Esophageal Cancer Clinical Trial
Docetaxel and Capecitabine in Treating Patients With Metastatic Cancer of the Stomach or Gastroesophageal Junction
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 of the effectiveness of combining docetaxel with capecitabine in treating patients who have metastatic cancer of the stomach or gastroesophageal junction.
Full Description
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.
Eligibility Criteria
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
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There are 24 Locations for this study
Chanute Kansas, 66720, United States
Dodge City Kansas, 67801, United States
El Dorado Kansas, 67042, United States
Kingman Kansas, 67068, United States
Liberal Kansas, 67901, United States
Newton Kansas, 67114, United States
Parsons Kansas, 67357, United States
Pratt Kansas, 67124, United States
Salina Kansas, 67042, United States
Wellington Kansas, 67152, United States
Wichita Kansas, 67203, United States
Wichita Kansas, 67208, United States
Wichita Kansas, 67214, United States
Wichita Kansas, 67214, United States
Wichita Kansas, 67214, United States
Winfield Kansas, 67156, United States
Burnsville Minnesota, 55337, United States
Coon Rapids Minnesota, 55433, United States
Edina Minnesota, 55435, United States
Fridley Minnesota, 55432, United States
Maplewood Minnesota, 55109, United States
Minneapolis Minnesota, 55407, United States
Robbinsdale Minnesota, 55422, United States
Saint Louis Park Minnesota, 55416, United States
St. Louis Park Minnesota, 55416, United States
St. Paul Minnesota, 55102, United States
Waconia Minnesota, 55387, United States
Woodbury Minnesota, 55125, United States
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