Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2025-12-24 @ 6:40 PM
NCT ID:
NCT00054457
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00054457
Study Brief:
Protocol Section:
NCT00054457