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A Double-Blind, Randomized, Placebo-Controlled, Multicenter, Phase III Study of Tariquidar + Paclitaxel/Carboplatin as First-Line Therapy in Non-Small Cell Lung Cancer (NSCLC) Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on A Double-Blind, Randomized, Placebo-Controlled, Multicenter, Phase III Study of Tariquidar + Paclitaxel/Carboplatin as First-Line Therapy in Non-Small Cell Lung Cancer (NSCLC) conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. A Double-Blind, Randomized, Placebo-Controlled, Multicenter, Phase III Study of Tariquidar + Paclitaxel/Carboplatin as First-Line Therapy in Non-Small Cell Lung Cancer (NSCLC) Clinical research trials and A Double-Blind, Randomized, Placebo-Controlled, Multicenter, Phase III Study of Tariquidar + Paclitaxel/Carboplatin as First-Line Therapy in Non-Small Cell Lung Cancer (NSCLC) healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including A Double-Blind, Randomized, Placebo-Controlled, Multicenter, Phase III Study of Tariquidar + Paclitaxel/Carboplatin as First-Line Therapy in Non-Small Cell Lung Cancer (NSCLC). A Double-Blind, Randomized, Placebo-Controlled, Multicenter, Phase III Study of Tariquidar + Paclitaxel/Carboplatin as First-Line Therapy in Non-Small Cell Lung Cancer (NSCLC) Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a A Double-Blind, Randomized, Placebo-Controlled, Multicenter, Phase III Study of Tariquidar + Paclitaxel/Carboplatin as First-Line Therapy in Non-Small Cell Lung Cancer (NSCLC) clinical trial. Test subjects typically receive the most effective healthcare possible for their A Double-Blind, Randomized, Placebo-Controlled, Multicenter, Phase III Study of Tariquidar + Paclitaxel/Carboplatin as First-Line Therapy in Non-Small Cell Lung Cancer (NSCLC) condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health 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 > "A" Clinical Trials Conditions > A Double-Blind, Randomized, Placebo-Controlled, Multicenter, Phase III Study of Tariquidar + Paclitaxel/Carboplatin as First-Line Therapy in Non-Small Cell Lung Cancer (NSCLC)  A Double-Blind, Randomized, Placebo-Controlled, Multicenter, Phase III Study of Tariquidar + Paclitaxel/Carboplatin as First-Line Therapy in Non-Small Cell Lung Cancer (NSCLC)
A Double-Blind, Randomized, Placebo-Controlled, Multicenter, Phase III Study of Tariquidar + Paclitaxel/Carboplatin as First-Line Therapy in Non-Small Cell Lung Cancer (NSCLC)
For Condition: Stage 4 non-small cell lung cancer,Stage IIIb non-small cell lung cancer
Status: Terminated
Sponsor(s): QLT Inc ,
Synopsis: To determine whether tariquidar + combined first-line chemotherapy of paclitaxel/carboplatin in patients with Stage IIIb/IV NSCLC will, with an acceptable safety profile, significantly improve overall survival compared with placebo + paclitaxel/carboplatin. To compare the effects of tariquidar/paclitaxel/carboplatin with placebo/paclitaxel/carboplatin on tumor response, time to disease progression, performance status, symptom progression, and quality of life in patients with Stage IIIb/IV NSCLC.
Details:
Eligibility:
Study Type: Interventional, Randomized, Double-Blind, Placebo Control
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: 1. Patients who have histologically or cytologically proven NSCLC, stage IIIb or stage IV, requiring first-line chemotherapy. 2. Patients who have a WHO performance status of 1 or 0 and life expectancy of greater than 3 months. 3. Patients who are 18 years of age or older and age of consent. 4. Patients who are women of child-bearing potential must not be pregnant or lactating, must have a negative pregnancy test (serum or urine) at screening, and must be practicing an adequate method of birth control. 5. Patients who have neutrophils greater or equal to 1.5 x 103/µL; platelets greater or equal to 100 x 103/µL; bilirubin less or equal to 1.5 times the upper limit of normal or less or equal to 26 µmol/L (1.5 mg/dL); transaminases less or equal to 2.5 times the upper limit of normal or, for patients with known liver metastases, less or equal to 5 times the upper limit of normal; and creatinine less or equal to 141 µmol/L (1.6 mg/dL) or calculated creatinine clearance greater or equal to 60 mL/min prior to study treatment. 6. Patients who are able to give written informed consent and comply with the protocol. Exclusion Criteria: 1. Patients who are eligible for radiotherapy or surgery for curative intent. 2. Patients who have had previous chemotherapy for NSCLC. 3. Patients who have a WHO performance status greater than 1. 4. Patients with bronchoalveolar carcinoma (an adenocarcinoma in which cylindrical tumor cells grow upon the walls of pre-existing alveoli, from WHO histological typing of lung tumors [1]). 5. Patients who have previous or current primary malignancies at other sites within the last 5 years, with the exception of adequately treated cone-biopsied carcinoma of the cervix and basal or squamous cell skin carcinoma. 6. Patients who are a poor medical risk because of other nonmalignant systemic diseases or active uncontrolled infections. 7. Patients who have symptomatic brain metastases. 8. Patients who have peripheral neuropathy of CTC grade 2, 3, or 4. 9. Patients who have other medical or surgical conditions that would contraindicate chemotherapy. 10. Patients who have received experimental therapies within the last 4 weeks. 11. Patients who have known hypervitaminosis or known sensitivity to ascorbic acid, vitamin A, vitamin D, thiamine, riboflavin, pyridoxine, niacinamide, d-panthenol, or vitamin E.
Total Enrollment: 540
Location and Contact Information:
Additional Information:
Study ID Numbers: TQD LUNG 001;
Study Start Date: June 2002
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00042302
Other Stage Iiib Non-Small Cell Lung Cancer Studies:
1. A Double-Blind, Randomized, Placebo-Controlled, Multicenter, Phase III Study of Tariquidar + Paclitaxel/Carboplatin as First-Line Therapy in Non-Small Cell Lung Cancer (NSCLC)
2. A Double-Blind, Randomized, Placebo-Controlled, Multicenter, Phase III Study of Tariquidar + Vinorelbine as First-Line Therapy in Non-Small Cell Lung Cancer (NSCLC)
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A Double-Blind, Randomized, Placebo-Controlled, Multicenter, Phase III Study of Tariquidar + Paclitaxel/Carboplatin as First-Line Therapy in Non-Small Cell Lung Cancer (NSCLC)
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