Dasatinib and Lapatinib Ditolsylate in Treating Patients With Advanced Solid Tumors That Cannot Be Removed By Surgery
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.
Unspecified Adult Solid Tumor, Protocol Specific
Drug: lapatinib ditosylate
Other: pharmacological study
Other: laboratory biomarker analysis
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I Trial of the Combination of Dasatinib and Lapatinib|
- Adverse events profile [ Designated as safety issue: Yes ]
- Toxicity profile per NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
- Response profile [ Time Frame: Every 4 weeks ] [ Designated as safety issue: No ]
- Time until any treatment-related toxicity, time until treatment-related grade 3+ toxicity, and time until hematologic nadirs (WBC, ANC, platelets) [ Designated as safety issue: Yes ]
- Time to progression and time to treatment failure [ Designated as safety issue: No ]
- Laboratory correlates [ Designated as safety issue: No ]
|Study Start Date:||August 2008|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
Experimental: Arm I
Patients receive oral dasatinib and lapatinib ditosylate once daily on days 1-28.
Other Names:Drug: lapatinib ditosylate
Other Names:Other: pharmacological study
Correlative study (cohort II only)
Other Name: pharmacological studiesOther: laboratory biomarker analysis
Correlative study (cohort II only)
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00662636
|United States, Arizona|
|Mayo Clinic in Arizona|
|Scottsdale, Arizona, United States, 85259|
|United States, Florida|
|Mayo Clinic in Florida|
|Jacksonville, Florida, United States, 32224-9980|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Charles Erlichman||Mayo Clinic|