OSI-774 + Chemotherapy for Head and Neck Cancer

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Xiuning Le, M.D., Ph.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The goal of this clinical research study is to learn if giving the new drug, Tarceva® (OSI-774), in combination with Platinol® (cisplatin) and Taxotere® (docetaxel) is effective in the treatment of metastatic or recurrent head and neck cancer. The safety of this treatment will also be studied.

Research Team

Xiuning Le, M.D., Ph.D.

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

Adults with metastatic or recurrent head and neck squamous cell carcinoma who haven't had systemic chemotherapy for this condition. They must have measurable disease, be in a stable health condition, not pregnant, willing to use contraception, and without severe allergies to the drugs being tested.

Inclusion Criteria

My organs and bone marrow are functioning normally.

I had cancer other than melanoma over 5 years ago and have been cancer-free since.

I can take care of myself but might not be able to do heavy physical work.

Exclusion Criteria

History of allergic reactions attributed to compounds of similar chemical or biologic composition to OSI-774 or other agents used in the study

I have received treatment targeting EGFR before.

I am currently being treated for an infection.

Treatment Details

Interventions

• Cisplatin (Alkylating Agent)
• Docetaxel (Taxane)
• OSI-774 (Tyrosine Kinase Inhibitor)

Trial Overview The trial is testing the effectiveness and safety of combining Tarceva (OSI-774) with Platinol (cisplatin) and Taxotere (docetaxel) in treating advanced head and neck cancer. It aims to see if this new drug combination can help patients.

Participant Groups

Group I: Cisplatin + Docetaxel + OSI-774 Experimental Treatment 3 Interventions

Cisplatin 75 mg/m\^2 IV every 21 days. Docetaxel 60 mg/m\^2 IV repeated every 21 days. OSI-774 100 mg oral administered daily. May have a dose escalation of 150 mg pending on prior dose toleration. Patients will continue on daily OSI-774 until a study endpoint or removal from study is reached.

Cisplatin is already approved in Canada, Japan for the following indications:

Approved in Canada as Platinol for:

• Testicular cancer
• Ovarian cancer
• Cervical cancer
• Bladder cancer
• Head and neck cancer
• Esophageal cancer
• Lung cancer
• Mesothelioma
• Brain tumors
• Neuroblastoma

Approved in Japan as Platinol for:

• Testicular cancer
• Ovarian cancer
• Cervical cancer
• Bladder cancer
• Head and neck cancer
• Esophageal cancer
• Lung cancer
• Mesothelioma
• Brain tumors
• Neuroblastoma

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Dr. Peter WT Pisters

M.D. Anderson Cancer Center

Chief Executive Officer since 2017

MD from University of Western Ontario

Dr. Jeffrey E. Lee

M.D. Anderson Cancer Center

Chief Medical Officer

MD from Stanford University School of Medicine

Aventis Pharmaceuticals

Industry Sponsor

Trials

81

Recruited

15,000+

Paul Hudson

Aventis Pharmaceuticals

Chief Executive Officer since 2019

Degree in Economics from Manchester Metropolitan University

Christopher Corsico

Aventis Pharmaceuticals

Chief Medical Officer

MD from Cornell University, MPH in Chronic Disease Epidemiology from Yale University

Genentech, Inc.

Industry Sponsor

Trials

1,578

Recruited

569,000+

Ashley Magargee

Genentech, Inc.

Chief Executive Officer since 2024

MBA from Harvard University, BA from Princeton University

Levi Garraway

Genentech, Inc.

Chief Medical Officer since 2021

MD, PhD