Erlotinib and Temsirolimus for Solid Tumors

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT00770263
Phase
PHASE1
Status
Completed

Conditions

  • Solid Tumors

Eligibility Criteria

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

Interventions

Study Details

Define the maximum tolerated dose and dose limiting side-effects of temsirolimus in combination wtih erlotinib in patients with resistant solid tumors

Key Dates

First listed
Oct 9, 2008
Start date
May 31, 2009
Status verified
Dec 2014
Primary completion
Sep 30, 2014
Completion
Sep 30, 2014

Study Design

Enrollment
46 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Level 1A
    Erlotinib 100 mg administered orally on a once daily schedule for 35 days for the first cycle. Erlotinib 100 mg administered orally on a once daily schedule for 28 days for subsequent cycles. Temsirolimus 10 mg IV on days 8, 15, 22, and 29 during the first cycle. Temsirolimus 10 mg IV on days 8, 15, and 22 during subsequent cycles.
  • Experimental: Dose Level 1
    Erlotinib 100 mg administered orally on a once daily schedule for 35 days for the first cycle. Erlotinib 100 mg administered orally on a once daily schedule for 28 days for subsequent cycles. Temsirolimus 15 mg IV on days 8, 15, 22, and 29 during the first cycle. Temsirolimus 15 mg IV on days 8, 15, and 22 during subsequent cycles.
  • Experimental: Dose Level 2
    Erlotinib 100 mg administered orally on a once daily schedule for 35 days for the first cycle. Erlotinib 100 mg administered orally on a once daily schedule for 28 days for subsequent cycles. Temsirolimus 20 mg IV on days 8, 15, 22, and 29 during the first cycle. Temsirolimus 20 mg IV on days 8, 15, and 22 during subsequent cycles.
  • Experimental: Dose Level 3
    Erlotinib 100 mg administered orally on a once daily schedule for 35 days for the first cycle. Erlotinib 100 mg administered orally on a once daily schedule for 28 days for subsequent cycles. Temsirolimus 25 mg IV on days 8, 15, 22, and 29 during the first cycle. Temsirolimus 25 mg IV on days 8, 15, and 22 during subsequent cycles.
  • Experimental: Dose Expansion Phase
    Erlotinib 100 mg administered orally on a once daily schedule for 35 days for the first cycle. Erlotinib 100 mg administered orally on a once daily schedule for 28 days for subsequent cycles. Temsirolimus 25 mg IV on days 8, 15, 22, and 29 during the first cycle. Temsirolimus 25 mg IV on days 8, 15, and 22 during subsequent cycles.

Primary Outcome Measure

To define the maximum tolerated dose and dose-limiting toxicities of temsirolimus in combination with erlotinib in patients with resistant solid malignancies. [ Time Frame: 3 years for MTD to be determined, DLT occurs in 1st cycle only ]

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110-

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By research site
Washington University School of Medicine· St Louis, MO

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