Study of Temsirolimus, Erlotinib and Cisplatin in Solid Tumors

Part of paid clinical trials in New York, New York.

Sponsor
Columbia University
Study ID
NCT00998036
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Temsirolimus — DRUG
    Temsirolimus will be administered intravenously weekly on days one and eight of a three week cycle. Temsirolimus will not be given on week three (usually dosed weekly) for increased tolerability given its possible plasma accumulation during week three. Temsirolimus will be given second over a 30 minute infusion during posthydration. Dose escalation will follow the standard 3 by 3 design with three set dosing levels. Dose Level 1: Temsirolimus 15mg Dose Level 2: Temsirolimus 15mg Dose Level 3: Temsirolimus 25mg
  • Cisplatin — DRUG
    Cisplatin at 30mg/m2 will be administered intravenously weekly on days one and eight of a three week cycle. Cisplatin will be given first over a 30 minute infusion with prehydration.
  • Erlotinib — DRUG
    Erlotinib will be taken by mouth daily starting at 100mg. On days of cisplatin and temsirolimus infusions, erlotinib should be taken at least two hours after the beginning of the temsirolimus infusion. Dose escalation will follow the standard 3 by 3 design with three set dosing levels. Dose Level 1: Erlotinib 100mg Dose Level 2: Erlotinib 150mg Dose Level 3: Erlotinib 150mg

Study Details

This is a Phase I research study designed to determine the maximum tolerated dose (MTD) of cisplatin, temsirolimus, and erlotinib in combination for treatment in triple negative breast cancer (TNBC) patients.

Key Dates

First listed
Oct 20, 2009
Start date
Sep 30, 2009
Status verified
Dec 2017
Primary completion
Jun 30, 2012
Completion
Oct 31, 2012

Study Design

Enrollment
9 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Temsirolimus, cisplatin, erlotinib
    Cisplatin and temsirolimus will be administered weekly on days one and eight of a three week cycle. Erlotinib will be taken by mouth daily.

Primary Outcome Measure

Maximum Tolerated Dose (MTD) of Cisplatin [ Time Frame: 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Columbia University Medical CenterNew YorkNew York10032-

Find similar trials in New York, NY

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Columbia University Medical Center· New York, NY

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