Chemotherapy & Erlotinib in Treating Patients w/ Esophageal or Gastroesophageal Cancer That Cannot Be Removed by Surgery

Trial 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

• Histologically confirmed esophageal carcinoma (squamous or adenocarcinoma).
• Surgically unresectable disease and/or metastatic disease. Endoscopic accessibility
  of primary tumor preferred but not a prerequisite.
• No prior chemotherapy therapy except for neoadjuvant treatment (radiation and/or
  chemotherapy). Prior treatment with EGFR-inhibiting agents NOT allowed.
• Life expectancy >12 weeks.
• Ability to take and retain oral medications, or have an appropriate percutaneous
  feeding tube in place.
• ECOG performance status of 0, 1, or 2 (Karnofsky Performance Status [KPS] ≥50%).
• Measurable disease by RECIST criteria and computerized tomographic scan performed
  within 28 days prior to registration.
• Organ system function assessed within 7 days prior to registration and within the
  following parameters:
• Absolute neutrophil count ≥ 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;
• AST (SGOT) or ALT (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.
• Aged 18 years or older
• 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 greater than or equal to 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.

• Presence of a Kras mutation.
• Lack of expression of EGFR.
• 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.
• Concomitant use of 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.

Detailed Description

Final eligibility is determined by the health professionals conducting the trial and the protocol approved by the Committee on Human Resources (CHR) at the University of California, San Francisco (UCSF). The Patient Consent Form for this trial is available upon request. For more information about this trial, please see the full posting at ClinicalTrials.gov.

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