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

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.

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 Criteria:
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