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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00313768 |
To assess the efficacy and safety of PF-3512676 administered in combination with paclitaxel, carboplatin and bevacizumab as first-line treatment in patients with locally advanced or metastatic nonsquamous non-small cell lung cancer
Condition | Intervention | Phase |
---|---|---|
Carcinoma, Non-Small-Cell Lung |
Drug: paclitaxel + carboplatin + bevacizumab Drug: carboplatin + paclitaxel + bevacizumab + PF-3512676 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized Phase 2 Trial Of Paclitaxel, Carboplatin And Bevacizumab With Or Without PF-3512676 As First-Line Treatment Of Patients With Advanced Nonsquamous Non-Small Cell Lung Cancer |
Enrollment: | 23 |
Study Start Date: | December 2005 |
Study Completion Date: | May 2008 |
Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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B: Active Comparator
Standard of care chemotherapy
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Drug: paclitaxel + carboplatin + bevacizumab
paclitaxel 200 mg/m2 intravenously Day 1 of each 21 day cycle x 6 cycles
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A: Experimental
Standard of care chemotherapy plus experimental intervention (PF-3512676)
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Drug: carboplatin + paclitaxel + bevacizumab + PF-3512676
carboplatin AUC 6 intravenously on Day 1 of each 21 day cycle x 6 cycles
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PF-3512676 dosing was stopped 21 June 2007 when Pfizer decided to stop the administration of PF-3512676 in all trials which combined PF-3512676 with cytotoxic chemotherapy. the decision was made subsequent to DSMC recommendation to close two phase III randomized trials in non-small cell lung cancer which also combined PF-3512676 with cytotoxic chemotherapy, citing lack of efficacy concerns as the primary reason with safety issues (sepsis, thrombocytopenia) also contributing to the decision. Subjects were allowed to complete standard of care treatment/survival follow-up. Data collection was completed on 22 May 2008.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Alabama | |
Pfizer Investigational Site | |
Bessemer, Alabama, United States, 35022 | |
Pfizer Investigational Site | |
Birmingham, Alabama, United States, 32511 | |
Pfizer Investigational Site | |
Birmingham, Alabama, United States, 35205 | |
Pfizer Investigational Site | |
Mobile, Alabama, United States, 36607 | |
Pfizer Investigational Site | |
Birmingham, Alabama, United States, 35213 | |
Pfizer Investigational Site | |
Birmingham, Alabama, United States, 35235 | |
Pfizer Investigational Site | |
Birmingham, Alabama, United States, 35209 | |
United States, California | |
Pfizer Investigational Site | |
Los Angeles, California, United States, 90033 | |
Pfizer Investigational Site | |
Fountain Valley, California, United States, 92708 | |
United States, Florida | |
Pfizer Investigational Site | |
Cocoa Beach, Florida, United States, 32931 | |
Pfizer Investigational Site | |
Merritt Island, Florida, United States, 32952 | |
Pfizer Investigational Site | |
Rockledge, Florida, United States, 32955 | |
Pfizer Investigational Site | |
Titusville, Florida, United States, 32796 | |
United States, Georgia | |
Pfizer Investigational Site | |
Valdosta, Georgia, United States, 31602 | |
United States, Illinois | |
Pfizer Investigational Site | |
Joliet, Illinois, United States, 60432 | |
Pfizer Investigational Site | |
Joliet, Illinois, United States, 60435 | |
United States, Maryland | |
Pfizer Investigational Site | |
Baltimore, Maryland, United States, 21231 | |
United States, North Carolina | |
Pfizer Investigational Site | |
Clinton, North Carolina, United States, 28382 | |
Pfizer Investigational Site | |
Goldsboro, North Carolina, United States, 27534 | |
Pfizer Investigational Site | |
Wilson, North Carolina, United States, 27893 | |
Pfizer Investigational Site | |
Pollocksville, North Carolina, United States, 28573 | |
United States, Tennessee | |
Pfizer Investigational Site | |
Knoxville, Tennessee, United States, 37920 | |
Pfizer Investigational Site | |
Knoxville, Tennessee, United States, 37934 | |
United States, Texas | |
Pfizer Investigational Site | |
Austin, Texas, United States, 78705 | |
Pfizer Investigational Site | |
Austin, Texas, United States, 78745 | |
Pfizer Investigational Site | |
Austin, Texas, United States, 78758 | |
Pfizer Investigational Site | |
San Marcos, Texas, United States, 78666 | |
Pfizer Investigational Site | |
Georgetown, Texas, United States, 78626 | |
Pfizer Investigational Site | |
Austin, Texas, United States, 78759 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer Inc ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A8501003 |
Study First Received: | April 10, 2006 |
Last Updated: | December 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00313768 History of Changes |
Health Authority: | United States: Food and Drug Administration |
advanced carcinoma, non-small cell lung, Phase II, paclitaxel, Taxol, carboplatin, Paraplatin, bevacizumab, Avastin, PF-3512676, immunotherapy,
immunomodulator |
Thoracic Neoplasms Bevacizumab Carboplatin Antimitotic Agents Angiogenesis Inhibitors Carcinoma Respiratory Tract Diseases Lung Neoplasms |
Paclitaxel Lung Diseases Tubulin Modulators Non-small Cell Lung Cancer Antineoplastic Agents, Phytogenic Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |
Thoracic Neoplasms Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Bevacizumab Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents Respiratory Tract Neoplasms Neoplasms by Histologic Type Growth Substances |
Mitosis Modulators Carboplatin Antimitotic Agents Angiogenesis Inhibitors Pharmacologic Actions Carcinoma Neoplasms Paclitaxel Lung Diseases Tubulin Modulators Carcinoma, Non-Small-Cell Lung Antineoplastic Agents, Phytogenic Neoplasms, Glandular and Epithelial |