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

Clinical trial: S0101 Gemcitabine and Irinotecan in Treating Patients With Metastatic or Recurrent Cancer of the Esophagus

Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
  PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have metastatic or recurrent cancer of the esophagus.

Detailed description: OBJECTIVES:
  -  Determine the 6-month survival rate of patients with metastatic or recurrent carcinoma of the esophagus or gastroesophageal junction treated with gemcitabine and irinotecan.
  -  Determine the qualitative and quantitative toxic effects of this regimen in these patients.
  OUTLINE: Patients receive gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on days 1 and 8. Treatment repeats every 21 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.
  Patients are followed every 3 months for 1 year and then every 6 months for 2 years.
  PROJECTED ACCRUAL: A total of 30-55 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically confirmed metastatic or recurrent carcinoma of the esophagus or gastroesophageal junction
  -  Squamous cell carcinoma OR
  -  Adenocarcinoma
  -  No known brain metastases
  PATIENT CHARACTERISTICS:
  Age:
  -  18 to 100
  Performance status:
  -  Zubrod 0-2
  Life expectancy:
  -  Not specified
  Hematopoietic:
  -  Granulocyte count at least 1,500/mm^3
  -  Platelet count at least 100,000/mm^3
  Hepatic:
  -  Not specified
  Renal:
  -  Creatinine no greater than 1.5 times upper limit of normal
  Cardiovascular:
  -  No uncontrolled hypertension
  -  No unstable angina
  -  No symptomatic congestive heart failure
  -  No myocardial infarction within the past 6 months
  -  No serious uncontrolled cardiac arrhythmia
  Gastrointestinal:
  -  No active inflammatory bowel disease
  -  No significant bowel obstruction
  -  No chronic diarrhea
  Other:
  -  Not pregnant or nursing
  -  Fertile patients must use effective contraception
  -  No active infection requiring systemic therapy
  -  No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  At least 28 days since prior biologic therapy
  -  No prior biologic therapy for metastatic or recurrent disease
  -  No concurrent sargramostim (GM-CSF)
  -  No concurrent immunotherapy for tumor
  Chemotherapy:
  -  At least 28 days since prior chemotherapy
  -  No prior chemotherapy for metastatic or recurrent disease
  -  No prior gemcitabine or irinotecan
  -  Prior adjuvant or neoadjuvant chemotherapy at time of initial diagnosis of localized disease allowed
  -  No other concurrent chemotherapy for tumor
  Endocrine therapy:
  -  See Disease Characteristics
  -  At least 28 days since prior endocrine therapy
  -  No prior endocrine therapy for metastatic or recurrent disease
  -  No concurrent hormonal therapy for tumor
  Radiotherapy:
  -  At least 28 days since prior radiotherapy
  -  No prior radiotherapy for metastatic or recurrent disease
  -  Prior adjuvant or neoadjuvant radiotherapy at time of initial diagnosis of localized disease allowed
  -  No concurrent radiotherapy for tumor
  Surgery:
  -  Prior thoraco-abdominal surgery allowed
  -  At least 3 weeks since prior surgery and recovered
  Other:
  -  No other concurrent anti-cancer therapy for tumor

Relevance to patient case: not relevant