Docetaxel and Capecitabine in Treating Patients With Metastatic Cancer of the Stomach or Gastroesophageal Junction
Esophageal Cancer, Gastric Cancer
About this trial
This is an interventional treatment trial for Esophageal Cancer focused on measuring adenocarcinoma of the stomach, adenocarcinoma of the esophagus, stage IV gastric cancer, recurrent gastric cancer, stage IV esophageal cancer, recurrent esophageal cancer
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
Sites / Locations
- Cancer Center of Kansas, PA - Chanute
- Cancer Center of Kansas, PA - Dodge City
- Cancer Center of Kansas, PA - El Dorado
- Cancer Center of Kansas, PA - Kingman
- Southwest Medical Center
- Cancer Center of Kansas, PA - Newton
- Cancer Center of Kansas, PA - Parsons
- Cancer Center of Kansas, PA - Pratt
- Cancer Center of Kansas, PA - Salina
- Cancer Center of Kansas, PA - Wellington
- Associates in Womens Health, PA - North Review
- Cancer Center of Kansas, PA - Medical Arts Tower
- Cancer Center of Kansas, PA - Wichita
- CCOP - Wichita
- Via Christi Cancer Center at Via Christi Regional Medical Center
- Cancer Center of Kansas, PA - Winfield
- Fairview Ridges Hospital
- Mercy and Unity Cancer Center at Mercy Hospital
- Fairview Southdale Hospital
- Mercy and Unity Cancer Center at Unity Hospital
- Minnesota Oncology Hematology, PA - Maplewood
- Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
- Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
- CCOP - Metro-Minnesota
- Park Nicollet Cancer Center
- United Hospital
- Ridgeview Medical Center
- Minnesota Oncology Hematology, PA - Woodbury
Arms of the Study
Arm 1
Experimental
docetaxel + capecitabine
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.