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Gemcitabine and cisplatin given together is a standard treatment option for advanced lung cancer patients. The purpose of this study is to assess if the life span is longer in patients taking the investigational drug CP-751,871 in combination with gemcitabine and cisplatin compared to gemcitabine and cisplatin alone. Considering a 10% rate of drop-outs, 1,210 participants will be required in order to have an adequate sample size (1,100 evaluable patients) and power to detect a 30% prolongation of survival on the experimental arm.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CP-751,871 + Gemcitabine + Cisplatin | Experimental | investigational arm |
|
| Gemcitabine + Cisplatin | Active Comparator | standard of care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CP-751,871 | Drug | CP-751,871 20mg/kg every 3 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Dec 2012 |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free survival | Dec 2011 | |
| Objective Response | Dec 2011 | |
| Overall Safety Profile |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| C525021 | figitumumab |
| D002945 | Cisplatin |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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| Cisplatin |
| Drug |
Cisplatin 80 mg/m2 every 3 weeks |
|
| Gemcitabine | Drug | Gemcitabine 1,250 mg/m2 Day1+8 of evey 3 week-cycle |
|
| Cisplatin | Drug | Cisplatin 80 mg/m2 every 3 weeks |
|
| Gemcitabine | Drug | Gemcitabine 1,250 mg/m2 Day1+8 of evey 3 week-cycle |
|
| Dec 2012 |
| Patient Reported Outcome | Dec 2012 |
| Pharmacokinetics | Dec 2012 |
| Anti-drug Antibody | Dec 2012 |
| Biomarker Analysis | Dec 2012 |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006571 |
| Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |