate * Time to progression * Number of patients with worst-grade toxicities Tertiary * To determine p53, p63, p73, and phosphatase and tensin homolog (PTEN) levels by immunohistochemistry (IHC). * To screen for exon 9 (E542K and E545K), exon 20 (H1047R), and phosphatidylinositol 3-kinase (PI3K) (p110α) mutations in DNA extracted from paraffin blocks. * To correlate IHC results with clinical outcome and with the different subtypes of breast cancer determined by molecular classification (basal-type vs luminal A vs luminal B) based on microarrays of RNA extracted from formalin-fixed paraffin-embedded blocks. * To generate microarrays of RNA extracted from fresh-frozen core biopsies (when available) to identify a pretreatment gene signature that mirrors the established p63 and p73 gene signatures that predict response to treatment. OUTLINE: This is a multicenter study. Patients receive oral everolimus once daily on days 1-28 and cisplatin IV over 1 hour and paclitaxel IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Tumor tissue samples are collected at baseline for correlative studies. After completion of study treatment, patients are followed up at 4 weeks.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	cisplatin	Given through a vein in the arm 1 time a week for 3 weeks, then a one week break and then begin the process again.
DRUG	everolimus	Taken daily by mouth.
DRUG	paclitaxel	Given through a vein in the arm 1 time a week for 3 weeks, then a one week break and then begin the process again.
OTHER	laboratory biomarker analysis	Blood collection

Timeline

• Start date: 2009-10-01
• Primary completion: 2011-12-01
• Completion: 2017-08-01
• First posted: 2009-12-14
• Last updated: 2018-08-31
• Results posted: 2013-03-11

Locations

4 sites across 1 country: United States