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Study Evaluating Temsirolimus in Advanced Stage Squamous Cell Carcinoma of the Head & Neck

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NCT00195299

Last updated on October 13, 2019
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FOR MORE INFORMATION
Study Location
Shreveport, Louisiana, 71130 United States
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Contact
1-800-718-1021
[email protected]
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Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Squamous Cell Carcinoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Subjects with newly diagnosed, advanced stage, head and neck squamous cell carcinoma
of the oral cavity, oral pharynx, hypopharynx or larynx.

- Subjects willing to undergo tumor biopsies.

- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.

- Age >/= 18 years.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Subjects receiving anticoagulation therapy.

- Presence of unstable angina, recent myocardial infarction (within the previous 6
months), or use of ongoing maintenance therapy for life-threatening ventricular
arrhythmia.

- Prior cancer therapy (chemotherapy, hormonal therapy, radiotherapy, immunotherapy) or
investigational agent for their head and neck cancer.

NCT00195299
Pfizer
Completed
Study Evaluating Temsirolimus in Advanced Stage Squamous Cell Carcinoma of the Head & Neck

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Pfizer Clinical Trials Contact Center

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[email protected]

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Descriptive Information
Brief TitleStudy Evaluating Temsirolimus in Advanced Stage Squamous Cell Carcinoma of the Head & Neck
Official TitleAn Exploratory Biomarker Trail of Temsirolimus in Subjects With Newly Diagnosed Advanced Stage Squamous Cell Carcinoma of the Head & Neck
Brief SummaryThis is an open-label, exploratory, biomarker study of intravenous temsirolimus given once weekly for 3 weeks to newly diagnosed, advanced stage head and neck cancer subjects prior to beginning their standard therapy for their specific disease. The primary objective of this study is to identify biomarkers of temsirolimus activity.
Detailed DescriptionNot Provided
Study TypeObservational
Study DesignTime Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNot Provided
Study PopulationNot Provided
ConditionSquamous Cell Carcinoma
InterventionDrug: Temsirolimus
Study Groups/CohortsNot Provided
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment StatusCompleted
Enrollment
 (submitted: September 12, 2005)		20
Original EnrollmentSame as current
Actual Study Completion DateFebruary 2007
Primary Completion DateNot Provided
Eligibility Criteria

Inclusion Criteria:

  • Subjects with newly diagnosed, advanced stage, head and neck squamous cell carcinoma of the oral cavity, oral pharynx, hypopharynx or larynx.
  • Subjects willing to undergo tumor biopsies.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.
  • Age >/= 18 years.

Exclusion Criteria:

  • Subjects receiving anticoagulation therapy.
  • Presence of unstable angina, recent myocardial infarction (within the previous 6 months), or use of ongoing maintenance therapy for life-threatening ventricular arrhythmia.
  • Prior cancer therapy (chemotherapy, hormonal therapy, radiotherapy, immunotherapy) or investigational agent for their head and neck cancer.
Sex/Gender
Sexes Eligible for Study:All
Ages18 Years and older   (Adult, Older Adult)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesUnited States
Removed Location Countries  
 
Administrative Information
NCT NumberNCT00195299
Other Study ID Numbers3066K1-147
Has Data Monitoring CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyNot Provided
Study SponsorWyeth is now a wholly owned subsidiary of Pfizer
CollaboratorsNot Provided
Investigators
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
PRS AccountWyeth is now a wholly owned subsidiary of Pfizer
Verification DateDecember 2007

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]

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