A Clinical Efficacy Study Of An Oral Tyrosine Kinase Inhibitor Of VEGFR-2 Given In Combination With Chemotherapy
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00074854
First received: December 22, 2003
Last updated: November 8, 2006
Last verified: July 2006
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Purpose
The purpose of this study is to determine whether CP-547,632, an oral VEGFR-2 tyrosine kinase inhibitor when given in combination with chemotherapy (carboplatin and paclitaxel) is effective in the treatment of advanced stage non-small cell lung cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Neoplasms |
Drug: CP-547,632 |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Clinical Efficacy Study Of An Oral Tyrosine Kinase Inhibitor Of VEGFR-2 Given In Combination With Chemotherapy (Paclitaxel And Carboplatin) Vs. Chemotherapy Alone For The Treatment Of Advanced Stage Non-Small Cell Lung Cancer. |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Statistical estimates used on the Stage 1 data indicated low likely-hood of a positive outcome if the study continued to Stage 2. This provided the basis for discontinuation of the trial.
Secondary Outcome Measures:
- Given the outcome of the primary objective, analysis of secondary objectives were not formalized.
| Estimated Enrollment: | 87 |
| Study Start Date: | May 2002 |
| Estimated Study Completion Date: | March 2005 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histologically or cytologically confirmed stage IIIB (inicluding those with pleural effusion), IV or recurrent non-small cell lung cancer (nsclc).
- Bidimensionally measurable disease >2cm x 1 cm by conventional CT Scan or >1 cm x 1cm by spiral CT Scan.
Exclusion Criteria:
- No tumors in close proximity to major veins or arteries.
- No sanguinous pleural effusion due to disease or pericardial effusion suspicious for disease.
- No evidence or history brain metastases.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00074854
Locations
| United States, California | |
| Pfizer Investigational Site | |
| Greenbrae, California, United States, 94904 | |
| Pfizer Investigational Site | |
| San Mateo, California, United States, 94402 | |
| Pfizer Investigational Site | |
| San Pablo, California, United States, 94806 | |
| United States, Florida | |
| Pfizer Investigational Site | |
| Tampa, Florida, United States, 33612-9497 | |
| United States, Louisiana | |
| Pfizer Investigational Site | |
| Covington, Louisiana, United States, 70433 | |
| Pfizer Investigational Site | |
| Metairie, Louisiana, United States, 70002 | |
| Pfizer Investigational Site | |
| Metairie, Louisiana, United States, 70006 | |
| Pfizer Investigational Site | |
| New Orleans, Louisiana, United States, 70115 | |
| United States, Massachusetts | |
| Pfizer Investigational Site | |
| Boston, Massachusetts, United States, 02215 | |
| United States, New York | |
| Pfizer Investigational Site | |
| Stony Brook, New York, United States, 11794 | |
| United States, Pennsylvania | |
| Pfizer Investigational Site | |
| Philadelphia, Pennsylvania, United States, 19111 | |
| United States, Tennessee | |
| Pfizer Investigational Site | |
| Gallatin, Tennessee, United States, 37066 | |
| Pfizer Investigational Site | |
| Hermitage, Tennessee, United States, 37076 | |
| Pfizer Investigational Site | |
| Lebanon, Tennessee, United States, 37087 | |
| Pfizer Investigational Site | |
| Murfreesboro, Tennessee, United States, 37130 | |
| Pfizer Investigational Site | |
| Nashville, Tennessee, United States, 37203 | |
| Pfizer Investigational Site | |
| Nashville, Tennessee, United States, 37205 | |
| Pfizer Investigational Site | |
| Nashville, Tennessee, United States, 37207 | |
| Pfizer Investigational Site | |
| Nashville, Tennessee, United States, 37211 | |
| Pfizer Investigational Site | |
| Smyrna, Tennessee, United States, 37167 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00074854 History of Changes |
| Other Study ID Numbers: | A3521002 |
| Study First Received: | December 22, 2003 |
| Last Updated: | November 8, 2006 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Neoplasms Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms |
Neoplasms by Site Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 21, 2013