Erlotinib (Tarceva) During First Line Standard Platinum Containing Chemo for Advanced Squamous Cell Head and Neck Cancer

Phase 2

Terminated

• Conditions: Head and Neck Cancer; Carcinoma, Squamous Cell
• Interventions: Drug: Erlotinib

• Registration Number: NCT00448240
• Lead Sponsor: Henry Ford Health System

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.

Detailed Description

We hypothesize that Erlotinib fails to enhance the effects of chemotherapy on response and survival because of Erlotinib's cytostatic effect, this results in a slowing down of the cell cycle, this in turn results in a hampering of the cytotoxic effect of chemotherapy leading to a lack of synergism with the combination. We propose that a sequential approach to the combination allows each drug to be used in its optimum time, by sequencing the Erlotinib, giving it 24 hours after chemotherapy we allow the chemotherapy to exert its effect with cells actively in cell cycle, but delivering the Erlotinib at a time when cells are trying to return to cell cycle hence slowing the growth rate of the tumor cell population. By withdrawing the Erlotinib about 4 days prior to the next chemotherapy cycle, we allow the cells to go back into cell cycle and therefore become susceptible to chemotherapy again.

Patients will be treated with intravenous paclitaxel over 3 hours followed by intravenous cisplatin/carboplatin on Day 1 of each 21 day cycle. Patients will be treated with Erlotinib at a loading dose of 300mg on Day 2 followed by 150 mg orally daily from Days 3-17 of each cycle of paclitaxel and cisplatin/carboplatin.

The primary objectives of this study are to assess the response rate of combination of erlotinib, cisplatin/carboplatin and paclitaxel in the first line treatment setting of metastatic, recurrent and persistent squamous cell carcinoma of the head and neck. Secondary objectives are to assess toxicity, median survival, and progression free survival.

Study Timeline

• Study Start: 2007-02
• Study First Submitted: 2007-03-14
• Study First Submitted QC: 2007-03-14
• Study First Posted: 2007-03-16
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Results First Submitted: 2023-01-12
• Status Verified: 2025-02
• Results First Submitted QC: 2025-02-26
• Last Update Submitted: 2025-02-26
• Results First Posted: 2025-03-18
• Last Update Posted: 2025-03-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Erlotinib	Erlotinib	Erlotinib (Tarceva) During First Line Standard Platinum Containing Chemo

Primary Outcome Measures

Name	Time	Method
Tumor Response Rate of Intermittent Tarceva During First Line Standard Platinum Containing Chemotherapy	Evaluated at 6-week intervals, up to an average of 18 weeks.	Response rate of intermittent Tarceva will be measured by applying RECIST 1.0 criteria to measure response using radiologic testing.