Bladder Cancer, Carcinoma, Non-Small-Cell Lung, Mesothelioma, Ovarian Cancer, Peritoneal Cancer, Thymoma, Thymus Cancer, Uterine Cervical Cancer
Conditions
Brief summary
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.
Interventions
DRUGBosutinib
100mg daily for 4 cycles (21 days per cycle)
DRUGPemetrexed
500 mg/m2 every 21 days for 4 cycles
Sponsors
Nagla Abdel Karim
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Pathologically or cytologically proven advanced, metastatic non-squamous non-small cell lung cancer, pleural malignant mesothelioma, bladder or urethral cancer, ovarian cancer, primary peritoneal cancer, thymoma and thymic cancer and uterine cervical cancer. * Measurable disease * Life expectancy of greater than 3 months. * Ability to take folic acid, vitamin B12, and dexamethasone according to protocol.
Exclusion criteria
\- Untreated or symptomatic brain metastases.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose-limiting toxicity of the combination of bosutinib and pemetrexed | 21 days | CTCAE Grade 3 or 4 non-hematologic toxicities other than alopecia, nausea and vomiting. |
| Maximum tolerated dose of the combination of bosutinib and pemetrexed | completion of dose escalation | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events of the combination of bosutinib and pemetrexed | 16 weeks |
| Anti-tumor response rate | 6 and 12 weeks |
| Progression-free survival | 6 and 12 weeks |
Countries
United States
Outcome results
None listed