Phase II Study of Dovitinib and Pilot Study of Fibroblast Growth Factor Receptor Biomarkers in Advanced Non-Small Cell Lung Cancer or Advanced Colorectal Cancer Previously Treated With Anti-Vascular Endothelial Growth Factor Therapy
Inclusion Criteria:
- Histologically confirmed non-small cell lung cancer or colorectal cancer for which no
potentially curative treatment options are available
- Any number of prior treatment regimens are allowed
- Immediate prior treatment regimen must have included an anti-VEGF agent. Acceptable
anti-VEGF therapy includes bevacizumab, sunitinib, or sorafenib. For other anti-VEGF
therapies, contact the principal investigator.
- Last dose administered of bevacizumab must be at least 21-days but not more than
56-days from enrollment.
- Last dose of anti-VEGF tyrosine kinase inhibitor must be at least 7-days but not more
than 56-days from enrollment.
- Willingness to consent to research biopsy
- Measurable disease by RECIST 1.1 criteria
- Available tumor site amenable to core needle biopsy as determined by the treating
investigator. Any questions regarding suitability of site for biopsy will be
adjudicated by the principal investigator.
- Zubrod (ECOG) performance status 0 or 1
- Age ≥ 18 years old
- Patients who give a written informed consent
- Patients must have the following laboratory values:
- Platelets ≥ 100 x 109/L
- Absolute neutrophil count ≥ 1.5 x 109/L Hemoglobin > 9 g/dL
- Serum total bilirubin: ≤ 1.5 x upper limit of normal ULN
- ALT and AST ≤ 3.0 x ULN ( with or without liver metastases)
- Serum creatinine ≤ 1.5 x ULN or serum creatinine >1.5 - 3 x ULN
Exclusion Criteria:
- Patients with known brain metastases
- Patients with another primary malignancy within 3 years prior to starting study drug,
with the exception of adequately treated in-situ carcinoma of the uterine cervix, or
skin cancer
- Patients who have received the last administration of an anticancer therapy including
chemotherapy, immunotherapy, hormonal therapy and monoclonal antibodies that have not
resolved to NCI CTCAE grade 1 or less.
- Patients who have received the last administration of nitrosurea or mitomycin-C ≤ 6
weeks prior to starting study drug, or who have side effects that have not resolved
to NCI CTCAE grade 1 or less.
- Patients who have received targeted therapy ≤ 1 week prior to starting study drug,
or who have not recovered from the side effects of such therapy
- Patients who have had radiotherapy ≤ 4 weeks prior to starting study drug, or ≤ 2
weeks prior to starting study drug in the case of localized radiotherapy or who have
not recovered from radiotherapy toxicities
- Patients who have undergone major surgery, open biopsy or significant traumatic
injury ≤ 4 weeks prior to starting study drug, or patients who have had minor
procedures, percutaneous biopsies or placement of vascular access device ≤ 1 week
prior to starting study drug, or who have not recovered from side effects of such
procedure or injury
- Patients with any of the following concurrent severe and/or uncontrolled medical
conditions which could compromise participation in the study:
- Impaired cardiac function or clinically significant cardiac diseases
- Impairment of gastrointestinal (GI) function or GI disease that may
significantly alter the absorption of dovitinib
- Cirrhosis, chronic active hepatitis or chronic persistent hepatitis
- Known diagnosis of human immunodeficiency virus infection
- Patients who are currently receiving anticoagulation treatment with therapeutic
doses of warfarin
- Other concurrent severe and/or uncontrolled concomitant medical conditions
- Pregnant or breast-feeding women
- Women of child-bearing potential, who are biologically able to conceive, not
employing two forms of highly effective contraception.
- Fertile males not willing to use contraception, as stated above
- Patients unwilling or unable to comply with the protocol