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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Gemcitabine Plus Irinotecan in Patients With Esophageal Cancer, Phase II

Conditions
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Esophageal Cancer, Gastric Cancer

Intervention / Treatment
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* Drug: gemcitabine hydrochloride
* Drug: irinotecan hydrochloride


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gemcitabine + Irinotecan<br>Gemcitabine 1000mg/m2 IV over 30 min on Days 1,8 q21days; Irinotecan 100mg/m2 IV over 90 min on Days 1,8 q21days | Drug: gemcitabine hydrochloride<br>* 1,000mg/m2, IV over 30 min, days 1 & 8, q 21 days<br>* Other names: Gemzar (NSC-613327);Drug: irinotecan hydrochloride<br>* 100 mg/m2, IV over 90 min, days 1 & 8, q 21days<br>* Other names: CPT-11 (NSC-616348);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6-month survival rate | To assess the six-month survival rate in patients with esophageal cancer treated with a gemcitabine-irinotecan combination chemotherapy regimen. | 6 months after registration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicities | To assess the qualitative and quantitative toxicities associated with this regimen in a Phase II study. | Week 1 and Week 2 of each cycle | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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