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:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-25 @ 2:49 AM
NCT ID:
NCT00004233
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically proven unresectable, locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction
* No known brain metastases
* Negative brain imaging required for neurologic signs and symptoms
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* Zubrod 0-1
Life expectancy:
* Not specified
Hematopoietic:
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count greater than 100,000/mm\^3
Hepatic:
* Bilirubin no greater than upper limit of normal (ULN)
* SGOT or SGPT no greater than 1.5 times ULN (5 times ULN if liver tumor present)
Renal:
* Creatinine no greater than ULN
Other:
* Not pregnant or nursing
* Fertile patients must use effective contraception
* Must be able to swallow oral medication
* No AIDS syndrome or HIV-associated complex
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No prior biologic therapy
* No concurrent biologic therapy
Chemotherapy:
* No prior chemotherapy for advanced or metastatic gastric cancer
* At least 6 months since prior chemotherapy as adjuvant or radiation sensitizer
Endocrine therapy:
* Not specified
Radiotherapy:
* At least 1 month since prior radiotherapy and recovered
* No concurrent radiotherapy
Surgery:
* At least 3 weeks since prior major surgical resection of intra-abdominal organs and recovered
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00004233
Study Brief:
Protocol Section:
NCT00004233