Docetaxel and Capecitabine in Treating Patients With Metastatic Cancer of the Stomach or Gastroes… (NCT00054457) | Clinical Trial Compass
CompletedPhase 2
Docetaxel and Capecitabine in Treating Patients With Metastatic Cancer of the Stomach or Gastroesophageal Junction
United States46 participantsStarted 2003-09
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…