Clinical trial NCT00524121 (phase 2, status: completed)
Conditions: esophageal cancer
ICD codes: K22.2, K22.81, Q39.4, P78.83, I85.00, I85.01, I85.10
Drugs: erlotinib hydrochloride
SMILES: COCCOC1=CC2=C(C=C1OCCOC)C(NC1=CC(=CC=C1)C#C)=NC=N2
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Biopsy-proven primary squamous cell carcinoma or adenocarcinoma of the esophagus or
             gastroesophageal (GE) junction

               -  GE junction tumors with 50% or more tumor located in the esophagus determined by
                  radiologic or endoscopic evaluation

               -  Stage I-IVA disease determined by CT scan or MRI of the chest and abdomen

                    -  Stage IVB disease allowed if metastases to distant regional lymph nodes
                       (celiac or cervical) only and no other sites

          -  Not a surgical candidate and ineligible for chemotherapy due to any of the following:

               -  Neuropathy

               -  Cardiac disease

               -  Performance status 2

               -  General overall condition felt by the investigator to be a contraindication to
                  platinum-based therapy

          -  Bronchoscopy with biopsy and cytology required if primary esophageal cancer is < 26 cm
             from incisors

          -  No evidence of clinically active interstitial lung disease (patients who are
             asymptomatic with chronic, stable, radiographic lung changes allowed)

        PATIENT CHARACTERISTICS:

          -  ECOG performance status 0-2

          -  Life expectancy > 4 months

          -  WBC ≥ 3,000/mm³

          -  ANC ≥ 1,500/mm³

          -  Platelet count > 100,000/mm³

          -  Bilirubin ≤ 1.3 mg/dL

          -  ALT and AST ≤ 2.5 times upper limit of normal (ULN)

          -  Alkaline phosphatase ≤ 2.5 times ULN

          -  No prior malignancies except basal cell or squamous cell skin cancer, in situ cervical
             cancer, or superficial transitional cell bladder cancer, unless diagnosed and/or
             treated > 2 years prior to current study and are without evidence of recurrence

          -  No history of allergy to erlotinib or any of its excipients

          -  No serious, uncontrolled, concurrent infection

          -  No clinically serious, uncontrolled medical conditions that the investigator feels
             might compromise study participation

          -  No lack of physical integrity of the upper gastrointestinal tract or malabsorption
             syndrome

          -  No unwillingness to participate or inability to comply with the protocol for the
             duration of the study

        PRIOR CONCURRENT THERAPY:

          -  No prior chemotherapy or radiotherapy for this tumor

          -  No prior resection or attempted resection of esophageal cancer

          -  No prior anti-epidermal growth factor receptor therapy (unless given in an adjuvant
             setting and completed at least 12 months earlier)

          -  No participation in any investigational drug study within the past 4 weeks

          -  No HIV-positive patients receiving antiretroviral therapy

          -  No concurrent CYP3A4/5 inducers or inhibitors