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Sponsors and Collaborators: |
University of Medicine and Dentistry New Jersey Eastern Cooperative Oncology Group |
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Information provided by: | University of Medicine and Dentistry New Jersey |
ClinicalTrials.gov Identifier: | NCT00695760 |
This purpose of this study is to compare the effects (good and bad) of chemotherapy (docetaxel) plus ZD1839 (Iressa, gefitinib) with docetaxel and placebo on the head and neck cancer to see which is better. No study has yet compared ZD1839 (Iressa, gefitinib) and docetaxel in head and neck cancer. It is possible that the addition of ZD1839 (Iressa, gefitinib) to docetaxel in head and neck cancers. It is possible that the addition of ZD1839 (Iressa, gefitinib) to docetaxel will be more effective than docetaxel alone.
"ZD1839 (Iressa, gefitinib) is a new investigational drug treatment that has been shown to slow or stop growth in tumors. In clinical trials, ZD1839 (Iressa, gefitinib) has been able to shrink head and neck cancer tumors but in a small percentage of patients. A clinical trial that compared ZD1839 (Iressa, gefitinib) with methotrexate, a standard chemotherapy in head and neck cancer, showed that ZD1839 (Iressa, gefitinib) was not better than methotrexate. However, it is possible that adding ZD1839 (Iressa, gefitinib) to chemotherapy drugs will benefit patients with head and neck cancer. ZD1839 (Iressa, gefitinib) works differently from the way chemotherapy drugs work. Chemotherapy usually targets the cell's DNA and may affect both normal and cancer cells. ZD1839 (Iressa, gefitinib) targets a protein that is on the outside of cancer cells. The protein helps cancer cells to spread and grow. ZD1839 (Iressa, gefitinib) attaches to this protein and "switches it off" so that the cancer cells stop growing."
Condition | Intervention | Phase |
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Head and Neck Cancer |
Drug: docetaxel OR placebo Drug: docetaxel OR gefitinib |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase III Randomized, Placebo Controlled, Trial Of Docetaxel Versus Docetaxel Plus ZD1839 (Iressa, Gefitinib, NSC 715055) In Performance Status 2 Or Previously Treated Patients With Recurrent Or Metastatic Head And Neck Cancer |
Estimated Enrollment: | 330 |
Study Start Date: | August 2004 |
Estimated Primary Completion Date: | January 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm I: Active Comparator
Patients receive docetaxel IV over 30-60 minutes on days 1, 8, and 15 and oral placebo once daily on days 1-28.
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Drug: docetaxel OR placebo
Docetaxel will be given IV over 30-60 minutes Placebo will be given orally
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Arm II: Experimental
Patients receive docetaxel as in arm I and oral gefitinib once daily on days 1-28.
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Drug: docetaxel OR gefitinib
Docetaxel will be given IV over 30-60 minutes Gefitinib will be given orally
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Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, New Jersey | |
University of Medicine and Dentistry of New Jersey | Recruiting |
Newark, New Jersey, United States, 07101 | |
Contact: Yasmeen S Barber, BA 973-972-7789 barberys@umdnj.edu | |
Principal Investigator: Lillian Pliner, MD | |
Sub-Investigator: Margarette R Bryan, MD | |
Sub-Investigator: Meera Hameed, MD | |
Sub-Investigator: Mark Levin, MD |
Responsible Party: | University of Pittsburgh-Dept of Medicine-Hematology/Oncology AND Eastern Cooperative Oncology Group ( Athanassios Argiris, M.D., FACP, Study Chair ) |
Study ID Numbers: | 0120050012 |
Study First Received: | June 9, 2008 |
Last Updated: | June 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00695760 |
Health Authority: | United States: Food and Drug Administration |
Docetaxel Head and Neck Neoplasms Gefitinib Recurrence |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |