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

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 — RADIATION
    Radiotherapy 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: Treatment
    A 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)

FacilityCityStateZIPSite coordinators
Thomas Jefferson UniversityPhiladelphiaPennsylvania19107-

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