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The investigators hypothesize that Ca2+/MG2+ infusions will not have a significant effect on oxaliplatin pharmacokinetics.
This is a clinical pharmacology prospective non-randomized trial to determine oxaliplatin pharmacokinetics in the presence and absence of calcium and magnesium supplementation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ca2+/Mg2+ pre & post cycle 1 | Active Comparator | Arm A:Ca2+/Mg2+: Ca++gluconate 1gr & Mg++sulfate 1g given IV pre & post cycle 1 |
|
| Ca2+/Mg2+pre & post cycle 2 | Active Comparator | Arm B:Ca2+/Mg2+: Ca++gluconate 1gr & Mg++sulfate 1g given IV pre & post cycle 2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| (supplement) Calcium and Magnesium | Other | FOLFOX 6: Oxaliplatin (Eloxatin®): 100mg/m2 x 2hrs IV with 250ml of dextrose 5%; leucovorin 200mg/m2 with oxaliplatin; then IV bolus of 5FU 400mg/m2 and 5FU 2400mg/m2 in a 46 hr continuous IV. Each cycle is 14 days, approximately 8-12 cycles planned. XELOX: Oxaliplatin 130mg/m2 x 2hrs IV in 250ml of dextrose 5% on day 1; plus oral capecitabine 1000mg/m2 bid on days 1-15 3 wk cycles. Ca2+/Mg2: Ca++gluconate 1gr & Mg++sulfate 1g given IV pre & post cycle 1 (Arm A) or cycle 2 (Arm B) |
| Measure | Description | Time Frame |
|---|---|---|
| The primary objective of this study is to determine potential pharmacokinetic interactions between oxaliplatin and calcium and magnesium. | Post cycle 2 and 3 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael Sawyer, MD | Contact | 780-432-8248 | Michael.Sawyer@albertahealthservices.ca |
| Name | Affiliation | Role |
|---|---|---|
| Michael Sawyer, MD | Alberta Health services | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cross Cancer Institute | Edmonton | Alberta | T6G 1Z2 | Canada |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D002118 | Calcium |
| D008274 | Magnesium |
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D008673 | Metals, Alkaline Earth |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D008670 | Metals |
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|
|
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D001779 |
| Blood Coagulation Factors |
| D001685 | Biological Factors |
| D019565 | Metals, Light |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |