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Closed by IRB on 3/28/22
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This study will combine cabozantinib with pemetrexed to treat patients with non-small cell lung cancer, urothelial cancer and advanced malignant mesothelioma. This study will test the safety of both drugs used together and see what effect (good or bad) it has no participants and their cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cabozantinib + Pemetrexed | Experimental | Pemetrexed 500mg/m2 IV day 1 of each 21 day cycle + Cabozantinib 20-60mg by mouth once a day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cabozantinib | Drug | start at 20mg then increase by 20mg every cycle or until there's a dose-limiting toxicity. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assess the maximum tolerated dose (MTD) of cabozantinib in combination with pemetrexed | Dose-limiting toxicity of grade 3 or higher using CTCAE 5 | 4 weeks or 28 days assessment. |
| Measure | Description | Time Frame |
|---|---|---|
| Assess objective response rate (RR) | RR measured by Tumor response evaluation with RECIST | To be measured through study completion; an average of 1 year. |
| Progression-free survival (PFS) | PFS measured from the time of study treatment to the date of progression. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nagla A Karim, MD, PhD | Augusta University Georgia Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Augusta University Georgia Cancer Center | Augusta | Georgia | 30912 | United States |
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| Pemetrexed | Drug | Start with 400mg/m2, then increase and maintain 500mg/m2 unless dose-limiting toxicity. |
|
| To be measured through study completion; an average of 1 year. |
| Overall survival (OS). | Measured from the time of start of treatment to time of death or time of last assessment. | OS measured through study completion, and an average of 1 year |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D002295 | Carcinoma, Transitional Cell |
| D000086002 | Mesothelioma, Malignant |
| 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 |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D008654 | Mesothelioma |
| D000236 | Adenoma |
| D018301 | Neoplasms, Mesothelial |
| D010997 | Pleural Neoplasms |
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| ID | Term |
|---|---|
| C558660 | cabozantinib |
| D000068437 | Pemetrexed |
| ID | Term |
|---|---|
| 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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