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Study of PT-100 and Docetaxel in Advanced Non-Small Cell Lung Cancer Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about Study of PT-100 and Docetaxel in Advanced Non-Small Cell Lung Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Study of PT-100 and Docetaxel in Advanced Non-Small Cell Lung Cancer Clinical research trials and Study of PT-100 and Docetaxel in Advanced Non-Small Cell Lung Cancer health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including Study of PT-100 and Docetaxel in Advanced Non-Small Cell Lung Cancer. Study of PT-100 and Docetaxel in Advanced Non-Small Cell Lung Cancer Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Study of PT-100 and Docetaxel in Advanced Non-Small Cell Lung Cancer clinical trial. Test subjects typically receive the most expert healthcare available for their Study of PT-100 and Docetaxel in Advanced Non-Small Cell Lung Cancer condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "S" Clinical Trials Conditions > Study of PT-100 and Docetaxel in Advanced Non-Small Cell Lung Cancer  Study of PT-100 and Docetaxel in Advanced Non-Small Cell Lung Cancer
Study of PT-100 and Docetaxel in Advanced Non-Small Cell Lung Cancer
For Condition: Lung Cancer
Status: Recruiting
Sponsor(s): Point Therapeutics ,
Synopsis: The purpose of this study is to determine the antitumor activity (response rate, time to tumor progression, survival) and safety of docetaxel in combination with PT-100 in patients with advanced non-small cell lung cancer (NSCLC) who have failed a prior platinum-containing regimen.
Details:
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Histologically or cytologically confirmed Stage IIIb/IV NSCLC - Failed or relapsed after receiving a platinum-containing chemotherapy regimen as first-line therapy for advanced NSCLC - Measurable disease - ECOG Performance Status of 0 or 1 - Expected survival 12 weeks - Provide written informed consent Exclusion Criteria: - More than 2 prior chemotherapy regimens - Brain metastases (exception: patients who have had a resection and/or completed a course of cranial irradiation, have no worsening CNS symptoms, and have discontinued all corticosteroids for that indication for at least 1 month) - Any malignancy within the 5 years immediately prior to the first dose of study medication with the exception of basal cell or non-metastatic squamous cell carcinoma of the skin, and carcinoma in-situ of the cervix - The need for chronic (i.e., >7 days) oral or intravenous corticosteroid therapy - A history of severe hypersensitivity reactions to drugs formulated with polysorbate 80 - A history of myocardial infarction within 1 year of study entry, CABG within 6 months of study entry, severe congestive heart failure (ejection fraction <30%), history of ventricular arrhythmia, or other uncontrolled cardiac arrhythmia - Any comorbidity or condition which, in the opinion of the investigator, may interfere with the assessments and procedures of this protocol - Patients who are within 30 days of chemotherapy, radiation therapy, immunotherapy, or other investigational medication for NSCLC. Patients must have recovered from all of the side effects of treatment in order to be enrolled. - Pregnant or lactating women. - Clinically significant laboratory abnormalities, specifically: Total bilirubin institutional upper limit of normal (ULN); Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) 1.5 x ULN concomitant with alkaline phosphatase >2.5 x ULN; Hepatitis B surface antigen or antibody to Hepatitis C (anti-HCV antibody); Serum creatinine 2.0mg/dL; or Granulocytes <1500/μL or platelets <100,000/μL.
Total Enrollment:
Location and Contact Information:
New York Oncology/Hematology--Albany Regional Cancer Center *Recruiting*
Albany, New York, 12208
United States
Recruiting
Tyler Cancer Center *Recruiting*
Tyler, Texas, 75702
United States
Recruiting
Mary Crowley Medical Research Center *Recruiting*
Dallas, Texas, 75246
United States
Recruiting
Dayton Oncology & Hematology *Recruiting*
Kettering, Ohio, 45409
United States
Recruiting
Van Elslander Cancer Center *Not yet recruiting*
Grosse Pointe, Michigan, 48236
United States
Not yet recruiting
University of Chicago *Not yet recruiting*
Chicago, Illinois, 60637
United States
Not yet recruiting
Additional Information:
Study ID Numbers: PTH-302;
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00080080
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3. Study of Inhaled Doxorubicin (Adriamycin) to Treat Advanced Lung Cancer
4. Study of S-3304 in Patients with Locally Advanced Non-Small Cell Lung Cancer
5. Amifostine Followed by High Dose Chemotherapy in Treating Patients With Hematologic Cancer or Solid Tumors
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Study of PT-100 and Docetaxel in Advanced Non-Small Cell Lung Cancer
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