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 @ 7:18 PM
Ignite Modification Date:
2025-12-24 @ 7:18 PM
NCT ID:
NCT00103103
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of gastric or gastroesophageal junction adenocarcinoma
* Metastatic or unresectable disease
* Progressive disease after receiving 1 prior chemotherapy regimen for metastatic disease comprising 1 of the following:
* Fluorouracil
* Cisplatin and irinotecan
* Capecitabine
* Taxanes
* Measurable disease
* No esophageal cancer
* No brain metastases
PATIENT CHARACTERISTICS:
Age
* Over 18
Performance status
* ECOG 0-2 OR
* Karnofsky 60-100%
Life expectancy
* At least 3 months
Hematopoietic
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
Hepatic
* Bilirubin normal
* AST and ALT ≤ 2.5 times upper limit of normal
Renal
* Creatinine ≤ 1.5 mg/dL
Cardiovascular
* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia
* No acute ischemia by EKG
* No significant conduction abnormality by EKG, including either of the following:
* Bifasicular block, defined as left anterior hemiblock in the presence of right bundle branch block
* Second or third degree atrioventricular block
* No history of cardiac or cerebrovascular disease due to hypotension and tachycardia
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception before, during, and for 6 months after study participation
* No ongoing or active infection
* No other uncontrolled illness
* No peripheral neuropathy ≥ grade 2 within the past 2 weeks
* No allergy to boron or mannitol
PRIOR CONCURRENT THERAPY:
Biologic therapy
* More than 4 weeks since prior immunotherapy
Chemotherapy
* More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered
Endocrine therapy
* Not specified
Radiotherapy
* More than 4 weeks since prior radiotherapy and recovered
Surgery
* More than 2 weeks since prior major surgery
Other
* No concurrent highly active anti-retroviral therapy for HIV-positive patients
* No other concurrent investigational agents
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00103103
Study Brief:
Protocol Section:
NCT00103103