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This study is to evaluate the safety, tolerability, clinical efficacy and pharmacokinetics of continuous Endostar intravenous infusion combined with pemetrexed and carboplatin in advanced non small cell lung cancer (NSCLC) patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endostar plus pemetrexed/carboplatin | Experimental | 21 days as one cycle, for a total of 4-6 cycles |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carboplatin | Drug | d1, AUC 5, i.v. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Dose Limiting Toxicity | up to 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | up to 6 cycles | |
| Disease Control Rate | up to 6 cycles | |
| Progression-free Survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Li Zhang, MD | Sun Yat-Sen University Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Guangzhou | Guangdong | China |
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| Pemetrexed |
| Drug |
d1, 500 mg/m2, i.v. |
|
| Endostar | Drug | d2-d21, continuous Endostar intravenous infusion, 7.5 mg/m2/d, 15 mg/m2/d or 30 mg/m2/d, etc. |
|
| Centrum | Drug | 1 tablet/day |
|
| up to 2 years |
| Overall Survival | up to 2 years |
| 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 |
|---|---|
| D016190 | Carboplatin |
| D000068437 | Pemetrexed |
| C522911 | endostar protein |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
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