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Squamous Cell CarcinomaPhase 2NCT01009203

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

A Phase 2 study testing Erlotinib and Temsirolimus in people with Squamous Cell Carcinoma, run by New Mexico Cancer Research Alliance at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Squamous Cell Carcinoma
What is being tested?
Erlotinib and Temsirolimus
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
2 sitesUnited States
Study dates
Dec 2009to Dec 2012
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologically confirmed squamous cell carcinoma of the head and neck, from any primary site. Nasopharyngeal carcinoma, World Health Organization (WHO) Grade I, will be included.
  • Advanced disease, fulfilling one of the criteria defined below:
  • Incurable disease as assessed by surgical or radiation oncology
  • Metastatic (M1) disease
  • Persistent or progressive disease following curative-intent radiation, and not a candidate for surgical salvage due to incurability or morbidity
  • Platinum-refractory or platinum-ineligible, fulfilling one of the criteria defined below:
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  • disease progression during or after 4-6 cycles of platinum-containing therapy in the advanced setting
  • disease progression within 6 months of curative-intent treatment, which included platinum-based chemotherapy
  • ineligible for platinum-containing therapy, in the opinion of the medical oncologist, due to medical comorbidities or unacceptable risk for toxicity
  • patient refuses platinum-containing therapy
  • Measurable disease based on response evaluation criteria in solid tumors (RECIST)
  • disease in previously irradiated sites is considered measurable if there has been unequivocal progression of the lesion after radiotherapy, or the lesion contains residual carcinoma by biopsy more than 6 weeks after completion of radiotherapy
  • Easter Cooperative Oncology Group (ECOG) performance status 0-2 at time of informed consent
  • Adequate hematologic reserve and organ function
  • Absolute neutrophil count > 1200/µl
  • Platelet count > 100,000/µl
  • Renal function: Serum Creatinine ≤ 1.5x upper limit of normal (ULN)
  • Liver function: Total bilirubin ≤ 1.5x ULN, Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5x ULN
  • Able to provide written, voluntary consent
  • Patients with reproductive potential must use an effective contraceptive method.
  • Male or female, age ≥ 18 years
  • Life expectancy ≥ 12 weeks

Who cannot join

  • Nasopharyngeal primary site, if WHO grade II or III
  • Prior treatment blocking the epidermal growth factor receptor (EGFR), in the advanced disease setting
  • Prior treatment blocking EGFR in the curative-intent setting, if delivered in the previous 6 months
  • Prior treatment with a drug blocking the mammalian target of rapamycin (mTOR)
  • Sensitivity to temsirolimus or erlotinib
  • Uncontrolled metastatic disease of the central nervous system
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  • Radiotherapy within the 2 weeks before Cycle 1' Day 1
  • Surgery within the 2 weeks before Cycle 1' Day 1
  • Pregnant or lactating females
  • Myocardial infarction or ischemia within the 6 months preceding study treatment
  • Any co morbid condition that' in the view of the attending physician' renders the patient at high risk from treatment complications
  • No other concurrent, investigational anti-neoplastic agent will be permitted
  • History of prior malignancy within the prior five years, with the exception of non-melanoma carcinomas of the skin, and carcinoma in situ of the cervix

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • University of New Mexico Cancer Center @ Lovelace Medical Center

    Albuquerque, New Mexico, 87102

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87106

Other trials in United States

About this study

Official title: A Phase II Study of Temsirolimus (Torisel®) and Erlotinib (Tarceva®) in Platinum-Refractory or -Ineligible, Advanced, Squamous Cell Carcinoma of the Head and Neck

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.

Read the detailed description

This is a phase II, multicenter, single arm, open-label study. Thirty-seven patients with advanced, platinum-refractory or platinum-ineligible squamous cell carcinoma of the head and neck will be sequentially enrolled to a single treatment arm. Patients will be treated with continuous, 28-day cycles of 150 mg of erlotinib by mouth daily and 15 mg of temsirolimus intervenously weekly. In the absence of grade 3 or higher toxicity in the first cycle, a single, intra-patient dose increase to 20 mg temsirolimus will be permitted.

Being tested
Erlotinib, Temsirolimus
Keywords
squamous cell carcinoma, head, neck, aerodigestive
Medical subject headings
Carcinoma, Squamous Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ErlotinibDrug

    Also called Tarceva, OSI-774

    Treatment will continue until disease progression, unacceptable toxicity, or withdrawal of informed consent.

  • TemsirolimusDrug

    Also called Torisel, CCI-779

    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 groups in NCT01009203
Study groupRoleWhat they receive
Temsirolimus and ErlotinibExperimentalErlotinib (Tarceva) at 150 mg by mouth daily + Temsirolimus (Torisel) at 15 mg intravenously weekly. Each cycle is comprised of 28 days
Receives: Drug: Erlotinib; Drug: Temsirolimus

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival (PFS)

    The time from treatment initiation to disease progression or death by any cause. Progression is evaluated according to modified Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by computerized tomography (CT) or magnetic resonance imaging (MRI): Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or unequivocal progression of existing non-target lesion, the appearance of new lesions, death due to disease without prior objective documentation of progression, or global deterioration in health status attributable to disease requiring a change in therapy without objective evidence of progression.

    Measured: 3 years

Secondary outcomes (3)

  1. Toxicity Profile

    Toxicities (i.e. Adverse Events) are evaluated prior to each treatment and during any clinical visit. Toxicity will be evaluated per National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. The number of patients affected by adverse events of grade 3 or higher will be reported.

    Measured: 3 years

  2. Overall Response Rate (ORR)

    Tumor response is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by computerized tomography (CT) or magnetic resonance imaging (MRI:) Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions. Overall response rate (ORR) is the sum of the percentages of patients achieving complete and partial responses

    Measured: 3 years

  3. Overall Survival (OS)

    The time from treatment initiation to death by any cause

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2009 (estimated)
  2. Study startDec 2009
  3. Primary completionSep 2012
  4. Study completionDec 2012

Why it stopped: High patient withdrawal rate

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01009203
Sponsor's protocol ID
INST OSI4641s
Other IDs
OSI4641s, NCI-2011-02948
Status last verified
Jul 2015
First submitted
5 Nov 2009
Last updated
10 Aug 2015
Data monitoring committee
Yes

Publications

  • Bauman JE, Arias-Pulido H, Lee SJ, Fekrazad MH, Ozawa H, Fertig E, Howard J, Bishop J, Wang H, Olson GT, Spafford MJ, Jones DV, Chung CH. A phase II study of temsirolimus and erlotinib in patients with recurrent and/or metastatic, platinum-refractory head and neck squamous cell carcinoma. Oral Oncol. 2013 May;49(5):461-7. doi: 10.1016/j.oraloncology.2012.12.016. Epub 2013 Feb 4.

    PubMed 23384718

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Erlotinib and Temsirolimus in people with Squamous Cell Carcinoma, run by New Mexico Cancer Research Alliance at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 10 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Aug 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01009203, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2015.

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