Temsirolimus (Torisel®) and Erlotinib (Tarceva®) in Platinum-Refractory/Ineligible, Advanced, Squamous Cell Carcinoma

Part of paid clinical trials in Albuquerque, New Mexico.

Sponsor
New Mexico Cancer Research Alliance
Study ID
NCT01009203
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Erlotinib — DRUG
    Treatment will continue until disease progression, unacceptable toxicity, or withdrawal of informed consent.
  • Temsirolimus — DRUG
    In the absence of Grade 3 or higher toxicity, a single, intra-patient dose increase of temsirolims to 20 mg intravenously weekly is permitted after the first 28 day cycle. Treatment will continue until disease progression, unacceptable toxicity, or withdrawal of informed consent.

Study Details

The primary hypothesis of this study is that the addition of mammalian target of rapamycin (mTOR) blockade to conventional epidermal growth factor receptor (EGFR) blockade will result in synergistic clinical activity in Squamous Cell Carcinoma of the Head and Neck (SCCHN), consistent with preclinical xenograft data. Patients will be treated with the combination of temsirolimus and erlotinib, at the previously established Maximal Tolerated Dose (MTD). The primary signal of efficacy will be progression free survival (PFS), anticipating that PFS will be prolonged compared to historical PFS in SCCHN patients treated with erlotinib or cetuximab monotherapy.

Key Dates

First listed
Nov 6, 2009
Start date
Dec 31, 2009
Status verified
Jul 2015
Primary completion
Sep 30, 2012
Completion
Dec 31, 2012

Study Design

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

Arms

  • Experimental: Temsirolimus and Erlotinib
    Erlotinib (Tarceva) at 150 mg by mouth daily + Temsirolimus (Torisel) at 15 mg intravenously weekly. Each cycle is comprised of 28 days

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: 3 years ]

Locations (2)

FacilityCityStateZIPSite coordinators
University of New Mexico Cancer CenterAlbuquerqueNew Mexico87106-
University of New Mexico Cancer Center @ Lovelace Medical CenterAlbuquerqueNew Mexico87102-

Find similar trials in Albuquerque, NM

By condition
Skin cancer
By specialty
OncologySkin cancerDermatology
By research site
University of New Mexico Cancer Center· Albuquerque, NMUniversity of New Mexico Cancer Center @ Lovelace Medical Center· Albuquerque, NM

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