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ZD1839 Plus Chemotherapy in Treating Patients With Non-Small Cell Lung Cancer Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on ZD1839 Plus Chemotherapy in Treating Patients With Non-Small Cell Lung Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. ZD1839 Plus Chemotherapy in Treating Patients With Non-Small Cell Lung Cancer Clinical research trials and ZD1839 Plus Chemotherapy in Treating Patients With Non-Small Cell Lung Cancer healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including ZD1839 Plus Chemotherapy in Treating Patients With Non-Small Cell Lung Cancer. ZD1839 Plus Chemotherapy in Treating Patients With Non-Small Cell Lung Cancer Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a ZD1839 Plus Chemotherapy in Treating Patients With Non-Small Cell Lung Cancer clinical trial. Test subjects oftentimes recieve the best healthcare possible for their ZD1839 Plus Chemotherapy in Treating Patients With Non-Small Cell Lung Cancer condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "Z" Clinical Trials Conditions > ZD1839 Plus Chemotherapy in Treating Patients With Non-Small Cell Lung Cancer  ZD1839 Plus Chemotherapy in Treating Patients With Non-Small Cell Lung Cancer
ZD1839 Plus Chemotherapy in Treating Patients With Non-Small Cell Lung Cancer
For Condition: stage 4 non-small cell lung cancer,Quality of Life,recurrent non-small cell lung cancer,stage 3B non-small cell lung cancer
Status: No longer recruiting
Sponsor(s): AstraZeneca ,
Synopsis: RATIONALE: Some tumors need growth factors produced by the body's white blood cells to keep growing. ZD1839 may interfere with the growth factor and stop the tumor from growing. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether combination chemotherapy is more effective with or without ZD1839 for non-small cell lung cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without ZD1839 in treating patients who have stage III or stage IV non-small cell lung cancer.
Details: OBJECTIVES: I. Compare the 1 year survival rate, time to worsening of disease related symptoms, and progression free survival in chemotherapy naive patients with stage IIIB or IV non-small cell lung cancer treated with one of two doses of ZD 1839 or placebo combined with paclitaxel and carboplatin. II. Compare the quality of life of patients treated with these three regimens. PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study. Patients are randomized to one of three treatment arms. All patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 15-30 minutes on day 1. Patients receive lower dose oral ZD 1839 (arm I), higher dose oral ZD 1839 (arm II), or placebo (arm III) twice on day 1, and then once daily thereafter. Chemotherapy repeats every 3 weeks for a maximum of 6 courses. ZD 1839 or placebo continues daily in the absence of disease progression or unacceptable toxicity. Quality of life is assessed prior to study, then every 3 weeks until completion of chemotherapy, then every 4 weeks until completion of oral ZD 1839 or placebo, and then every 8 weeks thereafter. Patients are followed every 8 weeks. PROJECTED ACCRUAL: A total of 1,029 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically proven non-small cell lung cancer; Stage III disease that is not curable with surgery or radiotherapy OR Stage IV disease - Chemotherapy naive --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: See Disease Characteristics - Endocrine therapy: No concurrent therapy that may interfere with evaluation of response - Radiotherapy: See Disease Characteristics; Prior localized irradiation allowed - Surgery: See Disease Characteristics; Prior surgery allowed - Other: No concurrent drugs with known significant cytochrome P450 3A4 inhibitory effects (e.g., ketoconazole, itraconazole, troleandomycin, erythromycin, diltiazem, verapamil); No concurrent use of contact lenses --Patient Characteristics-- - Age: 18 and over - Performance status: 0-2 - Life expectancy: Not specified - Hematopoietic: Absolute neutrophil count at least 2,000/mm3; WBC at least 4,000/mm3; Platelet count at least 100,000/mm3 - Hepatic: ALT or AST no greater than 2.5 times upper limit of normal (ULN) (no greater than 5 times ULN if liver metastasis present) - Renal: Creatinine no greater than 1.5 times ULN - Cardiovascular: No evidence of severe or uncontrolled cardiovascular disease - Pulmonary: No evidence of severe or uncontrolled pulmonary disease - Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
Patient(In the US & Canada) AstraZeneca Pharmaceuticals LP, Study Chair, AstraZeneca
AstraZeneca Pharmaceuticals LP
Wilmington, Delaware, 19850-5437
United States
Additional Information:
Study ID Numbers: CDR0000068065; MSKCC-00100,ZENECA-1839IL/0017
Study Start Date: May 2000
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006049
Other Quality Of Life Studies:
1. Pentosan Polysulfate in Treating Patients With Gastrointestinal Disturbance Caused by Radiation Therapy
2. Stress Management Training in Patients Undergoing Radiation Therapy for Cancer
3. Group Therapy Compared With Educational Materials in Patients With Prostate Cancer
4. Donepezil and Vitamin E to Prevent Side Effects Caused By Radiation Therapy to the Head in Patients Receiving Treatment for Small Cell Lung Cancer
5. Chemotherapy With or Without Wobe-Mugos E in Treating Patients With Stage II or Stage III Multiple Myeloma
Related Studies:
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ZD1839 Plus Chemotherapy in Treating Patients With Non-Small Cell Lung Cancer
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