Study Evaluating Temsirolimus in Advanced Stage Squamous Cell Carcinoma of the Head & Neck
NCT00195299
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Adult Trials: 18+ Years
- 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.
- 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.
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title | Study Evaluating Temsirolimus in Advanced Stage Squamous Cell Carcinoma of the Head & Neck | |||
| Official Title | An Exploratory Biomarker Trail of Temsirolimus in Subjects With Newly Diagnosed Advanced Stage Squamous Cell Carcinoma of the Head & Neck | |||
| Brief Summary | This 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 Description | Not Provided | |||
| Study Type | Observational | |||
| Study Design | Time Perspective: Prospective | |||
| Target Follow-Up Duration | Not Provided | |||
| Biospecimen | Not Provided | |||
| Sampling Method | Not Provided | |||
| Study Population | Not Provided | |||
| Condition | Squamous Cell Carcinoma | |||
| Intervention | Drug: Temsirolimus | |||
| Study Groups/Cohorts | Not 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 Status | Completed | |||
| Enrollment | 20 | |||
| Original Enrollment | Same as current | |||
| Actual Study Completion Date | February 2007 | |||
| Primary Completion Date | Not Provided | |||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender |
| |||
| Ages | 18 Years and older (Adult, Older Adult) | |||
| Accepts Healthy Volunteers | No | |||
| Contacts | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries | United States | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number | NCT00195299 | |||
| Other Study ID Numbers | 3066K1-147 | |||
| Has Data Monitoring Committee | Not Provided | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement | Not Provided | |||
| Responsible Party | Not Provided | |||
| Study Sponsor | Wyeth is now a wholly owned subsidiary of Pfizer | |||
| Collaborators | Not Provided | |||
| Investigators |
| |||
| PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||
| Verification Date | December 2007 | |||