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| ID | Type | Description | Link |
|---|---|---|---|
| H3E-IT-S043 |
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Open label single arm phase II study of Pemetrexed plus Oxaliplatin in patients with advanced gastric carcinoma not previously treated with palliative chemotherapy. 43 Patients will be enrolled in this local trial. The primary objective of this study is to determine the response rate of the treatment.Schedule for this study is as follows: 6 cycles/21 days of Pemetrexed 500 mg/m2 followed by Oxaliplatin 120 mg/m2. This study will also include pharmacogenomic and pharmacogenetic investigations in order to assess determinants of efficacy and toxicity of the treatment with Pemetrexed and Oxaliplatin in the study population.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pemetrexed | Drug | |||
| oxaliplatin | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| The primary objective of this study is to determine the response rate of Pemetrexed plus oxaliplatin as first-line therapy in patients with advanced gastric carcinoma. |
| Measure | Description | Time Frame |
|---|---|---|
| The secondary objectives of this study are to evaluate: | ||
| The following time to event efficacy measures:Duration of overall response for responding patients-Time to documented progressive disease-Time to treatment failure-Overall survival-The quantitative and qualitative toxicity of pemetrexed plus oxaliplatin. |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Monday-Friday 9 am-5 pm Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-371-615-4559) Mon - Fri from 9 AM - 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Ancona | Italy |
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| ID | Term |
|---|---|
| D000068437 | Pemetrexed |
| D000077150 | Oxaliplatin |
| ID | Term |
|---|---|
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 |
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| Determinants of efficacy and toxicity of the treatment with pemetrexed and oxaliplatin in the patient population by means of pharmacogenomic and pharmacogenetics investigations: Quantitative analysis of TS, DHFR, GARFT, RFC, MRP5, DPD, TP, FPGS and ERCC1 |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-371-615-4559) Mon - Fri from 9 AM - 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Bari | Italy |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-371-615-4559) Mon - Fri from 9 AM - 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Bergamo | Italy |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-371-615-4559) Mon - Fri from 9 AM - 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Brescia | Italy |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-371-615-4559) Mon - Fri from 9 AM - 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Florence | Italy |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-371-615-4559) Mon - Fri from 9 AM - 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Gorgonzola | Italy |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-371-615-4559) Mon - Fri from 9 AM - 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Mantua | Italy |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-371-615-4559) Mon - Fri from 9 AM - 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Milan | Italy |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-371-615-4559) Mon - Fri from 9 AM - 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Padova | Italy |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-371-615-4559) Mon - Fri from 9 AM - 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Parma | Italy |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-371-615-4559) Mon - Fri from 9 AM - 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Roma | Italy |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-371-615-4559) Mon - Fri from 9 AM - 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Varese | Italy |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-371-615-4559) Mon - Fri from 9 AM - 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Verona | Italy |
| 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 |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |