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Trial of ABI-007 Administered Weekly in Chemotherapy Naive Patients with Advanced Non-Small Cell Lung Cancer Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about Trial of ABI-007 Administered Weekly in Chemotherapy Naive Patients with Advanced Non-Small Cell Lung Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Trial of ABI-007 Administered Weekly in Chemotherapy Naive Patients with Advanced Non-Small Cell Lung Cancer Clinical research trials and Trial of ABI-007 Administered Weekly in Chemotherapy Naive Patients with Advanced Non-Small Cell Lung Cancer health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like Trial of ABI-007 Administered Weekly in Chemotherapy Naive Patients with Advanced Non-Small Cell Lung Cancer. Trial of ABI-007 Administered Weekly in Chemotherapy Naive Patients with Advanced Non-Small Cell Lung Cancer Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a Trial of ABI-007 Administered Weekly in Chemotherapy Naive Patients with Advanced Non-Small Cell Lung Cancer clinical trial. Subjects frequently get the best healthcare possible for their Trial of ABI-007 Administered Weekly in Chemotherapy Naive Patients with Advanced Non-Small Cell Lung Cancer condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.
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Home > "T" Clinical Trials Conditions > Trial of ABI-007 Administered Weekly in Chemotherapy Naive Patients with Advanced Non-Small Cell Lung Cancer  Trial of ABI-007 Administered Weekly in Chemotherapy Naive Patients with Advanced Non-Small Cell Lung Cancer
Trial of ABI-007 Administered Weekly in Chemotherapy Naive Patients with Advanced Non-Small Cell Lung Cancer
For Condition: Non-small cell lung cancer
Status: Recruiting
Sponsor(s): American Bioscience ,
Synopsis: The anticancer agent paclitaxel (Taxol for Injection Concentrate, Bristol-Meyers Squibb) has a broad spectrum of activity against several human cancers including carcinomas of ovary, breast, lung, esophagus and head and neck cancer. Taxol has shown remarkable activity against metastatic breast cancer, yielding response rates in the range of 40% to 60% in chemotherapy-naive patients and 25%-30% in patients refractory to anthracycline-containing regimens (Taxol package insert). The major limitation of Taxol is its poor water soluability requiring Cremophor (containing castor oil and ethanol) as a solvent. Taxol in this vehicle must be administered over 3-24 hours, and hypersensitivity reactions to Cremophor require a premedication routine of a corticosteroid, an antihistamine, and an H2 antagonist.
Details: ABI-007, a unique protein formulation of paclitaxel, has been developed to reduce the toxicities associated with Taxol and Cremophor EL/ethanol vehicle while maintaining or improving the chemotherapeutic effect of the drug. The activity of ABI-007 in other malignancies is not yet well established. This open-label Phase I/II study is being conducted to define the maximum tolerated dose (MTD) and dose-limiting toxicities (DLT) of ABI-007, and evaluate the safety and antitumor activity of ABI-007 in patients with advanced Stage IV non-small cell lung cancer (NSCLC).
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: Patients must be: - Histologically or cytologically confirmed advanced stage IV NSCLC with evidence of inoperable local recurrence or metastasis - If female, non-pregnant and not lactating, with a negative serum pregnancy test, and either not of child-bearing potential or practicing an approved contraception method - Eighteen years of age or older - No other current active malignancy - Measurable disease (defined by RECIST criteria) documented radiographically - Patient must have received no prior chemotherapies for the treatment of metastatic disease. Radiation therapy to a major bone marrow-containing area must have been completed 3 or more weeks prior to study entry. Prior treatment with EGF-targeted therapies is permitted. - If, at baseline, patient has ANC greater than or equal to 1.5 x 109 cells/L; platelets greater than or equal to 100 x 109 cells/L and Hgb greater than or equal to 9 g/dL - If, at baseline, patient has AST and ALT of less than or equal to 2.5 x the upper limit of normal range; a total bilirubin NORMAL; creatinine levels less than or equal to 1.5 mg/dL and alkaline phosphatase levels less than or equal to 2.5 x the upper limit of normal range (unless alkaline phosphatase elevation is felt to be related to bone metastases and there is no radiologic eveidence of hepatic metastasis) - Expected survival of greater than 12 weeks - ECOG performance status 0-1 (Karnofsky > 70) - Patient or his/her legally authorized representative or guardian has been informed about the nature of the study, and has agreed to participate in the study, and signed the Informed Consent form prior to participation in any study-related activities.
Total Enrollment: 64
Location and Contact Information:
Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City, New York, 10021
United States
Recruiting Naiyer Rizvi
Additional Information:
Study ID Numbers: CA015-0;
Study Start Date: December 2003
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00073723
Other Non-Small Cell Lung Cancer Studies:
1. Helical Computed Tomography Compared With Chest X-Ray in Screening Individuals at High Risk for Lung Cancer
2. Tarceva Surgery for Resectable Stage IIIA(N2) Non-Small-Cell Lung Cancer
3. Safety and Immunogenicity of Recombinant DNA and Adenovirus Expressing L523S Protein in Early Stage Non-Small Cell Lung Cancer
4. National Lung Screening Trial (NLST)
5. Docetaxel With or Without Exisulind in Treating Patients With Non-Small Cell Lung Cancer
Related Studies:
Other Non-small cell lung cancer Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Trial of ABI-007 Administered Weekly in Chemotherapy Naive Patients with Advanced Non-Small Cell Lung Cancer
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