Oxaliplatin and Capecitabine in Treating Patients With Advanced Esophageal Cancer or Stomach Cancer

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 combining oxaliplatin with capecitabine in treating patients who have advanced esophageal cancer or stomach cancer.

Detailed Description
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OBJECTIVES: Primary Determine the objective tumor response rate of patients with advanced adenocarcinoma of the esophagus, gastroesophageal junction, or gastric cardia treated with oxaliplatin and capecitabine. Secondary Determine the time to progression and overall survival of patients treated with this regimen. Determine the toxic effects of this regimen in these patients. Assess the quality of life of patients treated with this regimen. OUTLINE: Patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-14. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients with complete response (CR) receive 2 additional courses after CR. Quality of life is assessed at baseline and then every 3 weeks (prior to each course of chemotherapy). Patients are followed every 3 months for 1 year and then every 6 months for 2 years.

Official Title
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A Phase II Study of Oxaliplatin and Capecitabine in Patients With Measurable Metastatic Adenocarcinoma of the Esophagus, Gastroesophageal Junction, and Gastric Cardia

Conditions
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Esophageal Cancer, Gastric Cancer

Intervention / Treatment
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* Drug: capecitabine
* Drug: oxaliplatin


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically or cytologically confirmed adenocarcinoma of the esophagus, gastroesophageal junction, or gastric cardia for which no potentially curative or significant palliative therapy exists Unresectable disease Gastric cardia is defined as no more than 5 cm from the gastroesophageal junction into the stomach Measurable disease No known CNS metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin no greater than upper limit of normal (ULN) AST no greater than 3 times ULN Alkaline phosphatase no greater than 2 times ULN Renal: Creatinine no greater than 1.5 times ULN Creatinine clearance at least 60 mL/min Cardiovascular: No New York Heart Association class III or IV heart disease Other: Able to swallow capecitabine No unresolved gastrointestinal bleeding No uncontrolled infection No chronic debilitating disease No peripheral neuropathy grade 2 or greater No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or adequately treated noninvasive carcinoma Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunotherapy or biological therapy for recurrent or metastatic disease No concurrent biologic agents Chemotherapy: No prior chemotherapy for recurrent or metastatic disease Prior adjuvant or neoadjuvant chemotherapy (including combination chemotherapy and radiotherapy) allowed No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: See Chemotherapy No prior radiotherapy for recurrent or metastatic disease No prior radiotherapy to more than 25% of the bone marrow Prior adjuvant or neoadjuvant radiotherapy allowed More than 4 weeks since prior radiotherapy No concurrent radiotherapy Surgery: More than 4 weeks since prior abdominal exploration with surgical resection More than 3 weeks since prior abdominal exploration without surgical resection Other: No concurrent oral cryotherapy during oxaliplatin administration

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: oxaliplatin + capecitabine<br>Patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-14. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients with complete response (CR) receive 2 additional courses after CR. Quality of life is assessed at baseline and then every 3 weeks (prior to each course of chemotherapy). Patients are followed every 3 months for 1 year and then every 6 months for 2 years. | Drug: capecitabine<br> <br> Drug: oxaliplatin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective tumor response rate |  | Up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to progression |  | Up to 3 years | 
| Overall survival |  | Up to 3 years | 
| Quality of life |  | Up to 3 years | 

 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 III esophageal cancer, stage IV esophageal cancer, recurrent esophageal cancer, adenocarcinoma of the stomach, adenocarcinoma of the esophagus