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| ID | Type | Description | Link |
|---|---|---|---|
| 122007-001; | |||
| A07-3423 |
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| Name | Class |
|---|---|
| University of Texas Southwestern Medical Center | OTHER |
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This is a clinical research study to look at the incidence of proteinuria (a condition in which urine contains an abnormal amount of protein) caused by shortened infusions (given into the vein over 10 or 15 minutes) of bevacizumab (a medication prescribed for colon, lung, or breast cancer). There are currently no published studies or clinical data looking at how safe shortened infusions of bevacizumab are in relationship to the side effect of proteinuria. We hypothesis that shortened infusions of bevacizumab will result in an increased risk for proteinuria compared to the standard infusions of this agent.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Shortened infusions of bevacizumab |
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| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the effect of shortened infusions (0.5 mg/kg/min) of bevacizumab on the incidence of proteinuria. | 3-6 months |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the time (number of days) to the incidence of proteinuria with shortened infusions of bevacizumab AND to evaluate the effect of controlled versus uncontrolled hypertension and the incidence of proteinuria. | 3-6 months |
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Inclusion Criteria:
Exclusion Criteria:
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106 patients receiving bevacizumab doses of < 10 mg/kg at a rate of 0.5 mg/kg/min in hematology/oncology outpatient clinic. Most of the patients are likely to have advanced stage colon or rectal cancer.
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| Name | Affiliation | Role |
|---|---|---|
| Sachin Shah, Pharm.D. | Texas Tech University Health Sciences Center School of Pharmacy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA North Texas Health Care System | Dallas | Texas | 75216 | United States | ||
| Parkland Health and Hospital System |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| D012004 | Rectal Neoplasms |
| D011507 | Proteinuria |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| Dallas |
| Texas |
| 75235 |
| United States |
| UT Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |