OSI-774/Cisplatin/Taxotere in Head & Neck Squamous Cell Cancer
This trial is active, not recruiting.
|Condition||head and neck cancer|
|Treatments||docetaxel, osi-774, cisplatin|
|Sponsor||M.D. Anderson Cancer Center|
|Start date||January 2004|
|End date||January 2017|
|Trial size||50 participants|
|Trial identifier||NCT00076310, ID02-668|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
time frame: Every 6-8 weeks
Safety profile of OSI-774 in Conjunction with Cisplatin and Docetaxel
time frame: Patients will be evaluated every 2 months while receiving continued OSI-774.
Male or female participants at least 18 years old.
1. Have histologically or cytologically confirmed metastatic or recurrent head and neck
squamous cell carcinoma from the primary lesion and/or lymph nodes of the oral
cavity, oropharynx, hypopharynx, or larynx.
2. Have measurable disease, defined as at least one lesion that can be accurately
measured in at least one dimension (longest diameter to be recorded) as >= 20 mm with
conventional techniques or as >= 10 mm with spiral CT scan. See section 9.2 for the
evaluation of measurable disease.
3. Have not received any prior systemic chemotherapy for metastatic or recurrent head
and neck squamous cell carcinoma. If patients have received prior combined modality
therapy, they must be off therapy for at least 6 months.
4. Be >= 18 years of age.
5. No acute intercurrent illness or infection.
6. ECOG performance status =<2 (Karnofsky =>60%). Have normal organ and marrow function
defined as: leukocytes=>3,000/uL; absolute neutrophil count=>1,500/uL; platelets
=>100,000/uL hemoglobin >= 8g/dl; total bilirubin within normal institutional limits;
AST(SGOT)/ALT(SGPT) =<2.5 X institutional upper limit of normal if alkaline phosphate
|Official title||A Phase II Study of OSI-774 in Combination With Cisplatin and Docetaxel in Metastatic or Recurrent Head and Neck Squamous Cell Cancer|
|Principal investigator||William N. William Jr., MD|
|Description||OSI-774 is a drug that helps to block the activity of an enzyme that is believed to play an important role in cell growth. It is hoped that blocking these enzymes will slow tumor growth. Both cisplatin and docetaxel are commonly used chemotherapy drugs. These drugs are designed to target and destroy cancer cells. Before the study, you will have a physical exam, blood tests (around 2 teaspoons), and an electrocardiogram (ECG - a test that measures the electrical activity of the heart). You will also have a chest x-ray and a CT scan. If the diagnosis has not yet been confirmed, a biopsy of the tumor may need to be done. Women who are able to have children must have a negative blood or urine pregnancy test. During treatment, you will take OSI-774 by mouth once a day. Once every 3 weeks, you will be given docetaxel and cisplatin. Docetaxel is given by a continuous infusion into a vein over 1 hour. This will be followed by an infusion into a vein of cisplatin over 2 hours. Treatment with docetaxel and cisplatin is given every 3 weeks for 18 weeks. You will continue to take OSI-774 until your disease worsens, until side effects become too severe, or until your doctor thinks it is no longer benefiting you. If at any time during the study the disease becomes worse or you experience any intolerable side effects, you will be taken off the study and your doctor will discuss other treatment options with you. During the study, you will have blood drawn (around 2 teaspoons) once a week. These samples will be used for routine lab tests. Every 3 weeks, you will have a physical exam and your vital signs and weight will be measured. You will also be asked about any side effects you may be experiencing. If your doctor feels it is necessary, you may have more frequent check-up visits. Every 6 weeks during treatment, you will have blood tests (around 2 teaspoons), and imaging tests. The imaging tests include a chest x-ray and a CT scan of the head and neck area. You may also have CT scans of other areas of the body. These tests are being done to check on the status of the disease. You may continue receiving OSI-774 for as long as your cancer responds to study treatment. If you continue to receive OSI-774, every 3 months you will have a physical exam (including measurement of vital signs), routine blood tests (about 2 teaspoons), a performance status test (a test looking at the ability to perform everyday activities), a chest x-ray, and a CT or MRI scan. Your doctor may decide to take you off this study if you experience significant side effects or your medical condition worsens. This is an investigational study. OSI-774 is approved by the FDA for treatment of NSCLC in patients who have relapsed. Its use in this study is considered investigational. Docetaxel and cisplatin are FDA approved and commercially available. There will be a total of 50 patients taking part in this study.|
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