Docetaxel and Capecitabine in Treating Patients With Metastatic Cancer of the Stomach or Gastroesophageal Junction

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 of the effectiveness of combining docetaxel with capecitabine in treating patients who have metastatic cancer of the stomach or gastroesophageal junction.

Detailed Description
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OBJECTIVES: Determine the objective tumor response rate in patients with metastatic gastric or gastroesophageal junction adenocarcinoma treated with docetaxel and capecitabine. Determine the time to progression in patients treated with this regimen. Determine the overall survival in patients treated with this regimen. Determine the toxic effects of this regimen in these patients. Determine whether interleukin-1 polymorphisms are present among patients who have weight loss vs no weight loss, and their relationship to a poor prognosis. Assess the quality of life and swallowing uniscale during chemotherapy in these patients. OUTLINE: Patients receive docetaxel IV over 1 hour on day 1 and oral capecitabine twice daily on days 1-14. Courses repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, at each tumor measurement, and at the end of treatment. Patients are followed every 3 months until disease progression and then every 6 months until 3 years from registration.

Official Title
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A Phase II Study Of Docetaxel And Capecitabine In Patients With Measurable Metastatic Adenocarcinoma Of The Stomach And Gastroesophageal Junction

Conditions
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Esophageal Cancer, Gastric Cancer

Intervention / Treatment
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* Drug: capecitabine
* Drug: docetaxel


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically or cytologically confirmed adenocarcinoma of the stomach or gastroesophageal junction Deemed unresectable and not a candidate for potentially curative treatment (e.g., surgical resection or combined modality therapy) At least 4 weeks since prior abdominal exploration with resection (3 weeks without resection) No other more conventional forms of therapy available with a reasonable chance of cure or significant palliation Measurable disease* The following are not considered measurable disease: Bone lesions Leptomeningeal disease Ascites Pleural/pericardial effusion Lymphangitis cutis/pulmonis Abdominal masses that are not confirmed and followed by imaging Cystic lesions NOTE: *Patients having only lesions measuring ≥ 1 cm to < 2 cm must use spiral CT scan for all tumor assessments. No untreated or treated but symptomatic 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 2.5 times ULN if alkaline phosphatase is less than ULN OR Alkaline phosphatase no greater than 4 times ULN if AST less than ULN Renal Creatinine normal Creatinine clearance at least 60 mL/min Cardiovascular No New York Heart Association class III or IV heart disease Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception Ability to swallow capecitabine No prior anaphylactic reaction to any taxane No prior severe reaction to fluoropyrimidine No prior poor tolerance to capecitabine No known sensitivity or poor tolerance to fluorouracil No known dihydropyrimidine dehydrogenase deficiency No uncontrolled infection No uncontrolled seizure disorder No chronic debilitating disease No peripheral neuropathy of any etiology greater than grade 1 No diabetes mellitus No other malignancy within the past 5 years except adequately treated basal cell or squamous cell carcinoma or adequately treated noninvasive carcinoma PRIOR CONCURRENT THERAPY: Biologic therapy No prior immunotherapy or biologic therapy for recurrent or metastatic disease No concurrent biologic therapy Chemotherapy No prior chemotherapy for recurrent or metastatic disease except for the following: Adjuvant chemotherapy after complete resection of the original tumor Neoadjuvant chemotherapy followed by surgical resection of the original tumor No other concurrent chemotherapy Endocrine therapy Not specified Radiotherapy No prior radiotherapy except for the following: Adjuvant radiotherapy after complete resection of the original tumor Neoadjuvant radiotherapy followed by surgical resection of the original tumor No prior radiotherapy to 25% or more of the bone marrow More than 4 weeks since prior radiotherapy No concurrent radiotherapy Surgery See Disease Characteristics No prior organ allograft Other No concurrent brivudine or sorivudine

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: docetaxel + capecitabine<br>Patients receive docetaxel IV over 1 hour on day 1 and oral capecitabine twice daily on days 1-14. Courses repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, at each tumor measurement, and at the end of treatment. Patients are followed every 3 months until disease progression and then every 6 months until 3 years from registration. | Drug: capecitabine<br> <br> Drug: docetaxel<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of successes |  | Up to 3.5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival time |  | Up to 3.5 years | 
| Time to disease progression |  | Up to 3.5 years | 
| Duration of response |  | Up to 3.5 years | 
| Time to treatment failure |  | Up to 3.5 years | 
| Quality of life as measured by the LASA, FACT-E and Patient Uniscale Swallowing questionnaires |  | Up to 3.5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adenocarcinoma of the stomach, adenocarcinoma of the esophagus, stage IV gastric cancer, recurrent gastric cancer, stage IV esophageal cancer, recurrent esophageal cancer