OSI-774/Cisplatin/Taxotere in Head & Neck Squamous Cell Cancer
|Head and Neck Cancer||Drug: Docetaxel Drug: OSI-774 Drug: Cisplatin||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|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|
- Response Rate [ Time Frame: Every 6-8 weeks ]Primary endpoint is determination of the response rate and efficacy of combination therapy (OSI-774, cisplatin, and docetaxel). Response rate defined as percentage of number of complete response or partial response in total number of patients treated.
- 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. ]Secondary endpoints include safety, toxicity profile and evaluation of time to progression. Safety and toxicity profiles evaluated by NCI Common Terminology Criteria for Adverse Events v3.0.
|Actual Study Start Date:||January 2004|
|Estimated Study Completion Date:||January 2019|
|Estimated Primary Completion Date:||January 2019 (Final data collection date for primary outcome measure)|
Experimental: Cisplatin + Docetaxel + OSI-774
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.
60 mg/m^2 IV repeated every 21 days.
Other Name: TaxotereDrug: 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.
Other Names:Drug: Cisplatin
75 mg/m^2 IV every 21 days.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00076310
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Maura Gillison, MD||M.D. Anderson Cancer Center|