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Tracking Information | |
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First Received Date † | June 9, 2008 |
Last Updated Date | June 9, 2008 |
Start Date † | August 2004 |
Current Primary Outcome Measures † |
Overall survival [ Time Frame: Patients are followed every 3 months for 2 years and then every 6 months for 3 years. ] [ Designated as safety issue: No ] |
Original Primary Outcome Measures † | Same as current |
Change History | No Changes Posted |
Current Secondary Outcome Measures † |
Time to progression [ Time Frame: Patients are followed every 3 months for 2 years and then every 6 months for 3 years. ] [ Designated as safety issue: No ] |
Original Secondary Outcome Measures † | Same as current |
Descriptive Information | |
Brief Title † | Docetaxel With or Without Gefitinib in Treating Patients With Metastatic or Locally Recurrent Head and Neck Cancer |
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 |
Brief Summary | 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." |
Detailed Description | |
Study Phase | Phase III |
Study Type † | Interventional |
Study Design † | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Condition † | Head and Neck Cancer |
Intervention † |
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Study Arms / Comparison Groups |
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Publications * | |
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |
Recruitment Status † | Recruiting |
Enrollment † | 330 |
Completion Date | |
Estimated Primary Completion Date | January 2007 (final data collection date for primary outcome measure) |
Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Cardiovascular
Other
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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Gender | Both |
Ages | 18 Years to 80 Years |
Accepts Healthy Volunteers | No |
Contacts †† | |
Location Countries † | United States |
Expanded Access Status | |
Administrative Information | |
NCT ID † | NCT00695760 |
Responsible Party | Athanassios Argiris, M.D., FACP, Study Chair, University of Pittsburgh-Dept of Medicine-Hematology/Oncology AND Eastern Cooperative Oncology Group |
Secondary IDs †† | |
Study Sponsor † | University of Medicine and Dentistry New Jersey |
Collaborators †† | Eastern Cooperative Oncology Group |
Investigators † | |
Information Provided By | University of Medicine and Dentistry New Jersey |
Verification Date | June 2008 |
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |