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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborators: |
AstraZeneca Aventis Pharmaceuticals |
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00048087 |
Purpose
Patients will receive 250 mg Iressa by mouth daily each day while on this study. Patients will also receive docetaxel 30 mg/m2 by by vein (IV) on day 1 weekly for the first 3 weeks of each course of therapy. A course of therapy is 4 weeks. Patients will not receive docetaxel during week 4. A maximum of 8 full cycles of docetaxel plus Iressa are planned. Patients may continue on daily Iressa until progressive disease and/or unacceptable toxicity.
| Condition | Intervention | Phase |
|---|---|---|
|
Non-small Cell Lung Cancer |
Drug: ZD1839 Drug: Docetaxel |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study of ZD1839 (Iressa), Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor, in Combination With Docetaxel in Patients With Recurrent or Metastatic Advanced Non-Small Cell Lung Cancer |
| Enrollment: | 0 |
| Study Start Date: | August 2002 |
| Study Completion Date: | July 2003 |
| Primary Completion Date: | July 2003 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Iressa + Docetaxel |
Drug: ZD1839
250 mg by mouth daily each day for 4 weeks.
Other Names:
Drug: Docetaxel
30 mg/m2 by IV on day 1 weekly for the first 3 weeks of each 4 week course.
Other Name: Taxotere
|
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Texas | |
| UT MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Edward S. Kim, MD, BS | UT MD Anderson Cancer Center |
More Information
| Responsible Party: | Edward S. Kim, MD, BS / Associate Professor, UT MD Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00048087 History of Changes |
| Other Study ID Numbers: | ID02-004 |
| Study First Received: | October 24, 2002 |
| Last Updated: | October 25, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
Non-small cell lung cancer |
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases |
Respiratory Tract Diseases Docetaxel Gefitinib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |