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Study of Temsirolimus, Erlotinib and Cisplatin in Solid Tumors

NCT00998036 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2017-12-13

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Temsirolimus

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

DRUG

Cisplatin

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.

DRUG

Erlotinib

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

Sponsors & Collaborators

  • Wyeth is now a wholly owned subsidiary of Pfizer

    collaborator INDUSTRY

  • Genentech, Inc.

    collaborator INDUSTRY

  • Columbia University

    lead OTHER

Principal Investigators

  • Kevin Kalinksy, MD · Columbia University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2012-06-30
Completion
2012-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT00998036 on ClinicalTrials.gov