Dasatinib and Lapatinib Ditolsylate in Treating Patients With Advanced Solid Tumors That Cannot Be Removed By Surgery

• Status: Completed
• Trial end date: 2014-12-18
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Collaborator: National Cancer Institute (NCI)
• Treatments: Dasatinib; Lapatinib

Criteria

Inclusion Criteria:

• Histologic proof of cancer that is now unresectable and refractory to or refused all standard treatment for the disease

• Please contact study investigator and/or consult protocol document for specific details on laboratory criteria

• Ability to provide informed consent

• Willingness to return to Mayo Clinic for follow up

• Life expectancy >= 12 weeks

• Negative serum pregnancy test done =< 7 days prior to registration for women of childbearing potential only

• Echocardiogram with ejection fraction > 50%

• ECOG performance status (PS) 0-2

• Able to swallow pills whole (patients with feeding tubes may be eligible if whole pills can be taken and tolerated through the feeding tube)

• Willingness to provide the biologic specimens as required by the protocol for Cohort II, (MTD) patients only

Exclusion Criteria:

• Failure to fully recover from acute, reversible effects of prior chemotherapy regardless of interval since last treatment

• Pregnant women

• Any of the following prior therapies: chemotherapy =< 4 weeks prior to registration; mitomycin C/nitrosoureas =< 6 weeks prior to registration; immunotherapy =< 4 weeks prior to registration; biologic therapy =< 4 weeks prior to registration

• Patients who have been treated with Avastin, Herceptin, or Erbitux are eligible if last treatment is >= 4 weeks; molecularly targeted agents (erlotinib, sunitinib, sorafenib, gefitinib, imatinib) =< 4 weeks prior to registration; radiation therapy =< 4 weeks prior to registration; radiation to > 25% of bone marrow

• CNS metastases that are not stable for at least 4 weeks prior to registration based on imaging, clinical assessment, and use of steroids

• Men or women of childbearing potential who are unwilling to employ adequate contraception throughout the study and until 4 weeks following study

• Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational (utilized for a non-FDA-approved indication and in the context of a research investigation)

• Current therapy with a CYP3A4 inhibitor or inducer

• Known standard therapy for the patient's disease that is not refractory to treatment that is potentially curative or definitely capable of extending life expectancy

• Uncontrolled pleural or pericardial effusion of any grade

• Uncontrolled angina, congestive heart failure or MI within 6 months prior to registration

• Diagnosed congenital long QT syndrome

• Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes)

• Prolonged QTc interval on pre-entry electrocardiogram (> 450 msec)

• Subjects with potassium or magnesium that are not within normal limits and cannot be corrected prior to registration

• New York Heart Association classification III or IV

• Diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies)

• Ongoing or recent (=< 3 months prior to registration) significant gastrointestinal bleeding

• Prophylactic use of colony-stimulating factors during the study is not allowed

• Diagnosed congenital bleeding disorders (e.g., von Willebrand's disease)

• G.I conditions that may interfere with drug absorption such as Ulcerative Colitis, Crohn's Disease, and Short Bowel Syndrome

• Active hepatic or biliary disease (with the exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator's assessment)

• Nursing women

• Uncontrolled infection

• Seizure disorder