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Alkylating Agent
OSI-774 + Chemotherapy for Head and Neck Cancer
Phase 2
Waitlist Available
Led By Xiuning Le, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Normal organ and marrow function
History of non-melanoma skin cancer, or other malignancies treated 5 years or more prior to the current tumor, from which the patient has remained continually disease-free
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion; and average of 1 year
Awards & highlights
Study Summary
This trial is studying if a new combination of drugs is effective in treating head and neck cancer. The safety of the treatment will also be looked at.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Possible side effects include reactions related to infusion treatments, fatigue, digestive issues like nausea or diarrhea, blood-related problems such as low counts leading to increased infection risk, skin reactions, and potential organ inflammation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My organs and bone marrow are functioning normally.
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I had cancer other than melanoma over 5 years ago and have been cancer-free since.
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I can take care of myself but might not be able to do heavy physical work.
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My cancer is a type of head and neck cancer that has spread or come back.
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I am currently not suffering from any sudden illnesses or infections.
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I am 18 years old or older.
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I have a tumor that can be measured and is at least as big as specified.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion; and average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion; and average of 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Response Rate
Secondary outcome measures
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) v3.0
Trial Design
1Treatment groups
Experimental Treatment
Group I: Cisplatin + Docetaxel + OSI-774Experimental Treatment3 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Erlotinib
FDA approved
Docetaxel
FDA approved
Cisplatin
FDA approved
Find a Location
Who is running the clinical trial?
Aventis PharmaceuticalsIndustry Sponsor
80 Previous Clinical Trials
16,731 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,541 Previous Clinical Trials
568,041 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
2,976 Previous Clinical Trials
1,789,458 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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 have received treatment targeting EGFR before.I am currently being treated for an infection.I am on anti-retroviral therapy for an immune deficiency.I can take care of myself but might not be able to do heavy physical work.I've had chemotherapy or radiotherapy for my recurring or spreading head and neck cancer.My cancer is a type of head and neck cancer that has spread or come back.I am a woman or identify as part of a minority group.I am currently not suffering from any sudden illnesses or infections.My cancer has spread to my brain.I need nutrition through an IV including fats.I have moderate to severe nerve damage.My cancer is not squamous cell carcinoma.I am 18 years old or older.I am unwilling to sign the informed consent.I do not have any uncontrolled illnesses.I have a tumor that can be measured and is at least as big as specified.I haven't had chemotherapy for my head or neck cancer that has returned or spread.
Research Study Groups:
This trial has the following groups:- Group 1: Cisplatin + Docetaxel + OSI-774
Awards:
This trial has 3 awards, including:- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What has been established about the safety profile of OSI-774?
"Though there is a degree of evidence pointing to the safety of OSI-774, its efficacy has yet to be established. As such, it was assigned a score of 2 on our team's scale from 1 to 3."
Answered by AI
What medicinal purpose does OSI-774 typically serve?
"OSI-774 has been known to successfully combat metastatic pancreatic cancer, pancreatic carcinoma, and malignant esophageal neoplasms."
Answered by AI
Are recruitment efforts underway for this clinical trial?
"This particular medical experiment is currently not accepting patients. Initially posted on January 28th 2004 and last updated November 16th 2022, it has since been filled. However, there are 1026 clinical trials for head and neck cancer that still require participants as well as 973 additional studies searching for subjects to trial OSI-774."
Answered by AI
How many participants have been recruited for this research project?
"Unfortunately, this particular clinical trial has closed its recruitment process. It was initially posted on the 28th of January 2004 before being updated lastly on November 16th 2022. If you are still looking to take part in a medical study, there is an abundance of trials with 1026 actively recruiting patients suffering from head and neck cancer while 973 studies need participants for OSI-774 treatment."
Answered by AI
Is there any precedent for using OSI-774 in clinical research?
"Currently, over 900 studies are actively studying the effects of OSI-774 with almost 400 in their final phase. Although most trials are situated around Shanghai, there is a wide expanse of 65074 locations across the world conducting research on this drug."
Answered by AI
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