Esophageal Cancer, Gastric Cancer
Conditions
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
Brief 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.
Interventions
1,000mg/m2, IV over 30 min, days 1 & 8, q 21 days
100 mg/m2, IV over 90 min, days 1 & 8, q 21days
Sponsors
Study design
Eligibility
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 6-month survival rate | 6 months after registration | To assess the six-month survival rate in patients with esophageal cancer treated with a gemcitabine-irinotecan combination chemotherapy regimen. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Toxicities | Week 1 and Week 2 of each cycle | To assess the qualitative and quantitative toxicities associated with this regimen in a Phase II study. |
Countries
United States