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Sponsors and Collaborators: |
University of Alabama at Birmingham Genentech |
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Information provided by: | University of Alabama at Birmingham |
ClinicalTrials.gov Identifier: | NCT00655850 |
This study is being done to determine the overall progression-free survival (PFS) in patients with advanced or metastatic (Stage IIIB - pleural effusion/IV), non-squamous histology NSCLC treated with metronomic chemotherapy plus Avastin. Also, currently there are no defined markers that predict for clinical benefit to Avastin. Preliminary studies show that there are several observations that support the concept of metronomic chemotherapy with or without the combination of an anti-angiogenic agent. The metronomic chemotherapy with Avastin was shown to enhance the clinical endpoints of the study (response rate and progressive-free survival). Proof of metronomic scheduling requires the development of appropriate intermediate surrogate markers. Several markers will be assessed.
Condition | Intervention | Phase |
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Non-Small Cell Lung Cancer |
Drug: Paclitaxel Drug: Gemcitabine Biological: Avastin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study |
Official Title: | Pilot Phase II Study of Metronomic Chemotherapy in Combination With Avastin in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer |
Estimated Enrollment: | 35 |
Study Start Date: | March 2008 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: Paclitaxel
Paclitaxel Dose Levels:
Premedication
Gemcitabine Dose Levels:
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This is a non-randomized, open-label, pilot Phase II study of metronomic chemotherapy plus Avastin in chemo naïve subjects with advanced non-squamous, non-small cell carcinoma of the lung. The primary endpoint of this study is to assess the overall progression-free survival.
Subjects will be treated with metronomic chemotherapy with paclitaxel and gemcitabine weekly for 3 out of 4 weeks, and Avastin will be administered every 2 weeks. Treatment with metronomic chemotherapy will be expressed as a 4-week cycle. Tumor response to treatment will be evaluated every 8 weeks.
Treatment with metronomic chemotherapy and Avastin will continue for a total of 6 cycles unless there is evidence of disease progression, intolerable toxicity, or withdrawal of consent. Maintenance therapy with Avastin will then continue until disease progression, intolerable toxicity or withdrawal of consent.
Potential biologic parameters to monitor anti-tumor activity of metronomic chemotherapy will be evaluated in 10 subjects. These biomarkers include: sequential determination of blood levels of VEGF, VEGFR2, thrombespondin-1, E-selectin, ICAM-1, and circulating endothelial cells and endothelial precursor cells.
Ages Eligible for Study: | 19 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Neutrophil Count greater than or equal to 1500/μL
INR ≤ 1.5 and a PTT no greater than the ULN
Exclusion Criteria
Avastin-Specific Exclusions
Contact: Francisco Robert, M.D. | (205) 934-5077 | francisco.robert@ccc.uab.edu |
United States, Alabama | |
University of Alabama at Birmingham | Recruiting |
Birmingham, Alabama, United States, 35294 - 0104 | |
Principal Investigator: Francisco Robert, M.D. |
Principal Investigator: | Francisco Robert, M.D. | University of Alabama at Birmingham |
Responsible Party: | University of Alabama at Birmingham ( Francisco Robert, M.D. ) |
Study ID Numbers: | F070727010, UAB 0709 |
Study First Received: | April 4, 2008 |
Last Updated: | April 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00655850 |
Health Authority: | United States: Institutional Review Board |
Lung Cancer Non-Small Cell Lung Cancer Metronomic Chemotherapy |
Thoracic Neoplasms Dexamethasone Non-small cell lung cancer Bevacizumab Serotonin Carcinoma Ranitidine Promethazine Ranitidine bismuth citrate |
Respiratory Tract Diseases Lung Neoplasms Paclitaxel Lung Diseases Gemcitabine Carcinoma, Non-Small-Cell Lung Diphenhydramine Dexamethasone acetate Neoplasms, Glandular and Epithelial |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Neoplasms by Site Therapeutic Uses Angiogenesis Modulating Agents Growth Inhibitors Respiratory Tract Neoplasms Neoplasms by Histologic Type |
Growth Substances Mitosis Modulators Enzyme Inhibitors Antimitotic Agents Antiviral Agents Immunosuppressive Agents Angiogenesis Inhibitors Pharmacologic Actions Neoplasms Radiation-Sensitizing Agents Tubulin Modulators Antineoplastic Agents, Phytogenic |