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Completed NCT01445509

Dasatinib in Combination With Bevacizumab to Treat Advanced Solid Tumors

Conditions: Solid Tumors

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1
Enrollment: 50
Sponsor: National Cancer Institute (NCI)

Location: National Institutes of Health Clinical Center Bethesda Maryland

Summary

Background: * Bevacizumab inhibits blood vessel growth in cancer cells by blocking a growth factor called VEGF. Dasatinib inhibits the action of proteins called tyrosine kinases, which promote and stimulate blood vessel formation and cancer growth and spread. * Using the two drugs in combination may provide a more effective cancer treatment than either drug used alone. * Both drugs have been approved by the Food and Drug Administration for different cancer types, but their use in combination sis experimental. Objectives: \- To determine the highest doses of the combination of dasatinib and bevacizumab that can be safely given to patients with different cancers and to find out what effects, good and bad, these drugs may have on the patient and the disease. Eligibility: \- Adult patients with an advanced solid tumor cancer that cannot be treated successfully with standard therapies. Design: * Patients in Group 1 receive dasatinib and bevacizumab together throughout the study. The dose is increased in successive groups of three to six patients until the optimum safe dose is determined. Patients take dasatinib by mouth once a day and receive bevacizumab as an infusion through a vein once every 2 weeks in 28-day treatment cycles. * Patients in Group 2 are randomly assigned to receive either dasatinib or bevacizumab for cycle one, and then both drugs for all subsequent cycles. The drug doses are based on the optimum doses found in Group 1 patients. * Patients have a physical examination and blood and urine tests every 2 weeks for cycles 1 and 2, and then every 4 weeks for the duration of treatment. * Patients have CT or MRI scans or another imaging test such as ultrasound every 8 weeks to monitor the cancer s response to treatment. * Tumor biopsies are obtained from patients in Group 2 before treatment, 2 weeks into the first treatment cycle, and 2 weeks into the second cycle. * Dynamic, contrast-enhanced MRI (DCE-MRI) tests are done on patients in Group 2 before treatment, 2 weeks into the first cycle and 4 weeks into the second cycle. This MRI test uses a special non-radioactive dye that shows blood flow in a certain part of the body. * For patients who have been on the study over 2 years, the cycle may be lengthened to 6 or 8 weeks at the discretion of the investigator.

Eligibility Criteria

* INCLUSION CRITERIA: * Patients must have a solid tumor malignancy that is metastatic or unresectable and for which standard curative therapies do not exist or are no longer effective. --Patients must have histological documentation of cancer confirmed in the Laboratory of Pathology/NCI. * Patients must be off prior chemotherapy, radiation therapy, hormonal therapy, or biological therapy for at least 4 weeks. Patients who were receiving mitomycin C, nitrosoureas, bevacizumab or carboplatin must be 6 weeks from the last administration of chemotherapy. Patients with prostate cancer must continue to receive LHRH agonist (unless orchiectomy has been performed). Patients should not be receiving complementary/alternative therapy while on study. Any patient who has undergone therapy with a monoclonal antibody must be at least 4 weeks from the last treatment. * All patients enrolling in group 2 must have at least one lesion deemed safe to biopsy and be willing to undergo the three mandatory biopsies. This determination will be made by a member of the interventional radiology team or surgical associate investigator and an associate investigator. This requirement is not necessary for patients in group 1. * Age \>=18 years. Because no dosing or adverse event data are currently available on the use of dasatinib in combination with bevacizumab in patients \3,000/microl * Hemoglobin \>= 10g/dl * Absolute neutrophil count \>1,200/microl * Platelets \>100,000/microl * total bilirubin \

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT01445509). StuddyBuddy aggregates publicly available trial information.