Chemotherapy & Erlotinib in Treating Patients w/ Esophageal or Gastroesophageal Cancer That Cannot Be Removed by Surgery
Condition: Esophageal Cancer
MeSH terms: Esophageal Neoplasms
Intervention: Erlotinib; 5-fluorouracil; Leucovorin; Oxaliplatin
Intervention description: Tarceva single agent therapy: 150 mg/day PO; 5-FU bolus: 400 mg/m2 IV once every 2 weeks for 16 weeks 5-FU infusion: 2400 mg/m2 IV over 46-48 hours, once every 2 weeks for 16 weeks; 400 mg/m2 IV once every 2 weeks for 16 weeks; 85 mg/m2 IV once every 2 weeks for 16 weeks
Intervention MeSH terms: Leucovorin; Fluorouracil; Oxaliplatin; Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: metastatic esophageal cancer; erlotinib; folfox; advanced esophageal cancer; unresectable esophageal cancer

Summary:

      The purpose of this study is to test the safety and effectiveness of erlotinib and FOLFOX in
      patients with esophageal or gastro-esophageal cancer that cannot be removed by surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed esophageal carcinoma (squamous or adenocarcinoma)

          -  Surgically unresectable disease and/or metastatic disease; endoscopic accessibility of
             the primary tumor is preferred but not a prerequisite

          -  No prior chemotherapy therapy except for neoadjuvant treatment (radiation and/or
             chemotherapy); prior treatment with EGFR-inhibiting agents is not allowed

          -  Life expectancy > 12 weeks

          -  Patients must have the ability to take and retain oral medications or have an
             appropriate percutaneous feeding tube in place

          -  Patients must have Eastern Cooperative Oncology Group (ECOG) performance status of 0,
             1, or 2 (Karnofsky Performance Status (KPS) >= 50%)

          -  Patients must have measurable disease by Response Evaluation Criteria in Solid Tumors
             (RECIST) criteria and radiographic imaging performed within 28 days prior to
             registration

          -  Absolute neutrophil count (ANC) >= 1500/mL

          -  Platelet count >= 100,000/mL

          -  Hemoglobin level >= 10.0 gm/dL

          -  Serum creatinine =< 1.5 x IULN (institutional upper limits of normal); OR measured
             creatinine clearance >= 60 mL/min

          -  Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase (SGOT)) or
             alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase (SGPT)) =< 2.5 x
             IULN (unless the liver is involved by tumor, in which case it must be =< 5.0 x IULN)

          -  Total bilirubin =< 1.5 x IULN

          -  Provision of written informed consent

          -  Women of childbearing potential (WOCBP) must be willing to practice acceptable methods
             of birth control to prevent pregnancy; WOCBP are any females who have experienced
             menarche and who have not undergone surgical sterilization (hysterectomy, bilateral
             tubal ligation, or bilateral oophorectomy), who are not postmenopausal (defined as
             amenorrhea >= 12 consecutive months), or are on hormone replacement therapy;
             acceptable methods of birth control include oral or hormonal contraceptives and
             barrier methods (e.g., condom, diaphragm) used in combination with other methods
             (e.g., spermicide)

          -  Male patients who are capable of fathering a child must avoid doing so while
             participating in this study through the use of acceptable methods of birth control;
             this is a precautionary measure because this study involves chemotherapy agents

        Exclusion Criteria:

          -  Presence of a Kras mutation

          -  Lack of expression of EGFR (tumors that do not have detectable EGFR staining in at
             least 10% of tumor cells will not be considered EGFR-positive)

          -  Prior treatment with EGFR-inhibiting agents, chemotherapy, or radiotherapy for
             esophagogastric carcinomas (other than neoadjuvant treatment as noted in inclusion
             criteria)

          -  Patients must not be receiving any other investigational agents; use of erythropoietin
             is allowable; secondary prophylaxis with granulocyte colony stimulating factor (G-CSF)
             (Filgrastim) is allowable

          -  The patient concomitantly uses phenytoin, carbamazepine, barbiturates, rifampicin,
             phenobarbital, or St. John's wort

          -  Uncontrolled brain metastases

          -  Patients must not have uncontrolled intercurrent illness at the time of registration
             including, but not limited to, ongoing or active infection, symptomatic congestive
             heart failure, unstable angina, pectoris, cardiac arrhythmia, or psychiatric
             illness/social situations that would limit compliance with study requirements

          -  Patients must not have current New York Heart Association Class III or IV heart
             disease

          -  Known human immunodeficiency virus (HIV) infection

          -  Pregnant or breast-feeding women

          -  Patients who have had prior malignancies, except non-melanoma skin cancer (basal or
             squamous cell carcinoma) are not eligible for this study; unless greater than 5 years
             has passed since the event

          -  Known severe hypersensitivity to Tarceva

          -  Treatment with a non-approved or investigational drug within 30 days before day 1 of
             trial treatment

          -  Incomplete healing from previous oncologic or other major surgery

          -  Serum creatinine level greater than Common Toxicity Criteria (CTC) grade 2