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

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.

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