NCT00680758

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at P25-P50 for phase_1 breast-cancer

Timeline
Completed

Started May 2008

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

May 18, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 20, 2008

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

March 8, 2013

Status Verified

March 1, 2013

Enrollment Period

1.3 years

First QC Date

May 18, 2008

Last Update Submit

March 7, 2013

Conditions

Breast Cancer

Keywords

male breast cancerstage IV breast cancer

Outcome Measures

Primary Outcomes (1)

  • Safety profile and maximum tolerated dose

    The Maximum Tolerated Dose (MTD) will be the dose level at which fewer than 2 of 6 (or 33% of) patients experience dose limiting toxicity (DLT).

    At 4 weeks

Secondary Outcomes (3)

  • Antitumor activity

    Date of study entry to date of progression of disease

  • Response rate

    at baseline and every 8 weeks to disease progression

  • Time to progression

    date of study entry to date of disease progression

Study Arms (1)

Therapeutic Intervention

EXPERIMENTAL
Drug: cisplatinDrug: everolimusDrug: paclitaxel

Interventions

cisplatinDRUG

* 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

Also known as: Platinol
Therapeutic Intervention
everolimusDRUG

* 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

Also known as: RAD001
Therapeutic Intervention
paclitaxelDRUG

* 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

Also known as: Taxol
Therapeutic Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed invasive mammary carcinoma
  • Stage IV disease
  • No locally recurrent breast cancer
  • Patients with HER2/neu overexpressing tumors must have received prior trastuzumab (Herceptin®) in first-line treatment of metastatic breast cancer
  • Patients with estrogen receptor- or progesterone receptor-expressing tumors must have received prior endocrine therapy (i.e., aromatase inhibitors, fulvestrant, tamoxifen, or ovarian ablation) in first-line treatment of metastatic breast cancer
  • No symptomatic brain metastases
  • Patients with a history of brain metastases must be clinically stable and not taking steroids or therapeutic anticonvulsants that are CYP3A4 modifiers
  • Patients with asymptomatic brain metastases on prophylactic convulsants that are CYP3A4 modifiers are not eligible
  • Hormone receptor status not specified
  • PATIENT CHARACTERISTICS:
  • Menopausal status not specified
  • ECOG performance status 0-1
  • Life expectancy ≥ 6 months
  • ANC ≥ 1000/mm\^3
  • +22 more criteria

You may not qualify if:

  • PRIOR CONCURRENT THERAPY:
  • See Disease Characteristics
  • Recovered from all prior treatment
  • Must not have exceeded a total cumulative dose of life-time exposure of doxorubicin hydrochloride ≤ 360 mg/m² or epirubicin hydrochloride ≤ 640 mg/m²
  • At least 2 weeks since other prior investigational drugs
  • No prior resection of the stomach or small bowel
  • No more than 4 prior chemotherapy regimens in the metastatic setting
  • This restriction does not include endocrine therapies or single agent biologic therapies (i.e., trastuzumab)
  • Concurrent radiotherapy to painful bone metastases or areas of impending bone fracture allowed as long as radiotherapy is initiated prior to study entry
  • No concurrent trastuzumab
  • No concurrent endocrine therapy
  • No concurrent CYP3A4 modifiers
  • No concurrent herbal supplement
  • No other concurrent anticancer therapy (chemotherapy, radiotherapy, surgery, immunotherapy, hormonal therapy, or biological therapy)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Vanderbilt-Ingram Cancer Center - Cool Springs

Nashville, Tennessee, 37064, United States

Location

Vanderbilt-Ingram Cancer Center at Franklin

Nashville, Tennessee, 37064, United States

Location

Sarah Cannon Cancer Center at Centennial Medical Center

Nashville, Tennessee, 37203, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232-6838, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsBreast Neoplasms, Male

Interventions

CisplatinEverolimusPaclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsSirolimusMacrolidesLactonesOrganic ChemicalsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsDiterpenesTerpenes

Study Officials

  • Ingrid Mayer, MD

    Vanderbilt-Ingram Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine; Clinical Director, Breast Cancer Program; Medical Oncologist

Study Record Dates

First Submitted

May 18, 2008

First Posted

May 20, 2008

Study Start

May 1, 2008

Primary Completion

August 1, 2009

Study Completion

December 1, 2010

Last Updated

March 8, 2013

Record last verified: 2013-03

Locations

US(4)