Dasatinib in Combination With Bevacizumab to Treat Advanced Solid Tumors

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT01445509
Phase
PHASE1
Status
Completed

Conditions

  • Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab — DRUG
    Once the MTD of dasatinib with bevacizumab 5 mg/kg IV every two weeks is determined, one final dose level will be accrued with that MTD dose of dasatinib with bevacizumab at 10 mg/kg IV every two weeks in order to determine if we can safely escalate bevacizumab to full dose with dasatinib concurrently.
  • Dasatinib — DRUG
    We will start dasatinib at 50 mg PO QD which is less than half the recommended Phase 2 dose as well as bevacizumab at 5 mg/kg IV every two weeks, which is half the single agent dose. If this is well-tolerated, study drugs will be escalated per schema to maximize the dose of dasatinib when given concurrently.

Study Details

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.

Key Dates

First listed
Oct 3, 2011
Start date
Dec 29, 2008
Status verified
Jan 2026
Primary completion
Dec 18, 2017
Completion
Sep 20, 2018

Study Design

Enrollment
50 participants (actual)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1
    Group 1 will receive dasatinib and bevacizumab together at the start of study in a dose escalation fashion
  • Experimental: Arm 2
    Group 2 will be randomized as to which agent they receive for cycle one. Cycles 2 and beyond are treated using both agents.

Primary Outcome Measure

Determine the toxicity profile of the combination of dasatinib and bevacizumab [ Time Frame: end of treatment ]

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892-

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