Phase I of Biologics and Chemoradiation Therapy for Advanced Head and Neck Cancer
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|ClinicalTrials.gov Identifier: NCT00405405|
Recruitment Status : Completed
First Posted : November 30, 2006
Last Update Posted : October 21, 2016
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer Parotid Gland Cancer Thyroid Gland Cancer Melanoma Stage IV Head and Neck Cancer||Drug: Cisplatin Drug: Docetaxel Drug: Bevacizumab Drug: Erlotinib Radiation: Radiotherapy||Phase 1|
Locally advanced non-operative, Stage IV head and neck cancer has at best a guarded prognosis. Improvements in outcome have been achieved via the combination of chemotherapy and radiotherapy. Concurrent chemoradiotherapy is needed to optimize results, although recent data suggest a benefit from induction therapy as well. Nonetheless, despite high remission rates, most of these patients will suffer local-regional and/or distant recurrence from their disease.
The proposed study will build upon the framework of chemoradiotherapy (induction plus concurrent) via the addition of a double biologic therapy. Specifically, the combination of bevacizumab and erlotinib will be used, as has been studied in other types of cancer.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of the Combination of Chemoradiotherapy With Biologic Therapy for Advanced Head and Neck Cancer|
|Study Start Date :||December 2006|
|Actual Primary Completion Date :||June 2010|
|Actual Study Completion Date :||June 2010|
A combination of Cisplatin, Docetaxel, Bevacizumab, Erlotinib, and Radiotherapy
Other Name: Taxotere
Other Name: Avastin
Radiotherapy begins as soon as possible following neoadjuvant chemotherapy, and continues for 7 weeks
- Bevacizumab and Erlotinib Combined with Chemoradiotherapy for the Treatment of Advanced Head and Neck Cancer [ Time Frame: Day 36 ]To determine if bevacizumab and erlotinib can be safely combined with chemoradiotherapy for advanced head and neck cancer.
- Determination of Dose Limiting Toxicity (DTL) [ Time Frame: 30 days ]To determine the appropriate dosing strategy for bevacizumab/erlotinib when combined with chemoradiotherapy for advanced head and neck cancer.
- Complete Remission Rate [ Time Frame: 6 months ]To obtain preliminary data on the complete remission rate for this treatment combination.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00405405
|United States, Pennsylvania|
|Thomas Jefferson University|
|Philadelphia, Pennsylvania, United States, 19107|
|Principal Investigator:||Pramila Rani Anne, MD||Thomas Jefferson University|