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This study will determine the maximum-tolerated dose (MTD) for oral bosutinib when used in combination with pemetrexed. The MTD is the highest dose of bosutinib with pemetrexed that can be given without causing severe side effects. This study will also test the safety of this combination and see what effects (good or bad) it has on participants and their cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bosutinib and Pemetrexed | Experimental | Bosutinib and pemetrexed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bosutinib | Drug | 100mg daily for 4 cycles (21 days per cycle) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Dose-limiting toxicity of the combination of bosutinib and pemetrexed | CTCAE Grade 3 or 4 non-hematologic toxicities other than alopecia, nausea and vomiting. | 21 days |
| Maximum tolerated dose of the combination of bosutinib and pemetrexed | completion of dose escalation |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events of the combination of bosutinib and pemetrexed | 16 weeks | |
| Anti-tumor response rate | 6 and 12 weeks | |
| Progression-free survival |
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Inclusion Criteria:
Exclusion Criteria:
- Untreated or symptomatic brain metastases.
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| Name | Affiliation | Role |
|---|---|---|
| Nagla Karim, MD | 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 |
500 mg/m2 every 21 days for 4 cycles |
|
| 6 and 12 weeks |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008654 | Mesothelioma |
| D001749 | Urinary Bladder Neoplasms |
| D010051 | Ovarian Neoplasms |
| D013945 | Thymoma |
| D013953 | Thymus Neoplasms |
| D002583 | Uterine Cervical Neoplasms |
| 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 |
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D018301 | Neoplasms, Mesothelial |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D005833 | Genital Neoplasms, Female |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D018193 | Neoplasms, Complex and Mixed |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D014594 | Uterine Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
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| ID | Term |
|---|---|
| C471992 | bosutinib |
| 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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