Study Stopped
Low Accrual, Funding
Erlotinib (Tarceva) During First Line Standard Platinum Containing Chemo for Advanced Squamous Cell Head and Neck Cancer
Erlotinib (Tarceva) Given Intermittently During First Line Standard Platinum Containing Chemotherapy for Advanced Squamous Cell Carcinoma of the Head and Neck
1 other identifier
interventional
6
0 countries
N/A
Brief Summary
The purpose of this study is to determine if combination Erlotinib, Cisplatin/Carboplatin, and Paclitaxel are effective first line treatment for metastatic, recurrent and persistent squamous cell carcinoma of the head and neck.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 head-and-neck-cancer
Started Feb 2007
Typical duration for phase_2 head-and-neck-cancer
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2007
CompletedFirst Submitted
Initial submission to the registry
March 14, 2007
CompletedFirst Posted
Study publicly available on registry
March 16, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedResults Posted
Study results publicly available
March 18, 2025
CompletedMarch 18, 2025
February 1, 2025
4.9 years
March 14, 2007
January 12, 2023
February 26, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Tumor Response Rate of Intermittent Tarceva During First Line Standard Platinum Containing Chemotherapy
Response rate of intermittent Tarceva will be measured by applying RECIST 1.0 criteria to measure response using radiologic testing.
Evaluated at 6-week intervals, up to an average of 18 weeks.
Study Arms (1)
Erlotinib
EXPERIMENTALErlotinib (Tarceva) During First Line Standard Platinum Containing Chemo
Interventions
loading dose of 300 mg on Day 2 followed by 150 mg daily Days 3 - 17 of each cycle of paclitaxel and cisplatin/carboplatin
Eligibility Criteria
You may qualify if:
- Squamous cell carcinoma of the head and neck region that is metastatic, recurrent or persistent after surgery and/or radiation
- No prior chemotherapy for metastatic, recurrent or persistent disease
You may not qualify if:
- Not more than 1 prior adjuvant or neoadjuvant chemotherapy regimen is allowed
- Chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Henry Ford Health Systemlead
- Genentech, Inc.collaborator
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
the study did not accrue fully and was closed due to poor accrual
Results Point of Contact
- Title
- Tiffany Pearce, Director of Clinical Trials
- Organization
- Henry Ford Health System
Study Officials
- PRINCIPAL INVESTIGATOR
Haythem Ali, M.D/
Henry Ford Health System
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Staff Physician
Study Record Dates
First Submitted
March 14, 2007
First Posted
March 16, 2007
Study Start
February 1, 2007
Primary Completion
January 1, 2012
Study Completion
January 1, 2012
Last Updated
March 18, 2025
Results First Posted
March 18, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share