Patient case: 67-year-old male with esophageal cancer; genetic feature: EGFR

Clinical trial: Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Esophageal Cancer

Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells.
  PURPOSE: Phase I trial to study the effectiveness of chemotherapy plus radiation therapy in treating patients who have advanced cancer of the esophagus.

Detailed description: OBJECTIVES:
  -  Determine the dose limiting toxicity of irinotecan when given weekly with cisplatin and concurrent external beam multifield radiotherapy in patients with locally advanced carcinoma of the esophagus or gastroesophageal junction.
  -  Determine the maximum tolerated dose and the recommended phase II dose of irinotecan in this regimen in this patient population.
  -  Evaluate the complete response rate in these patients to one course of induction chemotherapy followed by concurrent chemotherapy and radiotherapy.
  OUTLINE: This is a dose escalation study of irinotecan.
  Patients receive induction chemotherapy with cisplatin IV over 30 minutes followed by irinotecan IV over 30 minutes on days 1, 8, 15, and 22. Following 2 weeks of rest, patients begin chemoradiation. Patients receive cisplatin and irinotecan as above on days 1, 8, 22, and 29 and radiotherapy once daily 5 days a week for 5-6 weeks.
  Cohorts of 3-6 patients receive escalating doses of irinotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities.
  Patients are followed every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.
  PROJECTED ACCRUAL: A total of 3-24 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically confirmed squamous cell carcinoma or adenocarcinoma of the esophagus or gastroesophageal junction
  -  T1, N1, M0 or T2-4, Nx, M0
  -  No supraclavicular or celiac lymph nodes
  -  Previously untreated, newly diagnosed tumors OR
  -  Prior resection without adjuvant therapy with local regional failure
  -  Positive microscopic margin on resection of all gross disease allowed provided no metastatic disease
  -  No positive malignant cytology of the pleura, pericardium, or peritoneum
  -  No biopsy proven tumor invasion of the tracheobronchial tree or tracheoesophageal fistula
  PATIENT CHARACTERISTICS:
  Age:
  -  18 and over
  Performance status:
  -  Karnofsky 70-100% OR
  -  ECOG 0-2
  Life expectancy:
  -  Not specified
  Hematopoietic:
  -  Absolute neutrophil count greater than 1,500/mm^3
  -  Platelet count at least 100,000/mm^3
  -  Hemoglobin at least 9.0 g/dL
  Hepatic:
  -  Bilirubin no greater than 1.5 mg/dL
  -  No known Gilbert's disease
  Renal:
  -  Creatinine no greater than 1.5 mg/dL
  -  No hypercalcemia
  Cardiovascular:
  -  No New York Heart Association class III or IV heart disease
  -  No myocardial infarction within the past 6 months
  -  No uncontrolled hypertension
  Other:
  -  Not pregnant or nursing
  -  Negative pregnancy test
  -  Fertile patients must use effective contraception
  -  No other severe concurrent conditions (e.g., severe uncontrolled diabetes, uncontrolled infections, or cerebral vascular disease)
  -  No other malignancy within the past 5 years except basal cell carcinoma of the skin or carcinoma in situ of the cervix
  -  No history of seizure disorder currently receiving phenytoin, phenobarbital, or other antiepileptic medication
  -  No other concurrent medical or psychiatric condition or disease that would preclude study entry
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  Not specified
  Chemotherapy:
  -  No prior chemotherapy for esophageal cancer including adjuvant chemotherapy
  Endocrine therapy:
  -  Not specified
  Radiotherapy:
  -  No prior radiotherapy for esophageal cancer including adjuvant radiotherapy
  -  No prior mantle, chest, pelvic, or hemibody radiotherapy
  Surgery:
  -  See Disease Characteristics
  Other:
  -  No concurrent prochlorperazine on day of irinotecan administration

Relevance to patient case: not relevant