s0101 gemcitabine and irinotecan in treating patients with metastatic or recurrent cancer of the esophagus

Conditions: Esophageal Cancer; Gastric Cancer

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.

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

Keywords: stage iv gastric cancer recurrent gastric cancer stage iv esophageal cancer recurrent esophageal cancer adenocarcinoma of the stomach squamous cell carcinoma of the esophagus adenocarcinoma of the esophagus