Phase I of Biologics and Chemoradiation Therapy for Advanced Head and Neck Cancer
Part of paid clinical trials in Philadelphia, Pennsylvania.
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
- Study ID
- NCT00405405
- Phase
- PHASE1
- Status
- Completed
Conditions
- Head and Neck Cancer
- Melanoma
- Parotid Gland Cancer
- Stage IV Head and Neck Cancer
- Thyroid Gland Cancer
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Cisplatin — DRUG* Two cycles during neoadjuvant therapy * Response assessment at approximately day 36 * Concurrent biochemoradiotherapy
- Docetaxel — DRUG* Two cycles during neoadjuvant therapy * Response assessment at approximately day 36 * Concurrent biochemoradiotherapy
- Bevacizumab — DRUG* Two cycles during neoadjuvant therapy * Response assessment at approximately day 36 * Concurrent biochemoradiotherapy
- Erlotinib — DRUG* Two cycles during neoadjuvant therapy (dose escalation) * Response assessment at approximately day 36 * Concurrent biochemoradiotherapy
- Radiotherapy — RADIATIONRadiotherapy begins as soon as possible following neoadjuvant chemotherapy, and continues for 7 weeks
Study Details
To determine a safe and effective doses of two biologic drugs, erlotinib and bevacizumab when used with chemotherapy and radiation therapy in advanced head and neck cancer
Key Dates
- First listed
- Nov 30, 2006
- Start date
- Dec 31, 2006
- Status verified
- May 2025
- Primary completion
- Jun 30, 2010
- Completion
- Jun 30, 2010
Study Design
- Enrollment
- 13 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: TreatmentA combination of Cisplatin, Docetaxel, Bevacizumab, Erlotinib, and Radiotherapy
Primary Outcome Measure
Bevacizumab and Erlotinib Combined with Chemoradiotherapy for the Treatment of Advanced Head and Neck Cancer [ Time Frame: Day 36 ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | - |
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