RATIONALE: Dasatinib and lapatinib ditoslylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase I trial is studying the side effects and best dose of dasatinib and lapatinib ditoslylate when given together in treating patients with advanced solid tumors that cannot be removed by surgery.
PRIMARY OBJECTIVES: I. To determine the maximally tolerated dose of dasatinib combined with lapatinib. II. To describe the toxicities associated with this treatment combination. III. To assess the pharmacokinetic interaction of lapatinib and dasatinib. IV. To assess the effect of the lapatinib and dasatinib combination on circulating tumor cells and on osteoclast precursor activation. V. To study the association of clinical (toxicity and/or tumor response or activity) with the pharmacokinetic parameters, and/or biologic (pharmacodynamic) results. VI. To describe the responses of this treatment combination. OUTLINE: This is a multicenter, phase I, dose-escalation study. COHORT I: Patients receive oral dasatinib and oral lapatinib ditosylate once daily on days 1-28. COHORT II: Patients receive oral dasatinib once daily on days 1 and 9-28 and oral lapatinib ditosylate once daily on days 2-28 of course 1. In all subsequent courses patients receive oral dasatinib and oral lapatinib ditosylate once daily on days 1-28. In both cohorts courses repeat every 28 days, in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed for 3 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
27
Mayo Clinic in Arizona
Scottsdale, Arizona, United States
Mayo Clinic in Florida
Jacksonville, Florida, United States
Mayo Clinic
Rochester, Minnesota, United States
Adverse events profile
Toxicity profile per NCI CTCAE v3.0
Response profile
Time frame: Every 4 weeks
Time until any treatment-related toxicity, time until treatment-related grade 3+ toxicity, and time until hematologic nadirs (WBC, ANC, platelets)
Time to progression and time to treatment failure
Laboratory correlates
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Correlative study (cohort II only)