OSI-774 + Chemotherapy for Head and Neck Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether a combination of three drugs—Tarceva® (OSI-774), Platinol®, and Taxotere®—can effectively treat head and neck cancer that has spread or returned. Researchers aim to determine if this new drug mix outperforms current treatments and ensure its safety for patients. Individuals with a confirmed diagnosis of metastatic or recurrent head and neck squamous cell carcinoma who have not previously received chemotherapy for it may qualify for this study. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you are receiving other investigational agents or certain treatments for HIV. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that a combination of the drugs Tarceva® (OSI-774), Platinol® (cisplatin), and Taxotere® (docetaxel) has been tested in patients with head and neck cancer. Studies have found that cisplatin and docetaxel are generally well-tolerated, meaning most patients can handle the side effects. These drugs work together to target and destroy cancer cells.
Patients have reported that the side effects of this combination are manageable and not too severe. Tarceva® is a newer drug in this mix but is generally considered safe when used with other chemotherapy drugs. Some patients might experience mild side effects, which can often be managed with medical help.12345Why do researchers think this study treatment might be promising for head and neck cancer?
Researchers are excited about the combination of OSI-774 with chemotherapy for head and neck cancer because it introduces a targeted approach that differs from the standard treatments like surgery, radiation, and conventional chemotherapy alone. OSI-774, also known as erlotinib, is a tyrosine kinase inhibitor that specifically targets the epidermal growth factor receptor (EGFR), which plays a crucial role in the growth and spread of cancer cells. By combining OSI-774 with traditional chemotherapy agents like cisplatin and docetaxel, this treatment aims to enhance the overall effectiveness by not only attacking cancer cells directly but also disrupting their growth signals. This targeted mechanism potentially offers a more efficient way to halt cancer progression with potentially fewer side effects compared to traditional treatments.
What evidence suggests that this trial's treatments could be effective for head and neck cancer?
This trial will evaluate the combination of cisplatin, docetaxel, and OSI-774 for treating head and neck cancers. Studies have shown that cisplatin and docetaxel together can be very effective, with manageable side effects. Participants in this trial will receive this combination along with OSI-774, which research suggests has shown promise for patients with advanced head and neck cancer. OSI-774 is already approved for treating a different type of cancer, supporting its potential effectiveness here. Overall, this combination aims to improve treatment outcomes by leveraging the strengths of each drug.13678
Who Is on the Research Team?
Xiuning Le, M.D., Ph.D.
Principal Investigator
M.D. Anderson Cancer Center
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive OSI-774 daily, and docetaxel and cisplatin every 3 weeks for 18 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension
Participants may continue receiving OSI-774 as long as their cancer responds to treatment
What Are the Treatments Tested in This Trial?
Interventions
- Cisplatin
- Docetaxel
- OSI-774
Cisplatin is already approved in European Union, United States, Canada, Japan for the following indications:
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
Aventis Pharmaceuticals
Industry Sponsor
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
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