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See Termination Reason in Detailed Description.
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| B | Active Comparator | Standard of care chemotherapy |
|
| A | Experimental | Standard of care chemotherapy plus experimental intervention (PF-3512676) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| paclitaxel + carboplatin + bevacizumab | Drug | paclitaxel 200 mg/m2 intravenously Day 1 of each 21 day cycle x 6 cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | 110 Events |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Tumor Progression | End of treatment | |
| Overall Objective Response Rate | Time of progressive disease | |
| Duration of Response |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Bessemer | Alabama | 35022 | United States | ||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| carboplatin + paclitaxel + bevacizumab + PF-3512676 | Drug | carboplatin AUC 6 intravenously on Day 1 of each 21 day cycle x 6 cycles |
|
|
| Time of progression |
| Overall Survival | Time of death |
| Overall safety profile | 28 days post treatment |
| Birmingham |
| Alabama |
| 32511 |
| United States |
| Pfizer Investigational Site | Birmingham | Alabama | 35205 | United States |
| Pfizer Investigational Site | Birmingham | Alabama | 35209 | United States |
| Pfizer Investigational Site | Birmingham | Alabama | 35213 | United States |
| Pfizer Investigational Site | Birmingham | Alabama | 35235 | United States |
| Pfizer Investigational Site | Mobile | Alabama | 36607 | United States |
| Pfizer Investigational Site | Fountain Valley | California | 92708 | United States |
| Pfizer Investigational Site | Los Angeles | California | 90033 | United States |
| Pfizer Investigational Site | Cocoa Beach | Florida | 32931 | United States |
| Pfizer Investigational Site | Merritt Island | Florida | 32952 | United States |
| Pfizer Investigational Site | Rockledge | Florida | 32955 | United States |
| Pfizer Investigational Site | Titusville | Florida | 32796 | United States |
| Pfizer Investigational Site | Valdosta | Georgia | 31602 | United States |
| Pfizer Investigational Site | Joliet | Illinois | 60432 | United States |
| Pfizer Investigational Site | Joliet | Illinois | 60435 | United States |
| Pfizer Investigational Site | Baltimore | Maryland | 21231 | United States |
| Pfizer Investigational Site | Clinton | North Carolina | 28382 | United States |
| Pfizer Investigational Site | Goldsboro | North Carolina | 27534 | United States |
| Pfizer Investigational Site | Pollocksville | North Carolina | 28573 | United States |
| Pfizer Investigational Site | Wilson | North Carolina | 27893 | United States |
| Pfizer Investigational Site | Knoxville | Tennessee | 37920 | United States |
| Pfizer Investigational Site | Knoxville | Tennessee | 37934 | United States |
| Pfizer Investigational Site | Austin | Texas | 78705 | United States |
| Pfizer Investigational Site | Austin | Texas | 78745 | United States |
| Pfizer Investigational Site | Austin | Texas | 78758 | United States |
| Pfizer Investigational Site | Austin | Texas | 78759 | United States |
| Pfizer Investigational Site | Georgetown | Texas | 78626 | United States |
| Pfizer Investigational Site | San Marcos | Texas | 78666 | United States |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D016190 | Carboplatin |
| D000068258 | Bevacizumab |
| C483020 | ProMune |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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