Dasatinib and Erlotinib in Non-Small Cell Lung Cancer (NSCLC)

Inclusion Criteria

• Advanced malignancy that is appropriate for systemic therapy without curative intent.
• Patients must provide verbal and written informed consent indicating they are aware of the investigational nature of the study. Parental consent and patient assent is required for those aged 16-17.
• Patients must be at least 16 years of age.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
• Adequate hematologic, hepatic, and renal function as follows: creatinine /= 1500/mm^3; platelets >/= 75,000 mm^3; hemoglobin >/= 10 g/dL.
• Serum potassium, magnesium, and phosphate within the institutional limits of normal. Patients with low potassium, phosphate, or magnesium levels may be repleted to allow for protocol entry.
• Serum calcium >/= the institutional limits of normal. Patients with low calcium levels may be repleted to allow for protocol entry.
• Ability to take oral medication (dasatinib and erlotinib must be swallowed whole)
• Patients-both males & females-w/reproductive potential must agree to use an adequate method of contraception to include hormonal contraceptives (birth control pills, injections, implants), intrauterine device (IUD), barrier contraceptive with spermicide, and/or abstinence throughout the study & for at least 4 wks after the study drugs are stopped. Females w/ reproductive or childbearing potential include any female who has experienced menarche & who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal
• -Continued from Inclusion #9 - [defined as amenorrhea >/=12 consecutive mths;or women on hormone replacement therapy (HRT) w/ documented serum follicle stimulating hormone (FSH) level > 35 milli-International unit (mIU)/mL]. Prior to study enrollment, women of childbearing potential must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy.
• Women of childbearing potential must provide a negative pregnancy test (serum or urine) within 72 hours prior to the start of study drug administration.
• Asymptomatic brain metastases with prior cranial irradiation or resection are acceptable if there is no bleeding, no midline shift, and no need for steroids or anti-convulsants. Asymptomatic brain metastasis without prior treatment are acceptable if the largest lesion is less than 7 mm in diameter, there is no bleeding, midline shift, nor need for steroids or anti-convulsants.
• Patient agrees to discontinue St. Johns Wort at least 5 days before starting dasatinib or erlotinib.
• Patient agrees that IV bisphosphonates will be withheld for the first 8 weeks of dasatinib therapy due to risk of hypocalcemia.
• The patient's O^2 saturation must be >92% on room air.
• (Phase II only) - Patient has never received prior therapy with dasatinib, or erlotinib, or another epidermal growth factor receptor (EGFR) or Src family kinase (SFK) inhibitor.
• (Phase I only) - Histological or unequivocal cytological proof of solid tumor malignancy.
• (Phase I only) - At least one prior systemic chemotherapy or biological therapy for recurrent or metastatic solid tumor (i.e., this protocol therapy must be administered as second line or greater), ), except if there is no standard or experimental systemic therapy available. If no effective systemic agent is available for first line therapy, then patients may be enrolled on the phase I as first line therapy.
• (Phase I only) - Prior radiotherapy is permitted (see exclusion criterion 4 for details on unallowable radiotherapy).
• (Phase II only) - Histological or unequivocal cytological proof of NSCLC.
• (Phase II only) - NSCLC that is appropriate for systemic therapy without curative intent: Stage IV, Stage IIIB with pleural effusion, or incurable recurrent disease after surgery or radiotherapy.
• (Phase II only) - Zero to one line of prior systemic