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

NCT00680758 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2013-03-08

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Vanderbilt-Ingram Cancer Center

    lead OTHER

Principal Investigators

  • Ingrid Mayer, MD · Vanderbilt-Ingram Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2009-08-31
Completion
2010-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00680758 on ClinicalTrials.gov